Longevity Industry Jobs

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer . Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

If autonomy and collaboration in tackling challenges are what you are seeking and would like to be part of a hardworking team where everyone has a voice, join our mission!

As Senior Clinical Programming Manager, you will be responsible for developing program specifications, programming listings and reports, and providing other clinical programming support for assigned studies. The position requires a broad, comprehensive, and detailed knowledge of programming languages and software, filing requirements, clinical trial databases, and pharmaceutical drug development process. You will lead a group of programmers who develop programs that generate a variety of reports to facilitate the review of clinical data & validate such programs, write general SAS application codes, prepare documentation, and explore new technologies to improve quality and efficiency of analytical programming group.

You will work closely with the Head of Clinical Programming to assign resources for various projects based on priorities and develop business relationships internally and externally. You will also contribute to departmental process and standards initiatives such as DRP (Data Review Package). It is imperative that as the Senior Clinical Programming Manager, you have the ability to influence key decision makers within the project team and within senior management to ensure a high degree of rigor to the statistical and scientific decision-making process and outcomes.

Do you want to apply your existing technical skills, join a hardworking team and learn and implement new capabilities? Can you see yourself playing a key role in clinical development and trial design for our antibody therapeutics? If so, we want to hear from you.

During your first year, your goals will include:

• Lead clinical programming timelines on all molecules & studies to coordinate and synchronize deliverables with the overall study timelines.
• Partner with Clinical Data Management to Implement CDISC using CDASH guidelines and standard methodologies to facilitate creation of SDTM and ADaM compliant datasets.
• Create Metric/Status Reports [i.e., Coding Metrics, Drug Dispensation Metrics, Subject Status Reports, BOXI Reports for Medidata Rave Studies] based on study specific requirements.
• Create or lead development of Clinical Data Review Tools, External Data Reconciliation Listings, Medical Safety Listings for reconciliation for all Alector studies] based on study specific requirements.
• Create Lab, Pharmacokinetics(PK) and Pharmacodynamics(PD) reconciliation reports.
• Participate in study meetings with Clinical science, Clinical operations, Data management, Safety, and Statistical teams to create specifications and develop reports.
• Program / generate ad-hoc reports and listings for Study Management Team (i.e., medical monitors etc.), regulatory submissions and inspections.
• Responsible for partnering with CDM to develop data transfer specifications, processing of clinical data downloads, and data transfers to/from service providers and within Alector.
• Verify SAS programs for Clinical data review listings, Metrics, and reconciliation reports following the departmental verification procedures.
• Create DOS/UNIX/Powershell batch scripts to schedule SAS jobs and distribute the reports.
• Responsible for medical coding data transfers (MedDRA and WHODrug) to/from Centralized Coding vendor for processing and creating coding reports to support the Alector Coding process.
• Importing and extracting data by connecting SAS System to database systems such as Microsoft SQL, Excel, and exporting data to generate dynamic reports in HTML, RTF, XML, Excel, and PDF formats by using SAS/ODS.

We'd love to hear from you if you have:

• Bachelor’s degree in any Science field.
• A minimum of 10+ years of data management and analysis using SAS programming language in the pharmaceutical or biotechnology industry.
• Prior neuroscience & oncology/hematology experience is highly desirable.
• Dynamic self-starter; agile learner; strategic and creative problem solver.
• Proven strong decision-making and risk-mitigation skills.
• Requires proven knowledge of clinical programming principles, clinical trials process, and regulatory requirements
• Excellent verbal/written and interpersonal skills are required for working successfully in a cross-functional team environment
• Able to communicate and collaborate effectively with cross-functional teams
• Solid understanding of ICH, FDA, and GCP regulations and guidelines
• Strong well-rounded technical skills (SAS, EDC systems, MS Word, Excel, PowerPoint, API based data extracts, ETL principles) and knowledge of industry standards (CDISC, SDTM, CDASH, ADaM)
• Prior experience working with data visualization software such as Spotfire, Tableau, and Saama is desirable.
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems, and industry-wide thesauri, such as MedDRA.
• Proven track record to work both independently and in a team setting in a leadership role.

Salary Range:

$174,000 - $188,000 a year

Base salary ranges will be determined by the candidate’s level, qualifications, skill set, and experience.

Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune’s " Best Workplaces in Biopharma " top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022.

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer . Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

Please join us in driving the development of new therapies that seek to transform patients' lives. If autonomy and collaboration in tackling challenges are what you are seeking and would like to be part of a hardworking team where everyone has a voice, please join our mission!

As the Director Biostatistics you will provide statistical leadership and expertise supporting the clinical development activities for multiple therapeutic areas. You will be responsible to provide statistics and contribute strategically to project decisions. You are expected to apply innovative statistical approaches to the work (e.g, modeling and simulation, adaptive design/Bayesian statistics); support and defend analyses and their interpretations in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions.

The director will partner with project teams and other functions which include statistical programming, data management, medical affairs, clinical science, clinical operations, medical writing, and regulatory personnel. You will influence key decision-makers within the project team and senior management to ensure a high degree of rigor in the statistical and scientific decision-making process and outcomes.

Do you want to apply your existing technical skills, join an hardworking team and learn and implement new capabilities? Can you see yourself playing a key role in clinical development and trial design for our antibody therapeutics? If so, we want to hear from you.

During your first year, your responsibilities and goals will include:

• Define how you will contribute to Alector's overall 3-5 year vision to continually improve our clinical development strategy
• Collaborate with internal and external stakeholders in the optimized clinical study design, endpoint selection and sample size calculations, analysis, interpretation, and publication of clinical trial data
• Execute protocols, statistical analysis plans, and study reports, ensure statistical integrity of presentations and publications of clinical studies
• Support the project and clinical study teams including but not limited to the derivation of go/no-go criteria, generation of data visualizations and summary reports, and interpretation of results to support internal decision-making
• Participate in regulatory interactions (IND/CTA filings, annual safety reporting) and responsible for biostatistics input into study protocols and clinical study reports
• Review study randomization specifications, oversee outsourced development of analysis data and results; and review case report forms while managing workflow to ensure quality, prioritization, and timeliness across multiple programs
• Manage external vendors and serve as a key Biostats liaison with external organizations
• Participate in establishing and maintaining policies, standards, and guidance for Biostatistical operations
• Lead Biometrics & Digital Science Department Initiatives
• Ensure up to date knowledge of industry and academic developments in the Neuroscience, Immuno-Oncology, and Orphan disease fields and apply to clinical study design and analysis

We'd love to hear from you if you have:

• PhD with 8-10 years, or MS with 10-12 years of proven experience in academia or industry. Pharmaceutical/biotech industry experience preferred
• Strong knowledge of theoretical and applied statistics
• Experience with multivariate statistics and statistical methods to quantify uncertainty in multi-dimensional data; experience running simulations and mixed models
• Hands-on ability to drive and lead statistical strategies for clinical development of drug candidates from first-in-human testing to all later phases of clinical investigation, including pivotal Phase 2/3 studies and NDA/BLA submissions
• Demonstrated success in leading the statistical strategy, analysis and design of a clinical development program
• Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
• Advanced programming skills in SAS and/or R and other relevant statistical software solutions.
• Ability to code programs to analyze and report complex clinical trial data, as well as for electronic review, exchange, transformation, and submission of data in CDlSC, SDTM and ADaM formats
• Strong application of innovative study designs and developing landmark criteria (e.g. Go/No Go criteria).
• Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and data modeling is strongly preferred

Salary Range:

$240,000 - $259,000 a year

Base salary ranges will be determined by the candidate’s level, qualifications, skill set, and experience.

Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune’s " Best Workplaces in Biopharma " top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022.

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

We are seeking a highly motivated individual to join us as Senior Technical Operations Director at our South San Francisco location. The successful candidate will work cross-functionally to lead drug substance and drug product development and manufacturing efforts for numerous programs across a global contractor network. The candidate will be a key contributor to project teams and lead the BLA enabling CMC activities to support commercialization of lead candidates.

The position will report directly to the Head of Technical Operations.

During the first year, your responsibilities and goals will include:

• Drive pharmaceutical development activities for drug substance, drug product, and clinical trial materials throughout development
• Continuously assess and communicate the manufacturing status for multiple programs across a global CDMO network
• Develop and manage the BLA enabling CMC activities for lead clinical programs
• Manage internal and external interactions with quality and regulatory organizations to ensure the timely resolution of technical issues
• Author regulatory submissions to planning and respond to technical queries received from global health authorities
• Assess CMO and supplier performance to plan while also developing phase appropriate contingency strategies
• Represent CMC operations across internal and external project teams
• Grow partner relationships for co-developed programs and support partnering due diligence efforts for preclinical to clinical assets
• Identify and assess new technologies and contractors to support manufacturing requirements

We'd love to hear from you if you have the following:

• Bachelors degree in biological sciences or related field with minimum of 15 years demonstrated experience in a pharmaceutical setting. Advanced degree is preferred (MS/PhD)
• Hands-on experience with large molecule drug substance and drug product manufacturing processes, as well as clinical packaging and distribution
• Demonstrated a track record of building relationships with vendors, suppliers, and contract organizations effectively
• Ability to deliver in a fast-paced, small company environment and the tenacity to seamlessly adjust workload based upon changing priorities
• Ability to mentor and lead both directly and through influence
• Excellent communication skills, including the ability to influence cross-functionally and articulate complex issues clearly to drive understanding and decision-making
• Experience developing and managing projects and budgets to plan
• Thrive in an environment where work is accomplished both independently and by teams
• Understanding of ICH, FDA, and USP guidelines in phase-appropriate pharmaceutical development
• Outstanding ethics and integrity

Salary Range:

$156,000 - $168,000 a year

Base salary ranges will be determined by the candidate’s level, qualifications, skill set, and experience.

Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune’s " Best Workplaces in Biopharma " top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022.

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer . Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

As a research manager in the In vivo Pharmacology team, you’ll work closely with scientists in research and development, supporting ongoing programs at the early discovery phase. Your contribution will be crucial for the generation of an innovative therapeutic approach targeting myeloid cells in neurodegenerative disease. You will be involved across a variety of projects in work central to Alector’s strategic mission. While applying your existing skills, you will also expand your expertise to new technologies and play a key role in the pre-clinical development of our programs. As a new hire, you will help grow the company, guide its direction, and, above all, bolster Alector’s culture of thinking independently and working on teams.

During your first year, your goals and responsibilities will include:

• Work with Research teams and outside collaborators to identify and obtain animal models, or with geneticists in creating animal models of human disease
• Coordinate with internal research teams to provide timelines and resource availability projections in support of early-stage research and non-clinical activities
• Collaborate with various internal legal and business groups to establish contracts and ensure payments
• Coordinate and lead vivarium operations including people management (lab technicians), administrative support, animal husbandry, and technical support for research activities
• Develop and maintain vivarium SOPs, policies, and guidelines in compliance with animal care and use protocol, and IACUC guidance
• Lead and/or support the execution of in-house studies. Proficient in small animal handling and dosing of test agents via various routes (IV, SC, IP PO) and other CNS delivery routes

We'd love to hear from you if you have:

• B.A. with 5-10 years of scientific experience in the biopharmaceutical industry. Degree in Pharmacology, Immunology, Neuroscience, or a related field. MS or Ph.D. preferred
• Experience running a research animal facility
• Track record of managing, developing, and mentoring junior research technicians
• Experience in the management and tracking of rodent colonies
• Experience in the design and production of mutant mouse models of human disease
• Hands-on experience in handling, dosing, blood sampling, and tissue harvest in rodents is a plus
• Ability to easily work on several projects simultaneously

Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune’s " Best Workplaces in Biopharma " top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022.

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range: $153,000 - $165,000 a year

Base salary ranges will be determined by the candidate's level, qualifications, skill set, and experience.

• Scout and optimize purification steps for yield, product quality, reduction of impurities, and loading conditions
• Perform robustness testing of chromatography unit operations and scale-up purification processes.
• Conduct hold-stability studies of intermediate eluate product pools Design and implement formulation studies, including short and long-term hold stability studies of formulated proteins
• Mentor junior research associates in process development best-practices
• Evaluate new technologies (e.g. automation, novel resins and membranes, etc.) to further enhance internal process development capabilities
• Lead a team in the manufacture, proper documenting, and final filling of larger-scale Drug Substance batches for Non-GLP tox studies
• Author, review, and edit documents related to downstream processes, such as SOPs, batch records, and development reports

• PhD in relevant scientific fields with 2-5 years OR a B.S degree with at least 8 years of increasing responsibility, relevant proven experience
• Hands-on experience developing, optimizing, and scaling-up purification process unit operations for various chromatography methods using AKTA FPLC systems
• Familiar with Unicorn software and able to author and customize purification methods for various techniques
• Possess technical mastery of industry-standard chromatography techniques and methods for the purification of antibodies like: Protein A affinity chromatography, IEX chromatography, membrane chromatography, HIC chromatography, mixed mode chromatography, and TFF formulation unit operations
• Experience in design of experiments (DOE) for purification optimization is highly desirable
• Extensive experience purifying monoclonal antibodies and highly desirable if candidate has familiarity with fusion proteins, tagged proteins, and bi-specific molecules
• Strong organization skills in recording and summarizing data with strong attention to detail
• Must possess the ability to multitask and prioritize work to support organizational needs and meet deadlines in a fast-paced environment
• Ability to design, execute and analyze experiments and problem-solve independently
• Excellent communication skills to work collaboratively in a team environment

• Experience with basic analytical assays (e.g. SDS-PAGE, SEC-HPLC, UV-Vis, LAL), liquid protein formulation development, and large-scale purification.

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer . Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

As the Senior Director, Biomarker Discovery and Development, reporting to our President, Head of R&D, you will be responsible for the scientific, strategic, and managerial leadership of the team of scientists, and will be accountable for all biomarker discovery and development deliverables. This group provides biomarker and translational science support to inform the clinical development of Alector’s programs across neurodegeneration and oncology. Our biomarker strategies are developed for all stages in the drug development path starting from the research discovery phase all the way through approval of the drug. We focus on pharmacodynamic and disease biomarkers as well as patient selection markers to enable our vision of “the right drug for the right patient at the right dose”. In this capacity

You’ll closely collaborate with research biologists, assay development scientists, clinical scientists, biostatisticians, regulatory, clinical operations, and project team leaders. You’ll also work closely with Research to ensure biomarker discovery is taking place early in the molecule interrogation process. You are accountable for ensuring that appropriate biomarker strategies are developed using state-of-the-art technologies that novel biomarkers are discovered in the research and preclinical stages of the projects from literature, and are fully integrated into clinical plans allowing for informed decision making in our clinical studies.

At Alector, we have a broad portfolio of programs in the clinic and in discovery research. This position will be critical in setting the strategy to move these programs forward as efficiently as possible. You will apply your existing technical skills, learn new skills, and play a key role in bringing ground-breaking therapies to our patients.

During the first year, your responsibilities and goals will include:

• Develop and execute an innovative translational and biomarker strategy working across the pipeline, from early discovery through clinical studies
• Lead team of scientists responsible for biomarker strategies for the entire portfolio
• Lead the design, development, timeline management, and execution of:
• Biomarker discovery efforts
• Clinical biomarker strategies
• Biomarker assay implementation in clinical studies
• Biomarker sections of regulatory documents, eg clinical protocols, INDs, investigator brochures, other external presentations, information and materials
• Translational studies bridging research and biomarker questions in clinical trials
• Reverse translation approaches using biomarker and other data from clinical trials
• Review materials and are subject matter expert on various internal committees (e.g., DRC) regarding biomarker strategies, priorities, implementation, or data analyses.
• Provide direct reports with ongoing mentorship, development and leadership.
• Stay abreast of internal and external developments, trends and other dynamics relevant to the work of Alector to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).
• Design and oversee the use of biomarkers in clinical studies, writing protocols for incorporation of biomarkers in clinical trials, training trial sites, or clinical CROs to ensure protocols are followed, overseeing the analysis of markers in clinical samples, and preparing reports suitable for regulatory documents.
• Collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists, and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups across Alector.
• Play a leadership role in ongoing improvements/development of team processes, structures, systems, tools, and other resources.
• Collaborate with the regulatory and clinical teams to develop accelerated approval strategies based on biomarker endpoints.

We'd love to hear from you if you have:

• A PhD degree or MD/PhD in a relevant scientific field - e.g. immunology, neuroscience, molecular biology, cancer biology, with deep experience and exposure to the discovery and development of biomarkers, either in a research or clinical setting.
• Proven experience in the neuroscience therapeutic area and/or oncology is required.
• 12-15 years of experience in drug development and translational research including discovery, development, and utilization of biomarkers and their associated technologies in an academic and/or industry setting.
• A minimum of 10 years of experience managing a team.
• Strong collaboration skills
• Requires deep knowledge base and experience in translational science, interpreting and analyzing scientific data with solid judgment skills in application and relevance in the clinical setting.
• Extensive experience in areas of basic research as well as translational science and clinical development
• Broad experience in the principles and techniques of discovery, data analysis, interpretation, and clinical relevance.
• Strong scientific skills in translational biology
• Excellent communication skills and the ability to work on interdepartmental project teams and on external collaborations.
• Take pride in your individual contributions, your decision-making acumen, and your ability to work well with, cross-functionally influence, and lead others.

Salary Range:

$288,000 - $311,000 a year

Base salary ranges will be determined by the candidate's level, qualifications, skill set, and experience.

Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune’s " Best Workplaces in Biopharma " top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022.

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

• Maintain mammalian cell culture in static and shake cultures and all tasks related to mammalian cell culture which will include preparing media and feeds
• Transient production of recombinant proteins and antibodies, including planning, transfection, harvest, and titer assays.
• Stable cell line development from transfection to clone stability.
• Perform high throughput cloning and screening of clones
• Develop an experimental plan and be able to execute cell culture studies in the laboratory
• Perform routine laboratory operations such as seed culture expansion in shake flasks and bioreactors, production cultures in shake flasks, wave bag, and single-use bioreactors, product harvest, routine in-process analytical testing, etc.
• Support process optimization and process characterization work to develop scalable and manufacturing-friendly processes
• Experience with ambr systems preferred

• BS in Biology, Biochemistry, or Chemical/Biochemical engineering or in a related life-sciences field
• Minimum 3 years of experience in cell culture/fermentation process development and/or manufacturing sciences supporting cell culture operation in the biopharmaceutical/biotechnology industry.
• Minimum 1 year of hands-on experience in process scale-up or operation of large-scale bioreactors and cell culture equipment.
• Excellent aseptic technique is a must
• Team player, with no task too small attitude
• Willingness to learn

• Provide leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology disease areas with knowledge from the medical community around the world.
• Integrate the scientific rationale, regulatory and payor requirements, input and advice from medical and patient advocacy groups, product development plan, and commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP).
• Act as Sponsor Medical Monitor with oversight of clinical trial activities and patients safety on behalf of the Clinical Science Group at Alector.
• Establish aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP.
• Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Biomarkers, Clinical Operations, and Statistics.
• Establish external collaborative relationships to augment Alector’s capabilities in support of the clinical development programs.
• Participate in clinical reviews of the safety of Alector programs.
• Contribute to the development of critical initiatives and specified Business Development activities. 

• 5+ years of experience in clinical research
• Proven experience in clinical development preferred, but not strictly required
• Deep understanding of basic science related to neurodegeneration and immunology
• Capacity and willingness to work effectively across disease areas.
• Demonstrated leadership and team-building skills as well as being able to perform effectively in a dynamic environment.
• Demonstrated strategic and critical thinking.
• Excellent communication and organizational skills.
• The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills. 

• MD, MD / PhD or DO credentials. Neurology training with subspecialization degenerative CNS disorders preferred.

• Develop, coordinate, and execute our biomarker strategies for our preclinical and clinical molecules
• Serve as the Biomarker Lead in a cross-functional team to implement impactful biomarkers into our projects and perform data analysis
• Collaborate closely with research teams on the discovery of novel neuroscience biomarkers
• Manage data workstream, deliverables, timelines, and communication with internal and external partners

• Ph.D. or equivalent in Neuroscience, Immunology, or related discipline with 5-8 years of post-doctoral experience or MA/MS with 10 years relevant experience, industrial experience preferred.
• Proven experience in Alzheimer’s Disease preferred
• A record of high-quality research as proven by publications in top-tier journals, external presentations, or drug development reports is required
• Analytics skills such as R, Python, or other data analysis programming
• Excellent communication and writing skills and thrive in an environment where we work independently and on cross-functional teams
• A track record of learning new skills and troubleshooting independently and take pride in being persistent, self-motivated, and efficient
• Experience in drug-development
• Great attention to detail and operational management skills
• A high level of independence and be able to develop hypotheses and direct analysis plans 

• Prepare/Review month-end clinical, R&D accruals analysis, including review of CRO reports, patient costs and sites accruals.
• Prepare corresponding monthly journal entries and related supporting documentation.
• Prepare / Review monthly and quarterly accounts reconciliations (clinical and related prepaids).
• Review contracts and amendments monthly and analyze/determine impact on clinical accruals.
• Maintain proper documentation and internal controls around clinical trials accounting for SOX compliance.
• Work cross functionally with Clin Ops, Manufacturing, Research and Legal and other various business owners as well as external consultants.
• Work with external CROs and clinical /manufacturing vendors to ensure that accruals are accurately accounted for.
• Assist with preparation of audit schedules and other support requested by the internal and external auditors.
• Provide support as needs arise for special projects, system improvements, or ad-hoc financial requests. 

• BS or BA in Accounting or related field
• CPA or equivalent highly preferred
• Big 4 audit experience a plus
• 3+ years Biotech experience, specifically clinical trial accounting
• Proficiency in Excel
• Knowledge/Experience with NetSuite and Coupa is a plus
• Strong working knowledge of system processes, internal controls, US GAAP
• Sarbanes Oxley (SOX) compliance experience
• Detailed oriented and ability to work independently with limited supervision
• Excellent written and verbal communication and interpersonal skills

• Collaborate with senior leadership to provide strategic and technical leadership of Quality Assurance activities and outcomes. You'll lead a culture of Quality by conceiving, collaborating, and supporting the implementation of specific actions, processes, and behaviors.
• Help to implement, monitor, and promote good practice of all Quality Assurance Systems to ensure compliance with relevant FDA and EU regulations/directives/requirements and ICH guidelines.
• Establish required phase-appropriate GxP systems for Alector, including prioritization, and timeline oversight.
• Evolve, audit, and monitor Standard Operating Procedures (SOPs) and Work Practices (WPs) to ensure they are in accordance with GCP and GLP guidelines and meet local regulatory requirements. Carry out corrective actions for identified deviations.
• Be responsible for CQA validation and audit of computer systems in support of research, development, global operations, and global pharmacovigilance.
• Partners with research staff in study design, data collection, and analysis, reporting activities that support quality improvement interventions, transparency, compliance with regulatory standards, and provide performance monitoring.
• In coordination with the SVP and peers within the Global Quality organization, develop and implement a common platform of quality and compliance systems, tools, procedures, and standards.
• Work to develop a quality CMC strategy via objectives and plans to ensure quality oversight, timely resolution of issues, and early intervention to assure compliance.
• Review Validation Master Plans and protocols for CMOs to implement in order to ensure requirements for BLA filings are met.
• Direct and mentor a team of dedicated and exceptional Quality Assurance professionals.
• Accountable for training and education on GxPs, SOPs, and WPs.
• Accountable for the preparation and conduct of all inspections by any regulatory authority.
• Serve on Joint Steering Committees for Alector in partnerships with CDMOs and CROs.

• Minimum 15 years of experience in the biotechnology industry with at least 10 years in Quality, and at least 7 years in a leadership role.
• Bachelor's degree in a scientific field or relatable field required; Master's or Ph.D. strongly desired.
• Track record of establishing Quality systems in a phase-appropriate manner.
• Proven success with establishing a strong Clinical QA team.
• Experience with cGMP requirements for Phase III and commercial products and with US and International regulatory authority inspection requirements and first-hand experience hosting pre-approval inspections.
• Success in collaborating on IND, BLA/NDA, and MAA submissions for novel products.

• Performing innovative bench work such as genetic engineering of diverse cell types using CRISPR, preparing lentivirus and developing functional assays for new and existing targets
• Generating primary data and communicating analyses verbally and in writing to teammates

• You have extensive tissue culture experience with both cell lines and primary cells
• You possess skills of basic molecular biology techniques including nucleic acid purification and quantification, PCR, cloning and gel electrophoresis
• You have proven your ability to plan, organize and implement studies independently with a large number of samples
• You take pride in being persistent, self-motivated, efficient and extremely well organized
• You thrive in an environment where we work independently and on teams
• You demonstrate a track record of learning new things and troubleshooting independently
• You have at least 3 years of research experience at the bench in a relevant field
• You have a point of view but are low ego

• You regularly prepare lentivirus and transduce diverse cell types
• You have experience preparing and performing QC on NGS libraries for RNA-seq
• You have experience with FACS and/or plate-based assays
• You have direct experience working with microglia and/or iPS cells
• You have a working knowledge of CRISPR-based technologies (CRISPRi/a)

• Use your experience to timely draft, review and negotiate agreements, including Master Services Agreements, Laboratory Agreements, Statements of Work, Consulting Agreements, and Confidentiality Agreements, escalating to manager and others as needed
• Manage a high volume of agreements from start to finish to support scientific and operational needs of the company
• Develop collaborative working relationships with cross-functional partners
• Operate and support our existing contracting policies and processes and assist in the development and implementation of process improvements
• Play an important role in the design, development, and implementation of a contract management system
• Contribute to the development of contracting playbooks and templates
• Develop training on contracting policies and processes or contract issues for the company
• Serve as primary point of contact for business stakeholders on contract matters
• Assist on other projects and supporting administrative functions as needed as part of the legal team

• BA in a relevant discipline. JD from an accredited law school or paralegal certificate (or equivalent degree or experience) is preferred.
• At least three (3) years experience in pharmaceutical/biotech industry contracting
• Familiarity with biopharma industry, from drug discovery to clinical development
• Ability to identify contract-related risks and issues and propose solutions and mitigations
• Strong drafting and negotiating skills, with the ability to work with or without a playbook
• Excellent time management and prioritization skills, with the ability to manage multiple projects at once
• Adaptability to new and evolving processes
• Ability to work independently or as part of a team
• Excellent business judgment
• Strong communication and social skills, both oral and written.

• Analyze current scientific literature to help identify new targets or new strategies for existing targets
• Develop novel functional assays to evaluate lead drug candidates
• Collaborate internally with cross functional teams, and with external academic partners and contract research organizations to ensure successful outcomes
• Present results at project team meetings, group meetings, and company meetings
• Improve group capabilities by identifying and implementing new technologies

• A PhD in immunology or related field, with postdoctoral or industry experience (preferred) OR a MS and 10 years relevant industry experience
• Up-to-date knowledge in the field of immunology and cancer. Prior experience with lymphoid cell biology a plus.
• Experience with drug development in an industry setting
• Proficiency with immune pathways and an understanding of methods to interrogate these pathways
• Technical expertise in multi-color flow cytometry, in vitro primary cell culture, cell signaling, immune phenotyping, and data analysis to support target validation
• Excellent written and oral communication skills

• Provide strategic direction and lead staff in the design, and execution of the Clinical Science function.
• Provide scientific input to translational studies, clinical development programs, and definition of efficacy and safety endpoints for Phase I, II, and III clinical trials.
• Collaborate with the Medical Monitors and Pharmacovigilance team on medical and safety monitoring, and the review, analysis, and interpretation of study results, including exploratory endpoints, and assure appropriate data review and accurate data reporting.
• Act as Lead clinical development person for studies and collaborate closely with the Study Leader to assure efficient study execution and accurate study conduct.
• Prepare and interpret data and contribute to scientific publications including posters, abstracts, and manuscripts.
• Provide support to advisory boards, consultant meetings, and investigator meetings, including preparation and delivery of presentations.
• Collaborate with Clinical Outcome Assessment (COA) vendors, Imaging vendors, and specialty vendors during study startup and during study execution to enable quality study assessments and troubleshoot issues.
• Provide input and collaborate across all functional areas, including research, non-clinical, biomarkers, clinical pharmacology, clinical operations, project management, biostatics, data management, and regulatory affairs departments.
• Represent the company at investigators' meetings.
• Co-author relevant sections of clinical documents and publications pertaining to translational biomarkers (e.g., Clinical Protocols, Informed Consent, Clinical Study Reports, Investigator Brochures, abstracts, and manuscripts) and documentation for submission to regulatory agencies.
• Direct medical writing and study team in the development of Clinical Protocols, Investigator Brochures, and other documents owned by the Clinical Science function.

• Ph.D. in a relevant scientific area with 8+ years of industry experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.
• Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in the design of study protocols is required.
• Direct experience coordinating trial activities, in clinical sample management and biomarker analysis.
• Proven scientific leadership when working with collaborative, multi-functional teams.
• Excellent technical writing and communication skills; able to articulate sophisticated scientific concepts to diverse functional groups and external partners.
• Proven experience authoring submissions documents to regulatory agencies.
• Knowledge of clinical outcome assessments (COAs) and experience working with COA / Rater vendors highly desirable
• A history of strong collaboration and personal interaction with all levels of internal partners including, Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, Non-clinical Science, and Product Development.
• Highest level of scientific integrity.
• Strong digital literacy including MS Office (Word, Excel)

• Lead all aspects of the receipt and filing of electronic and paper clinical trial TMF documentation
• Lead the archival, tracking, and retrieval processes for completed TMFs stored on or off site
• Maintain the TMF Index/Table of Contents
• Support eTMF system administration, implementation, and maintenance
• Responsible for training and presenting with user groups and information technology staff supporting TMF processes
• Build and maintain a database of all documents, paper or electronic, including the exact location
• Lead document review requests and resolve documentation issues
• Participate in Study and Project Team Meetings as the need arises
• Lead the clinical document control efforts in preparing for and participating in an audit and/or regulatory inspection
• Support internal and external audits including the development and implementation of CAPA results activities
• Lead the management of the life cycle of clinical study records, including retention and disposition of records and associated audit trails in accordance with the best business practices and corporate policies and procedures

• Proven solid understanding of GCP, ICH guidelines and global regulations
• Demonstrated solid understanding of Trial Master File requirements and set up
• Experience managing electronic document management systems and document archival systems (eTMF)
• Experience with clinical trial registry regulations, submissions, and management
• Demonstrated ability to work independently and in a team environment

• Independently execute bioinformatics analyses that support discovery and pre-clinical studies (RNAseq, scRNAseq, proteomics, lipidomic).
• Identify relevant internal and external data and knowledge resources and execute integrated data mining analyses.
• Applying existing computational methods and develop new ways to analyze and understand large, multimodal, and complex datasets.
• Keep track of the current analytical methodologies and introduce them when appropriate.
• Communicate analysis results verbally and in writing to teammates.
• Actively participate in diverse teams by providing expert opinion and mentorship.
• Take an active part in setting the group strategy and goals

• Your academic background includes a PhD with 1 -3 years of relevant experience (including in industry).
• Extensive experience in the use of a high-level programming language such as R (preferred) or Python for statistics and computational biology
• You have hands-on experience in genomics and genetic databases, in data analyses using existing and custom pipelines.
• You have used or developed new computational methods to answer biological questions.
• You are fluent in R/Python, have experience with GitHub and cloud computing (AWS)
• You have experience in performing statistical analysis
• You take pride in being persistent, self-motivated, and efficient.
• You thrive in an environment where we work independently and on teams
• You demonstrate a track record of learning new things and troubleshooting independently.
• Excellent communication skills
• You have a point of view but are low ego

• Work with the CFO and executive team to develop and implement a comprehensive, best-in-class IR program that aligns with company strategy and leverages a strong understanding of the investment, biotech, and pharmaceutical communities to enhance the perception and visibility of Alector
• Collaborate with various functions within Alector, including the executive team, clinical science, medical affairs, regulatory, corporate communication, finance, business development and legal teams to develop consistent messaging and flow across all external collateral materials
• Manage interactions and communications with existing and potential shareholders and sell-side analysts; be responsive to information needs in compliance with company policies and securities regulations
• Collaborate with company leadership to advance engagement with sell-side analysts, with the goal of supporting coverage that recognizes the portfolio value and aligns with the corporate growth trajectory
• Gather real-time insights and analysis from analyst reports, shareholder filings, investment sentiment, and competitor activity, and effectively prepare Alector leadership team/other internal stakeholders for external interactions
• Share market intelligence and investor perceptions of the company’s performance, and make sure investors are represented as a key stakeholder in the formation/execution of program strategy and communications
• Partner with legal to develop securities filings/other disclosures and ensure compliance with company policies and securities regulations
• Oversee ongoing analysis of shareholder base and refinement of investor targeting strategy
• Assist in development of strategic communications directed to the investment community related to corporate and product milestones, quarterly financial results, annual report, and other disclosures, including press releases, conference call scripts, slides, and Q&A
• Direct the IR section of corporate website including managing core messaging and updates to the company corporate presentation
• Manage investor relations firm and assist in external media relations
• Help organize, plan, attend and track company road shows, presentations, speaking engagements, and conferences
• Serve as primary contact and resource for fielding investor calls, requests for information, and shareholder questions
• Manage other third-party vendors and resources

• BA/BS required; degree in the life sciences or finance preferred
• 7+ years of experience, 2+ years of IR/Corporate Communications experience at a public biotech/pharma/life science company
• High attention to detail and strong interpersonal skills
• Strong planning, organizational, time, and project management skills to prioritize and complete multiple assignments and coordinate workflow
• Ability to appropriately handle confidential and sensitive information
• Advanced proficiency in MS Word, Excel, PowerPoint, and Outlook
• Ability to anticipate needs, be proactive, and exercise independent decision-making
• Ability to perform in a high-pressure environment and meet tight deadlines
• Superb written and verbal communication skills, as well as the ability to draft engaging and impactful messages 

• Complete clinical trial tasks and efficiently for assigned studies
• Assist with oversight of clinical study by tracking CRO and third-party vendors' activities
• Manage vendor(s) with supervision
• Coordinate investigator site contract and budget review
• Collaborate with study team to develop clinical trial documents, including informed consent forms, monitoring plans, protocols and amendments, trial logs, site tools, and other documents, as required
• Assist with budget oversight by tracking site payments and vendor invoices in collaboration with finance and study team
• Support clinical trial managers with study execution, according to good clinical practices (GCP) and standard operating procedures (SOPs). May coordinate activities with Clinical Research Organization (CRO), study vendors, and clinical sites
• Provide general logistical and administrative support for clinical trials, such as creating agendas and taking minutes at meetings, preparing for investigator meetings, and assisting with purchasing and work orders

• You take pride in being highly organized and have strong attention to detail
• You thrive in an environment where we work independently and on teams
• Your academic background includes a Bachelor’s Degree, preferably in a health or science field
• You have at least 4+ years of experience in clinical operations and study management within a life sciences company or at a CRO. Study Coordinator experience will be considered.
• You have experience with the study start-up process, global Phase I and II clinical trials - particularly Neuroscience, Oncology, orphan diseases and/or Immunology trials, and various clinical trial management systems (desirable)
• Basic knowledge of ICH/GCP and FDA regulations
• Occasional travel may be needed
• You have a point of view but are low ego

• Supporting the life cycle of our lab assets by maintaining instrument calibrations, servicing laboratory equipment, and updating equipment and asset databases. Coordinate lab equipment service schedule with IT and facilities.
• Collaborating with the internal team and our partners to maintain systems for tracking discovery samples, cell banks, and purchased reagents.
• Collaborating with the EH&S committee to establish and enforce environmental health and safety policies. Be a champion of Alector’s lab work policy and work towards becoming a point of contact for lab safety-related inquiries.
• Required travel, 50%, between Alector sites (South San Francisco and Newark).

• You have a Bachelor's degree in biology, chemistry or related field with 1-2 years of laboratory management experience in a biotechnology or academic laboratory setting
• You have hands-on experience working in a cell biology or analytical lab setting and are comfortable trouble shooting problems
• You have excellent organizational skills, sufficient to prioritize in a very fast-paced environment with changing priorities.
• You have strong communication skills.

• Mass spectrometry analysis of early and late-stage, research biomolecules in support of internal discovery efforts and phase appropriate IND/BLA filings
• Perform analytical method developments for various leading drug candidates
• Carry out formulation stability studies for new molecules from research to critical reagents

• A BS in scientific discipline e.g. chemistry, biochemistry, with 8+ years of related experience or an MS in scientific discipline e.g. chemistry, biochemistry, with 4-8 years of related experience
• 3-5 years of hand on experience in mass spectrometry.
• Strong hands-on experience using Mass Spectroscopy (specifically Orbitrap) to characterize monoclonal antibodies, bi-specific molecules, and new modalities.
• Hands-on experience in HPLC chromatography development work including RP, HIC, IEX, SEC.
• Demonstrated ability to design, execute and analyze experiments independently.
• A team player who is willing to work together and share knowledge and accomplishments.
• Managerial / mentorship experience is a plus.
• Strong and effective interpersonal skills with managers, peers, and cross-functional groups.
• Thrive and foster a culture of open communication and trust
• Strong organizational skills and strong attention to detail
• Ability to prioritize work to support drug development, and meet deadlines and timeframes.
• Effective work ethic and dedication to completing challenging projects.
• Strong problem-solving capabilities.
• Authored various technical documents, including Comparability Studies, GLP Studies, and Qualification Studies.
• Prepared and presented scientific results at meetings

• Support Study Lead in clinical trial planning through interaction with Key Opinion Leaders and Scientific Advisors
• All study activities at a program level, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports
• Vendor management including CROs, central labs, imaging, COAs
• Phase 2 study start-up and planning for phase 2 across indications
• Lead creation of monitoring plans, coordinating study reports, sections for Investigator's Brochures, and Regulatory documents (e.g., IND, NDA, or BLA)
• Plan resources and tasks to meet program objectives for timely initiation and completion of clinical studies
• Develop and review SOPs and guidelines for compliance with global regulatory requirements, including establishing appropriate processes and procedures to conduct global clinical trials
• Establish systems for tracking various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.
• Potential to elevate to the next level 

• Experience leading global Phase I-III clinical trials, particularly with a focus on Neuroscience, Oncology, orphan diseases, and/or Immunology
• Excellent project management skills and In-depth knowledge of ICH GCP guidelines
• An academic background that includes a Bachelor’s with 4+ years experience in clinical study management within a Pharmaceutical, Biotechnology company, or at a CRO
• Actively participated in leading clinical trial planning and execution from Phases 1-3. Oncology/Neuroscience experience is preferred
• Experience in leading and managing, trials including CROs, consultants, and vendors specific to the therapeutic areas (Neuroscience, Oncology)
• Take pride in being a team player, savvy, self-motivated, and efficient
• Proven track record of being a self-starter and troubleshooting independently
• Thrive in an environment where work is done independently and on teams

• Lead Phase 2 Alzheimer's study and primary point of contact for operational day-to-day activities and managing clinical trial execution
• Responsible for study activities, including investigator recruitment and site selection, study start-up, enrollment, data collection, drug projections, and reports
• Manage CRO, central lab, system vendors, and ancillary vendors to ensure on target, in budget deliverables with appropriate oversight
• Lead cross-functional Study Team, Stakeholder management with business partners, Key Opinion Leaders and Scientific Advisors, and external partners
• Manage creation of study plans and documents, coordinating study reports, and sections for Investigator’s Brochure and Regulatory documents (e.g., IND, NDA, BLA)
• Establish systems for tracking various activities during clinical trials (e.g., tracking metrics, monitoring reports, data review and query resolution, etc.)
• Plan resources and tasks to meet study and program objectives for timely initiation and completion of clinical studies
• Provide strategic input and leadership in study panning, set-up, and execution
• Contribute SOPs and guidelines in compliance with global regulatory guidelines and requirements.

• Have experience leading larger global Phase II-III clinical trials from planning to closeout, particularly with a focus in Neurology (ie Alzheimer’s, ALS, and other neurodegenerative diseases)
• Possess excellent project management skills with ability to prioritize, and collaborate with internal and external personnel
• Have an academic background which includes a Bachelor’s with 7+ years experience in clinical study management within a Pharmaceutical, Biotechnology company or at a CRO
• Are experienced managing CROs, consultants, and vendors in a complex team environment
• In-depth knowledge of FDA, EMEA, and ROW ICH and GCP guidelines
• Take pride in being a great teammate, savvy, self-motivated, and efficient
• Demonstrated track record of being a self-starter and troubleshooting independently
• Thrive in an environment where work is done both independently and on teams
• Managed direct reports and a champion for mentoring their team

• Oversee and manage the Safety Operations Team, Safety Surveillance and Safety Monitoring activities
• Insure proper support/resourcing for programs and team
• Continually improve the systems and processes

• Perform Sponsor Medical Review for all serious adverse events and adverse events of special interest in the Drug Safety Database

• Safety Lead for all Alector assets and develop the safety strategy to assess/mitigate the clinical risk identified and potential effects in humans
• Safety Lead providing as needed support, attendance of project and clinical team meetings on an as-needed basis
• Lead DMC/DSMB activities focused on Safety and partner with the Clinical Lead to manage these meetings for all the clinical programs.
• Influential member of the Alector Safety Management Team and Safety Committee

• Safety Lead for all Clinical Study Reports, Study Protocols, Investigator Brochures Perform review of risk rider language and informed consent forms (ICFs)
• Develop the Safety summarizations
• Review documents

• Perform review of Briefing documents as needed (Safety/Risk Information)
• Medical evaluation of Vendor Signal Detection Activities
• Review risk evaluation in Aggregate Safety Reports
• Approve Literature Search Strategy to ensure identification of new potential risk associated with Alector’s products
• Author Integrated Summary of Immunogenicity
• Review Integrated Summary of Safety
• Review CDP as applicable for risk mitigation planning

• Review of coding in EDC (i.e. medical hx, concomitant medications, AE terms) - upon joint agreement with Safety and Clinical team
• WHO Dictionary and MedDRA coding experience

• Point of contact for Safety risks identified by Medical Monitor
• Point of contact for Safety concerns/risks identified during Safety Surveillance Process / Aggregate Safety Reviews
• iDMC attendee & lead for all safety inquiries/discussions, including preparation for the meetings
• Lead/manage safety advisory boards, as necessary
• Safety correspondence with Health Authorities
• Informed of outcome of data review meetings

• MD degree with minimum of 10+ years of pharmacovigilance experience required; with previous signal detection/ safety surveillance and international experience.
• Experience in building a Pharmacovigilance department is desired.
• Board Certification with patient care experience is preferred.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies
• Experience in the preparation and authoring of aggregate safety reports, RMPs, and RSI
• Experience with antibody-based therapeutics strongly preferred, experience in neurology and/or oncology is additive.
• Previous work experience with a pharmaceutical company required
• Ability to apply principles, concepts and industry best practices governing pharmacovigilance and risk management in assigned projects.
• Strong verbal and written communication skills, as well as highly effective presentation and team-interaction skills are necessary.
• Proficiency in Microsoft Office; Argus or Veeva Vault Safety experience is a plus
• Efficient in time management and multi-tasking
• Strong organizational skills, including the ability to prioritize independently with minimal supervision
• An equivalent combination of education and experience may be considered.
• Embody and champion Alector’s values: Act with Integrity. Collaborate. Care.
• Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.