Longevity Industry Jobs

Denali is continuing to build a leading and innovative Biotherapeutic Discovery organization that will strongly contribute to the discovery and development of novel therapeutics for neurodegenerative diseases. We are currently seeking a talented and highly motivated scientist to join our Antibody Discovery & Protein Engineering Group to contribute to the discovery and characterization of monoclonal antibodies using hybridoma and/or B cell technologies. The successful candidate will play a key role as antibody discovery lead on internal project teams and external collaborations while utilizing a broad range of immunology, molecular biology, biochemistry and cell-based technologies to support therapeutic programs and reagent tool antibody generations.

Responsibilities

• Design and execute antibody discovery campaigns using optimally targeted immunization strategies, hybridoma and/or B cell technologies and high-throughput multi-parameter antibody screening assays to generate highly diverse panels of antibodies
• Partner closely with AD&PE group members and work well in a team environment to achieve the operational goals of antibody discovery
• Collaborate with scientists in Biotherapeutic Discovery, Discovery Biology, Discovery Pharmacology and Translational Sciences, to identify lead panels of therapeutic candidates and tool antibodies to achieve program goals
• Provide support and input for antibody discovery projects with external partners/CROs

Requirements

• PhD in Cell Biology, Biochemistry, Immunology or related field with 0+ year experience, MS with 5+ years of industry experience or BS with 10+ years of industry experience
• Hands-on experience with hybridoma generation/propagation/cloning and B cell isolation/propagation/cloning for antibody discovery
• Extensive experience with cell culture is required
• Experience with immunization strategy design using wild-type and transgenic animals to generate high-diversity antibody panels
• Experience in high-throughput antibody screening methodologies including ELISA, flow cytometry and other immunoassay technologies such as MSD, AlphaLisa and HTRF is highly desirable
• Experience in molecular biology techniques including molecular cloning of antibody sequences from hybridomas/B cells, NGS sequencing, recombinant plasmid construction for protein expression is highly desirable
• Experience in cell-based assays such as Fc effector function assays (ADCC, CDC and ADCP) and cell proliferation assays is desired
• Ability to contribute to multiple projects in a fast-paced environment
• Highly organized with excellent communication and critical thinking skills
• Self-motivated, highly collaborative and team-work oriented personality
• Proven track record of problem solving and ability to pick up conceptual and technical novelties as demonstrated by publications and/or patents

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $142,000 to $174,333. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

The Senior Manager, Patient Advocacy and Engagement will be responsible for supporting relationships with the patient community and advocacy organizations across the Denali therapeutic portfolio. The Senior Manager, Patient Advocacy & Engagement role serves as a liaison among patients, families, advocates, the community, and Denali in the development of clinical trial protocol, patient & caregiver materials, and external communications. Based on the understanding and relationships of the patient community and internal corporate objectives, the senior manager will draw upon these two perspectives to drive patient advocacy strategy that supports the patient communities we serve, helps Denali achieve its objectives, and fosters a corporate reputation as a trusted and credible partner with the patient advocacy and broader patient communities. This position reports to the Director, Patient Advocacy.

Your Contributions (Include, But Are Not Limited To)

• Identify, develop, and cultivate trust-based relationships with patient advocacy and influential community leaders consistent with the phase of development of Denali clinical programs.
• Assist in executing strategic plans for patient advocacy and stakeholder engagement across Denali programs/therapeutic areas.
• Collaborate with corporate communications, clinical operations, other cross functional teams, and external agencies to develop patient/advocate materials for Denali clinical programs and clinical trials
• Work closely with Clinical Operations to support clinical trial awareness and retention
• Support a Frequently Asked Questions database for patients and advocates across our clinical programs
• Monitor patients@dnli.com e-mailbox and support appropriate and compliant responses
• Assist in seeing collateral through the Denali legal/medical and regulatory review process
• Execute stakeholder mapping across Denali therapeutic areas
• Assist in managing a budget for patient advocacy group support, including the submission, and tracking of sponsorship & membership requests through internal review, contracting and payment
• Assist in supporting and organizing Patient Advisory Boards and Committees, as needed, in support of clinical programs.
• Represent the Patient Engagement & Advocacy function on key internal teams, educate other functions on the patient engagement & advocacy landscape
• Serve as an internal support for events where we invite the patient community to Denali to share their experiences with the entire company (All Hands Meetings, Disease Awareness Days, etc.)
• Represent the company at key patient advocacy group conferences, medical congresses, and other patient community meetings
• Ensure compliance with corporate policies and procedures, as well as applicable laws and regulations.
• Be a steward and the voice of patients at Denali and propel our patient focused culture

Requirements

• Bachelor's degree required. Communications or agency background is a plus. Equivalent combination of education and applicable job experience may be considered.
• Minimum 5+ years of relevant experience.
• Minimum 1+ years of experience with the pharmaceutical/medical/healthcare industry.
• 3+ years prior patient advocacy experience is preferred. (working within a non-profit patient group a plus)
• Neurodegeneration (Alzheimer’s, Parkinson’s, ALS) and rare disease experience desired; experience in ALS a plus.
• Experience with clinical trial engagement a plus
• Experience with and understanding of the drug development process
• Interest and capacity to learn and understand the Denali science.
• Sensitivity to diverse groups of individuals both internal and external with the ability to manage many different opinions and perspectives.
• Outstanding interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Ability to influence others and drive alignment across diverse teams
• Empathic and passionate individual with the ability to build meaningful connections with internal and external stakeholders and drive change
• Ability to travel domestically 20-30% on a regular basis, with occasional international travel as required.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $157,000 to $187,667. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers . This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is continuing to build a leading, innovative Discovery organization that will strongly contribute to the discovery and development of novel therapeutics for neurodegenerative diseases. This is an exciting and unique opportunity to contribute to our Small Molecule Discovery platform as we tackle a range of therapeutic drug targets. We are currently seeking an excellent organic chemist to join our Small Molecule Discovery team in South San Francisco, California.

Responsibilities

• Contribute to the discovery of disease-modifying therapies for highly unmet medical needs
• Actively participate in interdisciplinary research collaborations with Denali scientists and other leading academic and industrial research groups
• Work collaboratively with colleagues across Research and Development to advance therapeutic programs through our Discovery pipeline
• Design, synthesize, purify, and characterize biologically active compounds
• Develop and implement strategies for lead identification and optimization
• Establish and manage activities at partner Contract Research Organizations
• Contribute to the growth of our internal Small Molecule Discovery team

Successful Candidates Will Meet Most Of These Criteria

• Ph.D. in Chemistry or related scientific discipline or M.Sc./B.Sc. with ≥5 years of relevant experience in biotech/biopharma
• A deep understanding and demonstrated excellence in organic synthetic chemistry and chemical biology
• A record of scientific leadership and innovation as demonstrated by publications and/or identification of drug candidates
• Experience with a variety of isolation and analytical methods for compound purification and characterization including TLC, column chromatography, LCMS, HPLC, MS and NMR
• Strong leadership skills with the ability to plan and achieve research goals in an organizationally diverse research environment
• Innovative, non-hierarchical approach with high energy
• Strong written and verbal communication skills
• Highly organized with the ability to effectively prioritize individual and group tasks
• Ability to work in a fast-paced environment

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $129,000 to $163,667. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

In anticipation of the Company’s growth plans, Denali Therapeutics is looking for an Executive Director, Global Medical Safety. This role will be responsible for directing and implementing all aspects of safety strategy for assigned Denali programs. The successful candidate will be experienced in the medical and scientific safety assessment in all phases of clinical development as well as in successful NDA/BLA submissions and continued post-approval safety surveillance. He/she will be a proven collaborator and self-starter who has the ability to thrive in a matrixed environment; and has leadership experience in leading safety aspects of clinical development for multiple programs.

Responsibilities

• Under supervision of the VP, Head of Drug Safety, and as per company policies and procedures, for assigned Denali programs, has the responsibility and oversight of the risk-benefit strategy and execution
• Responsible for program-level safety strategic planning, implementation, and management of drug safety activities to support clinical development through optimized benefit-risk for patients.
• Responsible for leading the program level Safety Management Team(s) to develop and execute plans pertaining to safety signal management, safety surveillance and risk. Responsible for risk characterization and internal/external safety communication for the molecule. Provide expert safety review and safety content for critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs
• Provides medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database
• Responsible for responding to and resolving safety questions from regulatory authorities.
• Responsible for the production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide
• Collaborates for consistency in safety approaches within drug safety group and with cross-functional colleagues, e.g. medical monitors, toxicologist and pharmacologist
• Support regulatory agency audits and inspections, and corrective action plans
• Support overall growth and operations of Denali and the Drug Safety department. Lead initiatives in developing safety processes and and continuous pharmacovigilance (PV) process improvement. Support PV vendor oversight in collaboration with Safety Operations

Minimum Qualifications

• Advanced medical degree (e.g., MD, MBBS, DO) required
• 7+ years of experience in the pharmaceutical industry. A minimum of 3 years leading cross-functional safety teams in the clinical trial and post- marketing environments.
• Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
• Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics
• Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $296,667 to $345,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is seeking a Scientist in support of small molecule and biomarker bioanalysis efforts within the Bioanalysis group. You will work closely with DMPK, Omics and Biomarker scientists, develop LC-MS/MS methods, and quantitate drug candidates, metabolites, and biomarkers from in vitro and in vivo samples.

Responsibilities

• Develop and qualify fit-for-purpose LC-MS/MS assays; perform assay maintenance testing of LC-MS/MS methods
• Perform bioanalysis of small molecules and biomarkers in various biological matrices including plasma, urine, CSF, and tissues
• Work with novel biotherapeutic analytes and contribute to development of mass spectrometry methods and analyses for oligonucleotides and proteins
• Work with DMPK scientists to develop assays to support in vitro ADME and PK studies
• Interpret data, write scientific reports, review, and QC incoming data from CROs, and communicate bioanalysis results to other scientists and project teams

Basic Qualifications

• PhD in Analytical Chemistry, Pharmaceutical Chemistry, Drug Metabolism,Pharmacokinetics, or related scientific discipline
• OR Master's degree and 3+ years of biotech/pharmaceutical or CRO experience in LC-MS/MS bioanalysis
• OR Bachelor's degree and 6+ years of biotech/pharmaceutical or CRO experience in LC-MS/MS bioanalysis
• Hands-on experience with various sample preparation techniques (protein precipitation, liquid-liquid extraction, and solid-phase extraction), chromatographic separation, and operation of triple-quadrupole mass spectrometers
• Demonstrated ability to work effectively and collaboratively with other scientists on cross- functional Project Teams
• Excellent oral presentation and written communication skills

Preferred Qualifications

• Working knowledge of quantitative bioanalytical principles, with GLP/GCP regulated assay

Experience

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $121,000 - $153,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

We are seeking to recruit a Principal Scientist for the Clinical Data Science / Statistical Programming Group with experience supporting drug development, medical device, or clinical study projects; and has excellent statistical programming and problem-solving skills to support our clinical development programs. The ideal candidate will be able to function as a leader and individual contributor, will take the initiative to stay current on technologies and methods, come up with innovative solutions to challenging problems, and work with Biometrics management to help set the overall strategic direction of the group. As a member of the Biometrics team at Denali Therapeutics, the candidate will work closely with clinical study team members and biometrics colleagues. The candidate will have the opportunity to help shape Denali’s data and programming infrastructure, gain an in-depth understanding of drug development in a fast-moving industry environment and subject domain knowledge in the field of neurodegeneration.

Primary Responsibilities

• Represent data science on study execution teams. Study execution support will include creation of datasets, data visualizations or summary reports to support internal decision making and regulatory interactions (IND/CTA filings, annual safety reporting, etc.).
• Providing input for study data standardization plan, study protocols, statistical analysis plans, randomization specifications, and clinical study reports.
• Partner with Clinical Data Management to provide input for case report form design, data review plans, and external data transfer specifications.
• Collaborate with study team and external functions (e.g., CROs, specialty lab vendors, clinical development partners, etc) to ensure meeting project timelines and goals
• Provide technical leadership in designing, developing, and validating of clinical trial data for regulatory submissions in CDISC (SDTM, ADaM, Define.xml, SDRG, ADRG, aCRF and P21 checks, etc..) format
• Develop and manage reusable code for interactive data visualization and analytics tools for reporting and exploratory analysis.
• Lead and/or support the biometrics team in efforts to build, maintain, and continuously improve an SAS/R infrastructure that is suitable for regulatory submission work.
• Curate tidy analysis data for use with statistical reporting code and analytics applications.
• Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies.
• Perform programmatic review of analysis datasets and TLFs generated by programming teams, ensure high quality of deliverables, conduct Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS)
• Work with the biometrics team to establish innovative processes to ensure high data quality, reporting of analysis results, and analysis reproducibility.
• Support data science and biometric functional initiatives. Lead/participate in departmental or cross-functional working groups and process improvement activities.
• Effectively interact with external programming resources, including contributing to development and/or review of contract specifications and feedback on performance.
• Act as mentor and train data scientists/statistical programmers regarding programming techniques, project management, and implementation of standards.
• Contribute to the recruitment and retention of both permanent and contract talent.

Must Have Qualifications

• At a minimum, a bachelor’s degree in Statistics, Biostatistics, Data Science, Mathematics, or related field.
• 8+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies.
• Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).
• Prior direct report management experience including mentoring, training, and enabling staff to grow professionally.
• Extensive applied experience with SDTM and ADaM CDISC data standards and health authority submission of data; or familiarity and exposure to CDISC standards (i.e., SDTM, ADaM) for regulatory submissions and willingness to become a subject matter expert in applying these standards.
• Knowledge of regulatory requirements concerning electronic submission standards and experience in delivering one or more submissions to regulatory authorities globally.
• In depth knowledge of statistical programming languages such as SAS (including Base, STAT, Macro and GRAPH), R (including tidyverse, RMarkdown, Shiny, htmlwidgets, development of R packages), and common technology platforms
• Demonstrated experience in creating compelling data visualizations to help teams make correct data driven decisions and effectively communicating results to team members.
• Able to demonstrate a solid understanding of statistical principles and methods used in clinical study reports or scientific publication analyses.
• Experience applying software development concepts, and proficiency in using Git/GitHub for collaboration and versioning of operational, robust, and well documented code.
• Demonstrated ability to effectively lead projects and collaborate cross-functionally.
• Able to work in a Linux/Unix environment (including shell scripting).
• Working knowledge of relevant FDA, EMA, PMDA, HC and ICH guidelines and regulations.

Preferred Qualifications

• Prior work experience with pharmacokinetic data and the neuroscience field,
• proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux, and git),
• Experience with Amazon Web Services and cloud infrastructure, and experience with applying machine learning techniques.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $167,000 to $203,667. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is seeking a Senior EH&S Specialist to join our team. The ideal candidate will have experience in waste management and chemical safety, as well as a strong understanding of EH&S regulations and best practices.

Responsibilities

• Oversee day-to-day compliance with EH&S policies and regulations
• Conduct regular waste rounds to ensure proper storage and disposal of waste materials
• Procure and manage waste containers, including arranging for regular pickups
• Support equipment decontamination, spill response, and lab pack activities
• Ensure proper labeling and signage of waste containers and areas
• Conduct lab inspections and follow-up on any identified issues
• Conduct Job Hazard Analysis (JHA) for new processes/operations/activities
• Utilize EHS Management Tool to track and manage EH&S data
• Evaluate and recommend appropriate PPE for employees
• Provide regular presentations and updates on EH&S topics to functional groups
• Consolidate safety metrics and findings for functional groups to identify trends and areas for improvement
• Investigate incidents and near-misses to determine root causes and implement corrective actions
• Develop EH&S policies, programs and trainings, as needed
• Develop and implement a chemical safety/high hazard categorization program to ensure proper segregation of chemicals

Basic Qualifications

• Bachelor's degree in EH&S, Environmental Science, or a related field
• 5+ years of experience in an EH&S role, with a focus on waste management and chemical safety
• 40 Hour Hazwoper certification required
• Strong understanding of EH&S regulations and best practices
• Excellent communication and presentation skills
• Experience in conducting incident investigations with root cause analysis
• Ability to work independently and as part of a team
• Strong attention to detail and problem-solving skills

Preferred Qualifications

• Professional Certification preferred (e.g. CHMM, CSP, etc.)
• Experience with EHS Management Tools is a plus
• Experience in Biotech/Pharma companies is a plus

This is a full-time position with competitive salary and benefits. If you are passionate about EH&S and have the skills and experience we are looking for, we encourage you to apply.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $104,000- $125,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali Therapeutics is seeking a Senior Manager, Biomarker Operations in support of the company’s Development Operations group. You will manage the biospecimen lifecycle for Denali’s clinical programs through collaboration with Clinical Operations, Data Management, Translational Science, Biomarker and Pharmacology scientists, and external vendors that support Denali’s clinical studies. You will also supervise and train BMO clinical study leads.

Responsibilities

• Development of biospecimen lifecycle strategies through close collaboration with project teams and biomarker scientists
• Ensure program level consistency and cross-program standardization of biospecimen collection, processing, storage, and analysis
• Supervise, support and train Biomarker Operations clinical study leads
• Contribute to development of study protocols, ICFs and other relevant study documents
• Collaborate with Clinical Operations, Procurement and Quality in the selection and management of central laboratories and specialty bioanalysis labs to ensure they meet study requirements and adhere to relevant compliance standards
• Manage the creation of complex sample management plans and laboratory documents that ensure the proper collection and storage of samples at clinical sites
• Create systems and tools to manage sample analysis plans and enable study leads to deliver samples to appropriate analysis vendors on time
• Facilitate biomarker vendor interactions with Data Management to ensure consistency in the transmission of sample metadata for accurate identification of analyzed samples
• Design LIMS study collection plans to allow real-time import of incoming samples into Biosample Management’s LIMS Database. This requires coordination with scientists, CROs and vendors and ability to interpret clinical study protocols.
• Lead process improvement projects

Basic Qualifications

• Bachelor’s degree in Biology, Immunology, Neuroscience, Medical Technology, or related field plus 7+ years of experience in Clinical Operations, Translational Sciences, Biomarker Operations,
• OR combination of advanced degree in relevant field with 5+ years of experience
• Ability to lead effectively in a cross-functional team matrix environment
• Working knowledge of biosample management for clinical trials. Familiarity with relevant FDA & ICH/GCP regulations is
• Ability to review and interpret clinical research protocols
• Technical know how to create tools to solve operational challenges and improve workflows
• Entrepreneurial spirit with “can do” attitude and commitment to work as part of a team
• Seeks change & values innovation
• Advanced planning and organization skills and excellent analytical skills

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $158,000 - $181,333. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali Therapeutics is seeking an experienced Senior Project Administrative Coordinator who will provide business and administrative support of a substantial and confidential nature.

Responsibilities

• Manage multiple projects simultaneously. Anticipate and track dates, events, and associated action items; follow up with appropriate parties to ensure deadlines are met.
• Confidentially coordinate activities for assigned members of Denali Senior Leadership. This includes management of a complex calendar(s) and organizing BOD, advisory and investor meetings.
• Coordinate travel arrangements and associated logistics with shifting priorities and deadlines. Plan and organize meetings, prepare agendas, provide research and background information, create presentations and coordinate all logistics.
• Represent Senior Leadership to external constituencies by serving as the primary point of contact and assessing requests and questions. Make autonomous, accurate and swift judgments, including forwarding questions and requests to other senior staff.
• Prepare Senior Leadership for internal/external meetings by researching organizations and individuals, bringing together resources to aid in preparation, and compile relevant materials.
• Anticipate the business needs for Denali Senior Leadership and senior team by proactively formulating and evaluating solutions and/or recommendations to facilitate meeting deadlines and achieving goals.
• Compose correspondence. Develop, review, and edit presentations and documentation.
• Independently research and analyze associated issues and/or compile materials needed for presentation and/or decision-making purposes.
• Manage multiple projects simultaneously. Anticipate and track initial dates, events, and associated action items; follow up with appropriate parties on behalf of supervisor to ensure deadlines are met.
• Support event planning and execution.

Basic Qualifications

• Highschool diploma or equivalent
• 5+ years of administrative experience supporting C level executives
• Proven track record of supporting senior-level leadership
• Demonstrated ability to handle sensitive issues and maintain the utmost confidentiality
• Demonstrated ability to perform duties with a high level of professionalism, flexibility, discretion, judgment, diplomacy, and tact
• Exemplary internal and external interpersonal and customer service skills
• Ability to multitask, adapt to changing priorities and deadlines
• Advanced computer skills and demonstrated experience with office software and G-Suite
• Excellent verbal and written communication skills, including editing and proofreading
• Growth mindset with interest and curiosity to learn new things
• Ability to adapt to changes in a rapidly scaling organization
• Excellent planning and organizational skills
• Ability to take initiative and ownership of projects

Preferred Qualifications

• Bachelor’s degree
• Biotech industry experience
• Previous experience working for a global organization

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $95,000-$114,150. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

In anticipation of the Company’s growth plans, Denali Therapeutics is seeking to recruit a Director of Oligonucleotide Development and Manufacturing. The Director of Oligonucleotide Development and Manufacturing will provide strategic direction for oligonucleotide and oligonucleotide-linker development and manufacturing from early to late-stage development. S/he will work in close collaboration with colleagues in Therapeutic Discovery, Technical Operations, Quality and Compliance, and Regulatory. The individual will be responsible for overseeing and managing all oligonucleotide process & analytical development and manufacturing activities, both internally and externally performed. In addition, this individual will write, edit, and finalize CMC sections of global regulatory filings and will play a key role in interactions with health authorities.

Responsibilities

• Provide leadership and develop CMC strategies for oligonucleotide-related clinical candidates
• Lead and oversee (including hands on) phase appropriate process and analytical development for oligonucleotide, linker and oligonucleotide-linker candidates in development
• Collaborate with Discovery, Large Molecule CMC Development, Quality and Program Management functions to deliver oligonucleotide and oligonucleotide-linker (GLP and GMP) to support all nonclinical and clinical programs. Plan and allocate resources
• Foster innovative mindset and continuously improve Denali’s technical and scientific capabilities by demonstrating new technologies and skills as needed
• Review, edit, and finalize RFPs as well as protocols, amendments, and reports that meet global regulatory and compliance requirements. Execute the oligo-linker manufacturing campaigns at external CDMOs
• Write, edit, and finalize CMC sections for regulatory filings
• Oversee, contract, manage and monitor outsourced manufacturing activities and ensure the timely delivery of the oligonucleotide-linker in compliant manner
• Build internal oligonucleotide process and analytical development capabilities as appropriate

Requirements

• PhD in Chemistry, Engineering or related scientific discipline, with a minimum of 8 years of relevant biotech/pharmaceutical experience
• Strong knowledge in the solid phase synthesis and purification of oligonucleotide as well as in analytics for oligonucleotides.
• Experience in selecting and managing third party CDMOs to manufacture oligonucleotides under cGMP. Extensive experience with outsourcing and vendor management.
• Excellent critical thinking and scientific skills and a demonstrated ability to interpret and clearly communicate complex data.
• In-depth understanding of regulatory, compliance, and quality requirements for oligonucleotide-based drugs.
• Demonstrated leadership skills and the ability to work effectively and collaboratively on cross-functional projects teams.
• Excellent oral, presentation, and written communication skills; an ability to multitask and successfully deliver on timelines in a dynamic, fast-paced environment
• Ability to thrive in a multi-tasking and complex environment with limited resources and have flexibility to adapt to changing demands or priorities based on corporate goals.
• Ability to travel to manage and monitor outsourced activities

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $215,000.00 to $243,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

The Denali Head of GMP/GLP Quality, reporting to the Chief Technical & Manufacturing Officer, is responsible for the strategic and technical leadership of all aspects of Quality Assurance & Quality Control for Denali’s therapeutic products. This individual is accountable for the strategic leadership of the function, building & managing appropriate Quality systems and overseeing activities to ensure safe & effective products are delivered to patients. Accountabilities include identifying & mitigating GMP risks, execution of Quality Agreements, batch record review, evaluation of methods and specifications, and CMO audits. This individual is also accountable for developing collaborative and productive partnerships across Denali as well as external contract manufacturing organizations, study site pharmacies, and QPs. Denali is seeking candidates with a collaborative, solution finding attitude who operate with the highest integrity, embrace an atmosphere of growth & continuous improvement, and share our commitment to data-driven decision making.

Primary Responsibilities

• Ensure effective and efficient completion of key technical deliverables including Quality Agreements, batch record review, method validation
• Oversee the Quality Management System and modify & develop as needed to meet the growing needs of the organization
• Support investigational new drug applications (IND), ex-US clinical trial applications (CTA), new drug applications (NDA/BLA/MAA) and related correspondence from the US Food and Drug Administration (FDA) and other global regulatory authorities
• Manage internal and external audits
• Participates in cross-functional teams, providing feedback and support
• Partner with external vendors in support of Quality document preparation and submission
• Maintain up-to-date knowledge of the Quality landscape, regulations, and guidelines
• Support development of specifications for biologics and small molecule programs
• Identify GMP risks and mitigation plans
• Ensure compliance with relevant governing laws, regulations, guidelines, and Denali SOPs

Requirements

• 15+ years relevant experience in GMP Quality or relevant functions, and experience in both biologics and small molecule quality is highly desirable
• Bachelor’s degree required, and advanced scientific degree desirable
• Broad understanding of international regulations and guidance
• Strong experience in IND and CTA filings. NDA/BLA/MAA experience strongly preferred
• Experience in auditing CMOs and managing internal audits desirable
• Excellent written and verbal communication skills
• Exceptional influencing, partnership, and collaboration skills
• Strong ability to prioritize workload and manage the growth & development of employees
• Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners
• Able to prospectively identify potential problems and to partner effectively and positively to solve issues

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $265,000.00 to $309,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

In anticipation of the Company’s growth plans, Denali Therapeutics is looking for an Executive Director, Global Medical Safety. This role will be responsible for directing and implementing all aspects of safety strategy for assigned Denali programs. The successful candidate will be experienced in the medical and scientific safety assessment in all phases of clinical development as well as in successful NDA/BLA submissions and continued post-approval safety surveillance. He/she will be a proven collaborator and self-starter who has the ability to thrive in a matrixed environment; and has leadership experience in leading safety aspects of clinical development for multiple programs.

Responsibilities

• Under supervision of the VP, Head of Drug Safety, and as per company policies and procedures, for assigned Denali programs, has the responsibility and oversight of the risk-benefit strategy and execution
• Responsible for program-level safety strategic planning, implementation, and management of drug safety activities to support clinical development through optimized benefit-risk for patients.
• Responsible for leading the program level Safety Management Team(s) to develop and execute plans pertaining to safety signal management, safety surveillance and risk. Responsible for risk characterization and internal/external safety communication for the molecule. Provide expert safety review and safety content for critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs
• Provides medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database
• Responsible for responding to and resolving safety questions from regulatory authorities.
• Responsible for the production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide
• Collaborates for consistency in safety approaches within drug safety group and with cross-functional colleagues, e.g. medical monitors, toxicologist and pharmacologist
• Support regulatory agency audits and inspections, and corrective action plans
• Support overall growth and operations of Denali and the Drug Safety department. Lead initiatives in developing safety processes and and continuous pharmacovigilance (PV) process improvement. Support PV vendor oversight in collaboration with Safety Operations

Minimum Qualifications

• Advanced medical degree (e.g., MD, MBBS, DO) required
• 7+ years of experience in the pharmaceutical industry. A minimum of 3 years leading cross-functional safety teams in the clinical trial and post- marketing environments.
• Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
• Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics
• Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications

The Clinical Trial Manager (CTM) is responsible managing the day-to-day operations of assigned clinical studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. The CTM will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with Denali SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.

Responsibilities

• Lead/support internal cross-functional study execution team for assigned stud(ies) and/or assigned stud(ies) region to identify risks and mitigations strategies.
• Lead/support preparation of vendor requirements and project scope and selection of study vendors
• Manage clinical research organizations to ensure timely and quality deliverables.
• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Lead/support feasibility assessment and selection of countries and sites for study conduct.
• Lead/support the development of study plans and system set-up and UAT and ensure operational excellence of protocol, CRF, CSR and other key study deliverables.
• Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
• Oversee the quality of the clinical trial master files.
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
• Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals).
• Ensure set-up and implementation of effective investigator and site monitor training
• Create and conduct study-specific training at investigator meetings.
• Review study invoices and participate in accrual reviews to track the financial status of the study against budget.
• All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.

Requirements

• Bachelor’s degree required. RN/PA with professional clinical experience, and/or Master’s degree or higher in health-related science or equivalent preferred.
• 4+ years in a pharmaceutical setting (sponsor side experience a plus) with 2+ years of trial management experience required.
• Excellent organizational skills and attention to detail.
• Effective communication and interpersonal skills.
• Ability to efficiently perform multiple tasks and manage changing priorities.
• Ability to identify and solve logistical problems.
• Demonstrate proficiency in Microsoft Word, PowerPoint and Excel.
• Ability to build strong relationships with co-workers of various backgrounds and expertise.
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
• Values-based leadership consistent with Denali's Core Values.
• Excitement about the vision and mission of Denali.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $136,000 to $157,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

In anticipation of the Company’s growth plans, Denali Therapeutics is seeking to recruit a Clinical Trial Associate. The Clinical Trial Associate will provide support to the Clinical Development in the preparation of, monitoring, and conduct of clinical research studies.

Responsibilities

• Provide logistical support for Study Team.
• Develop, maintain and manage appropriate study documentation.
• Collect, review and approve regulatory documents from clinical sites.
• Initiate, maintain and reconcile Trial Master File.
• Set up and maintain tracking systems and tools and report study metrics to support the clinical study.
• Coordinate communication of tracking information within Study Team and to sites.
• Manage and track clinical and non-clinical supplies.
• Manage and track study-specific payments.
• Maintain working knowledge of company SOP’, GCP’s and FDA regulations
• Coordinate investigator meeting planning in concert with travel planners, including preparing meeting materials and on-site meeting implementation (as requested).
• Develop study related documents in collaboration with the study team

Requirements

• BS/MS degree (science based)
• 2+ years industry experience
• Working knowledge of regulatory and ICH/GCP guidelines
• Experience with study start-up activities, and conduct of clinical trials especially first-in-human and proof of concept studies.
• Therapeutic experience in neurology preferred
• Strong oral/written communication skills
• “Can do”, “pitch in” positive attitude

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $95,000 to $111,667. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

The Denali Sr. Manager of GxP Training, reporting to the Head of Development Quality, is accountable for defining and delivering the strategy and execution for Denali’s employee GxP Training program. This includes strategic management of the organization’s GxP Learning Management System (LMS), and building the GxP training team. This role will work closely with training partners and GxP functions to develop and deliver best-in-class training strategies while ensuring a high level of GxP training compliance across the organization.

Key Responsibilities

Responsible for collaborating and consulting with internal stakeholders to create, revise, and maintain curricula, training items and user groups in the Learning Management System (LMS)

• Oversee the development and delivery of training utilizing multiple platforms (i.e. face-to-face, e-learning, webinars, etc.).
• Promote a quality culture at Denali to drive enthusiasm for learning and training compliance
• Prioritize training needs using a risk-based approach with a philosophy of delivering the right training at the right time
• Provide metrics as directed to Quality groups to measure the effectiveness of GxP training programs within Denali
• Maintain and implement GxP training policies and procedures. Identify opportunities for improvements.
• Partner with the other Learning leaders in the organization to ensure that the GxP training strategy and delivery is aligned within Denali’s overall L&D standards and philosophy. Actively collaborate and present solutions to contribute to a seamless learning experience for Denali employees as the GxP Training SME.
• Coach Subject Matter Experts on GxP course and curriculum development
• Facilitate and oversee a range of learning opportunities to ensure employees across the organization have the skills needed to be effective, qualified and compliant in their GxP roles/functions

Requirements

• Proven track record managing a Gxp Training program within highly regulated healthcare, biotech, or pharmaceutical environments
• Always operates with the highest level of integrity and transparency
• Enthusiasm and passion for the role GxP training plays in bringing safe, effective treatments to patients
• Advanced relevant degree preferred, or 5+ years of related experience
• Excellent understanding of LMS best practices to meet learners’ needs and fulfill compliance objectives
• Ability to negotiate, influence, and facilitate
• Current knowledge of effective learning and development methods, and passion for continuous improvement
• Familiarity with e-learning platforms and practices
• Ability to support audits and inspections as the GxP Training SME as directed
• Excellent communicator and ability to work productively with a wide variety of stakeholders
• Able to work in a quickly changing and demanding environment
• Team-oriented with ability to listen, adapt and respond to changing needs
• Must be comfortable with both strategy and execution

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $130,300 to $170,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is continuing to build a leading and innovative Discovery organization that will strongly contribute to the discovery and development of novel therapeutics for neurodegenerative diseases. We are seeking an individual to design and synthesize oligonucleotide-based therapeutics across our Small Molecule Discovery and Oligonucleotide Transport Vehicle (OTV) platforms. This is an exciting and unique opportunity to contribute to multiple programs across our portfolio as we tackle a range of therapeutic drug targets.

Responsibilities

• Design, synthesize, purify, and characterize biologically active compounds including oligonucleotides, oligonucleotide-linker conjugates, and antibody-linker-oligonucleotide bioconjugates at microgram to gram scales
• Contribute to the discovery of disease-modifying therapies for highly unmet medical needs
• Actively participate in interdisciplinary research collaborations with Denali scientists and other leading academic and industrial research groups to advance therapeutic programs through our Discovery pipeline
• Support OTV drug discovery in vitro and in vivo workflows to enable target advancement and platform optimization
• Contribute to the growth and management of our internal oligonucleotide capabilities
• Establish and manage activities at partner Contract-Research Organizations

Successful Candidates Will Meet Most Of These Criteria

• Ph.D. in chemical or protein sciences with ≥4 years of biotech/biopharma experience, or MS with ≥8 years of relevant experience, or BS with ≥12 years of relevant experience
• A deep understanding and demonstrated excellence in solution- and solid-phase oligonucleotide chemistry
• Experience with oligonucleotide-linker chemistry and antibody bioconjugates is a plus
• Knowledge and experience in stage-appropriate QC/analytics relevant to oligonucleotide syntheses
• A record of scientific leadership and innovation as demonstrated by publications and patents
• Strong leadership skills with the ability to plan and achieve research goals in an organizationally diverse research environment
• Strong written and verbal communication skills
• Highly organized with the ability to effectively prioritize individual and group tasks
• Ability to work in a fast-paced environment

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $142,000.00 to $174,333.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

We are currently seeking to recruit a talented Postdoctoral Scientist to join our Lysosomal Function Pathway Team to explore the basic cellular mechanisms of lysosomal dysfunction that contribute to Parkinson’s disease (PD). Reporting to Anastasia Henry (Director/Principal Scientist), the Postdoctoral Scientist will examine the molecular underpinnings of how variants in disease-linked proteins impact lysosomal function and lipid homeostasis and ultimately contribute to disease pathogenesis (as exemplified in Ullman et al STM 2020, Jennings et al STM 2022, and Maloney et al bioRxiv 2022). The Postdoctoral Scientist will employ a cross-functional approach to work toward the ultimate goal of identifying novel potential targets for the treatment of PD.

Responsibilities

• Perform research in a dynamic and collaborative environment
• Collaborate with colleagues across diverse functional areas, including human genetics and functional genomics, to achieve research goals
• Make detailed observations, analyze data, interpret results, and communicate clearly
• Design and implement cellular assays to probe lysosomal function and identify novel regulators, including the use of novel activity-based probes
• Attend conferences, write and publish manuscripts in peer-reviewed journals

Requirements

• Ph.D. in Cell Biology, Biochemistry, Neuroscience, or related fields
• Experience in the field of membrane trafficking or lysosomal biology is highly desired
• Expertise in live-cell imaging and quantitative image analysis
• Proficiency in a broad range of biochemical and cellular techniques including mammalian cell culture and transfection, western blotting, and immunofluorescence
• Highly organized with excellent analytical and critical thinking skills
• Strong oral/written communication skills
• Creative thinker with a strong sense of responsibility and collaborative spirit
• Priority will be given to candidates with no or short (<1 year) prior postdoctoral experience

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary: $80,000 - $80,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

We are looking for an experienced and highly motivated Senior Program Manager for our therapeutic development projects. You will possess science, strategy, and business acumen with the drive to lead teams to develop therapeutics to defeat degeneration.

Responsibilities

• Develop strategy and manage integrated project plans, timeline, risks and costs associated with development of candidate progression through research, pre-clinical and clinical development
• Work hand-in-hand with the Project Leader and Technical Team Leaders to lead drug development project teams, technology platform project teams, and biological pathway project teams, including Core Strategy Teams and Technical Subteams
• Drive effective communication and decision making in a fast-paced environment
• Work with business development in diligence and execution of new collaborations
• Manage and track project metrics including timelines, budgets and risks
• Frame and assess development options based on portfolio context and ensure excellent portfolio management by placing program decisions into the context of the broader pipeline

Basic Qualifications

• Bachelor’s degree
• 4+ years of Biotech industry experience
• 2+ years of direct project management experience in drug development, ideally in early clinical development
• Excellent organizational and analytical skills, keen attention to detail
• Outstanding interpersonal skills to build and maintain strong relationships
• Evidence of strong strategic thinking, analytical, planning and organizational skills

Preferred Qualifications

• PhDin chemistry or biology

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $159,000 to $185,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

In order to support growth, Denali is looking to recruit a Senior Manager for Regulatory CMC. Reporting into the Senior Director of Regulatory CMC, they are responsible for the strategic and technical regulatory leadership of Denali’s portfolio of development programs in neurodegenerative diseases. This role is accountable for continuously evaluating the technical regulatory landscape and providing the team guidance to ensure that Denali development programs meet the CMC requirements of global health authorities.

This role is also accountable for the technical execution of the CMC regulatory strategy and for representing CMC regulatory affairs in cross-functional teams and with external partners. Denali Regulatory Affairs is dedicated to developing innovative regulatory strategies to facilitate development and approval of novel therapies in neurodegenerative diseases. Denali is seeking candidates with a can-do attitude who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven decision making.

Responsibilities

• Supports investigational new drug applications (IND), ex-US clinical trial applications (CTA), marketing applications (NDA/BLA/MAA), and related correspondence from the US Food and Drug Administration (FDA) and other global regulatory authorities.
• Accountable to develop regulatory strategy and lead the implementation and delivery of the regulatory strategy
• Responsible for identifying regulatory risk and mitigation plans
• Independently executes on preparation, submission, and maintenance of CMC Regulatory application components, including routine amendments, annual reports, and correspondence with global Health Authorities
• Participates in cross-functional teams, providing CMC regulatory feedback and support
• Partners with external vendors in support of CMC regulatory document preparation and submission
• Maintains up-to-date knowledge of the regulatory landscape, regulations, and guidelines
• Leads teams in developing, implementing, and delivering the CMC regulatory strategy for development programs
• Accountable for identifying CMC regulatory risk and mitigation plans
• Accountable for managing Health Authority interactions
• Complies with relevant governing laws, regulations, guidelines, and Denali SOPs

Requirements

• Bachelor’s degree required. Advanced degree in life sciences and research experience strongly preferred.
• Experience with small molecule and biologics CMC regulatory development and strategy
• 4+ years or equivalent relevant experience in regulatory affairs
• Broad understanding of international regulations and guidance
• Strong experience in IND and CTA filings. NDA/BLA/MAA filing experience strongly preferred.
• Excellent written and verbal communication skills
• Exceptional influencing, partnership, and collaboration skills
• Strong ability to prioritize workload
• Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners
• Able to prospectively identify potential problems and to partner effectively and positively to solve issues

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $166,000 to $189,667. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali Therapeutics seeks to recruit an Executive Medical Director in late-stage clinical development to provide clinical development leadership in Mucopolysaccharidosis II II (MPS II, Hunter syndrome), a rare condition with neurodevelopmental and systemic disease impacts. The Executive Medical Director will be responsible for the oversight of clinical development program in MPS II. Demonstrated success in conducting registrational clinical trials in rare disease, global regulatory experience including filing for marketing authorization, and cross-functional team leadership experience are critical to success in this role. Full understanding of the relevant compliance framework for clinical development activities, entrepreneurial drive to help the organization succeed, and passion for science and patients are essential.

Responsibilities

• Responsible for the development and execution of a development program in MPS II, including pivotal trials and filing activities
• Collaborate with other Denali clinical, translational, clinical pharmacology, safety, and other technical experts to integrate PK/PD, diagnostic, biomarker and safety plans into the overall clinical development strategy
• Oversee the development and management of study protocols and clinical study reports, study medical monitoring, safety reporting, and clinical-regulatory documents
• Responsible for clinical science aspects of design, execution, interpretation and reporting of efficacy and safety across the clinical trial program
• Provide medical surveillance on Adverse Event (AE), Serious Adverse Event (SAE) reporting, and follow-up
• Partner seamlessly with program management, biometrics, regulatory, clinical operations, development sciences, drug safety, and other development functions to ensure successful development program delivery
• Manage clinical science team members
• Collaborate with academic scientists, clinical experts, and study investigators
• Represent and advocate for the project in internal and external venues
• Act as a champion for high standards of compliance, ethics and safety, and putting patients first

Requirements

• MD or MD-PhD, with formal training in the areas of pediatrics, genetics, and/or neurology preferred
• 7+ years’ industry clinical development experience, preferably in neurological rare disease, including 3+ years’ experience leading cross-functional development teams and management experience
• Demonstrated excellence and experience in late-stage clinical development in neurological indications, including the design, execution, and reporting of pivotal trials and NDA/BLA/MAA filing experience
• Ability to communicate effectively with clinical, biomarker, biostatistical, and pre-clinical scientists, including peer to peer interactions with academic scientific experts
• Track record of excellence in people management
• Demonstrated success in engaging regulatory approval agencies at end of Phase 2, NDA/BLA submission, and drug approval milestones
• Post-marketing clinical development, medical affairs, or drug safety experience is a plus
• This position is based in South San Francisco, CA, and may require travel up to 25% of the time in the future

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $321,000 to $375,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is continuing to build a leading, innovative Biotherapeutic Discovery organization that will strongly contribute to the discovery and development of novel therapeutics for neurodegenerative diseases. We are currently seeking a talented candidate to join our Protein Sciences team to support Denali’s expanding large molecule biotherapeutics efforts with the goal of identifying novel therapeutics for the treatment of neurodegenerative diseases. This position will primarily be at the bench, and the successful candidate will be expected to independently conceive, initiate, and direct protein production and related technology development efforts, in alignment with the goals of the Biotherapeutic Discovery organization. He/she should have experience in all aspects of protein purification, including chromatographic separation by gravity and liquid chromatography methods, all relevant analytics for the quality assessment of purified protein (which may include intact mass spectrometry, ligand binding assessment by SPR or related methods), and ideally also have experience in biochemical assay development, Accordingly, we seek candidates with demonstrated and documented experience in producing and assessing the purity and activity of complex proteins such as engineered antibodies, Fc-fusions and/or bioconjugated therapeutics.

The successful candidate will be responsible for leading the production of large molecule biotherapeutics from milligram to gram scale, including development of robust and scalable purification processes and fit-for-purpose analytics that support the identification and characterization of novel therapeutics. Close collaboration with protein engineers, pharmacologists, biologists & CMC teams will be essential to success.

Responsibilities

• Develop and troubleshoot protein expression and purification processes for large molecule biotherapeutics.
• Evaluate and establish technologies to enhance and/or advance protein production and characterization, including high-throughput approaches, in support of Discovery projects, platforms, and pathways.
• Develop and perform protein purification, biophysical and biochemical characterizations. In this capacity, support and meet timelines for production of a wide variety of proteins, including antibodies, enzymes, Fc-fusions, bioconjugated proteins, and protein complexes.
• Analyze proteins using standard methods (including HPLC, SEC-MALS, CE-SDS, DLS, DSF, MCE and others).
• Coordinate activities and work collaboratively with colleagues across Discovery and Development to meet timelines and to help advance programs.
• Think creatively about ways to integrate novel protein modalities with Denali’s BBB-crossing technologies.
• Actively contribute to project teams and work effectively across functional teams to help advance programs to development.

Successful Candidates Will Meet Most Of These Criteria

• PhD in Biochemistry or related scientific discipline with >5 years of experience in biotech/biopharma industry or M.Sc or B.Sc. with ≥8 or ≥12 years of relevant experience, respectively.
• Extensive knowledge and hands-on experience in the purification and analytical characterization of challenging proteins, complexes and fusion proteins.
• Extensive programming experience of automated liquid handlers and/or protein purification platforms (FPLC/HPLC/robotics).
• Excellent oral, presentation and written communication skills are required.
• Ability to work in a highly dynamic and fast paced environment to contribute to multiple projects.
• Self-motivated with excellent record keeping and written and verbal communication skills.
• Creative thinker with a strong sense of responsibility and a desire to collaborate in an exciting and fast-paced research environment.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $142,000.00 to $174,333.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Reporting to the Chief Commercial Officer, as the Market Access Lead, you will be accountable to provide market access, pricing and health care system dynamics input into Denali’s portfolio including support for business cases as well as the development of the Global brands value proposition in cross functional alignment with Clinical Development, Medical Affairs, and Commercial. Further, the role will develop global market access strategy and tactical plans, define global pricing, establish guidelines for key markets and ensures patient access for a successful product launch. You will be an integral part of the Denali community with high accountability for the effective utilization of resources to meet your strategic objectives, taking into consideration the wider objectives of Denali’s portfolio. You will be a role model as a leader by exhibiting the Denali values.

Core Job Responsibilities

• Leads the development of the global market access strategy and plan for Denali’s product pipeline
• Designs, implements, and manages global/regional access initiatives, incorporating new access algorithms, EAPs and methodologies across key markets.
• Leads the development of Denali’s access systems and capabilities with accurate and integrated data, to enable proactive insights, decision analytics, and forecasting.
• Ramps up Denali’s capabilities in P&R through skills development and training.
• Develops access tools, P&R metrics, pricing reports to upgrade insights to enable strategic decision-making.
• Oversight of market access regulations (pricing, reimbursement, drug listing, payer guidelines, coverage) across key markets
• Maintains a high level of expertise on future trends in healthcare and critical developments in the P&R environment globally and in key markets.
• Defines the Global market access and pricing strategy for new product introductions for multi-country and cross-region product launches
• Effectively manages and collaborates with market access vendors and/or local/regional teams to ensure timely development of market access strategy and execution plan.
• Provides support to Commercial, Medical Affairs and Clinical Development, on all pricing and reimbursement (P&R) related matters.

Requirements

• 10 or more years’ experience in pharmaceutical industry and/or consulting
• Broad-spectrum understanding of key function areas (marketing, payer relations, pricing, health economics, policy)
• Successful track record in market access, strategic planning or portfolio evaluation
• Experience in multiple market archetypes (fully-reimbursed to OOP)
• Experience in a matrix and complex environment is highly desirable
• Experience working in the EU and/or US markets including price negotiations, formulary process and reimbursement dossier submission

Education

B.A. or B.S. in Business Administration or Science; M.B.A or Ph.D. in health policy, health economics or scientific field preferred

Competencies/Skills

• This role will work in teams that are cross-functional in nature – the successful candidate will understand how to engage with people from different backgrounds and levels of exposure to market access
• Strong executive presence and leadership skills including the ability to communicate to key stakeholders (internal and external) clearly and concisely
• Strong written and verbal communication skills required; demonstrated ability to develop compelling presentations / business cases for senior management consumption
• Professional experience demonstrating innovative and “out-of-box” thinking and ability to quickly translate concepts into tangible results and achieve operational excellence
• Winning mentality, “can-do” attitude; innovative, customer-focused, results-driven and pragmatic
• Results oriented entrepreneurial spirit with excellent judgment and the ability to operate as a part of a team
• Impact and Influence - ability to influence teams without direct management
• Experience working cross-functionally; self-starter with a strong sense of personal accountability
• Experience in the following areas is desirable but not necessary: rare disease and/or neurology

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $278,000 to $334,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

We are seeking a Manager in our Financial Planning & Analysis (FP&A) & R&D Finance team. You will play a key role in the preparation of budgets, forecasts, and long-range financial plans.

Responsibilities include leading the consolidation of quarterly forecasts and annual budgets from across the organization, leveraging financial systems to drive efficiencies in FP&A processes, and delivering financial analysis and insights. Additional opportunities for this role will include business partnering & decision support across the product lifecycle. You will have advanced data modeling skills, a strong systems orientation, and the ability to take a proactive approach to new challenges.

Responsibilities

• Provide analytical support to the Finance team including providing financial analysis, consolidation of budgets and forecasts, and reporting expertise.
• Become the subject matter expert for Denali’s financial planning system including administration, generation of reports, and implementation of system enhancements.
• Prepare annual budgets and forecasts for functional departments as well as review of financial performance against targets.
• Partner with Accounting to support quarterly close and accruals. Provide explanations of monthly variances versus expectations and provide insights into business drivers.
• Work cross functionally with business stakeholders, including Clinical Operations, Manufacturing, and other functions to support operational and strategic objectives.
• Develop and maintain various financial templates & models.
• Support preparation of financial updates for Board of Directors & Executive team as needed.

Basic Qualifications

• Bachelor’s Degree (preferably in Accounting, Finance, or related field)
• 5+ years of Finance experience
• Strong Microsoft Excel modeling skills
• Experience with financial planning and ERP systems
• Successful track record leading financial processes, systems, and analytics
• Strong knowledge and experience with accounting principles, financial analysis, and problem solving.
• High attention to detail and solid organizational skills with excellent ability to communicate both visually and verbally.
• Driven to success and willingness to do what it takes to get the job done well in a highly dynamic environment. Self-motivated, independent and results oriented.

Preferred Qualifications

• MBA, CFA or CPA
• Good knowledge of GAAP and Accounting guidelines
• Life science / pharma / biotech experience

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Salary Range: $138,000- $171,000 Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

In anticipation of the Company’s growth plans, Denali Therapeutics is seeking a Vice President of Global Medical Affairs. This is a key leadership role that will shape the future direction and growth of Medical Affairs at Denali. The Vice President, Global Medical Affairs will oversee the successful development of medical strategy and execution of medical activities for investigational neuroscience and rare disease programs within the clinical development portfolio . The successful candidate will ensure appropriate processes, staff, and systems are in place to enable high quality medical evidence generation and medical communication according to industry standards and global regulations.

We are seeking a transcendent leader who has a stellar medical science background; is a collaborative self-starter who thrives in a matrixed environment; and has demonstrated leadership excellence in building a medical affairs organization and providing oversight for global medical affairs teams across the product lifecycle.

Responsibilities

• The Vice President of Global Medical Affairs will continue to build and oversee a capable Global Medical Affairs organization in order to maximize the success of Denali’s advancing clinical portfolio
• Overall responsibility for Medical Affairs associated activities including medical and health economic evidence generation, strategic publication planning, medical and scientific advisory boards, educational programs, responding to requests for medical information, and field medical
• Oversee Medical Affairs teams’ contributions to strategic project plans, including the integrated product strategy, integrated evidence plan, global conference strategy, patient advocacy engagement plans, future launch planning, and other key program deliverables across the product lifecycle
• Responsible for the development and delivery of accurate and fair-balanced clinical and scientific information to healthcare professionals, both proactively and in response to requests for information, in accordance with promotional compliance and regulatory requirements in a global setting
• Build a Medical Information infrastructure to respond to external requests for information regarding investigational compounds
• Responsible for the successful dissemination of innovative clinical information to thought leaders, payers, and other key external stakeholders; foster medical and scientific information exchange with specific disease area communities
• Represent Denali science externally with the highest standards of evidentiary rigor and scientific credibility
• Collaborate with internal stakeholders to ensure timely, accurate and compliant preparation and review of promotional and educational material
• Partner with Denali teams and leadership across the organization including, but not limited to, Discovery, Development, Regulatory, Commercial, Legal, and Investor/Corporate Relations functions
• Prepare and maintain departmental policies and SOPs to ensure compliant dissemination of medical information to and engagement with global medical audiences
• Establish Medical Affairs departmental goals, and identify and direct appropriate resources to ensure their success
• Participate in the development and management of departmental budget
• Ensure appropriate training of medical affairs personnel based in corporate offices in South San Francisco and Zurich, Switzerland, as well as field locations
• Hire and retain top talent

Requirements

• Board Certified physician (MD, MBBS, DO) with 12-15+ years of medical affairs experience in the biopharmaceutical industry in both pre-launch and post-marketing settings
• A minimum of 8 years in Medical Affairs leadership positions including project and line management experience overseeing multidisciplinary medical affairs staff and vendors; prior experience in a Vice President/Head of Medical Affairs role highly preferred
• Demonstrated ability to build, develop, and motivate teams with a track record of effective hiring, coaching, and mentoring of direct reports
• Expert proficiency in design methodology, conduct, analysis, and interpretation of randomized clinical trials and observational studies
• Track record of excellence in guiding teams to assimilate, synthesize and effectively communicate clinical data for varied audiences
• Strategic agility to flex to evolving business priorities, identify new strategic opportunities, and adapt short-term plans
• Ability to thrive in a fast-paced, results-oriented entrepreneurial environment; willing to work hands-on and with a sense of urgency
• Strong customer focus
• Strong working knowledge of global medical affairs compliance requirements
• The position is located in South San Francisco, CA, and may require up to 20% of time traveling

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state or local protected class.

Salary Range: $345,000 to $390,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

• This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.