Longevity Industry Jobs

As a member of the pharmacology team at Fulcrum Therapeutics, this role will be responsible for the design and execution of mechanistic in vivo and ex-vivo pharmacology research projects in research areas such as genetically defined hematological, musculoskeletal, and other rare disorders. The candidate will be part of a multi-disciplinary team to conduct experiments aimed at building relationships between in vitro cellular assays and in vivo/ ex-vivo PK/PD, target engagement, and efficacy of potential drug candidates to drive drug discovery. We seek an innovative scientist who is looking to be part of a dynamic team, open to new challenges and excited to have a direct impact on the discovery and development of novel therapies for patients living with rare diseases.

Responsibilities

• Responsible for independently conducting in vivo studies with rodents in accordance with IACUC requirements.
• Contribute to study designs, planning and performing in vivo studies related to PK/PD and efficacy studies from early exploratory to IND stage.
• Provide analysis and interpretation of data with clear communication in cross-functional team meetings.
• Perform routine rodent handling and dosing independently by various routes (e.g., oral gavage, IP, IV, SC, IM)
• Perform blood draws, necropsies, and process ex vivo samples.
• Conduct assays for ex vivo target engagement and biomarker analysis from tissue and blood samples to understand the mechanism of action of various therapeutic agents.
• Ability to conduct in vitro assays, gene expression analysis, protein analysis and general molecular biology techniques is a plus.
• Demonstrate independent thought/creativity in science with excellent collaboration and communication across functional disciplines, multitasking skills and able to present work formally to scientific research committees.
• Maintain accurate, timely and complete electronic laboratory notebook entries.

Qualifications

• BS or MS with relevant experience in areas related to Cell Biology, Molecular Biology and/or Pharmacology in an academic or industry setting.
• Proven track record of performing in vivo experiments in rodents, including handling, dosing and necropsy.
• Experience managing CROs desired.
• Hands-on experience with a range of in vitro/ ex vivo techniques (such as RNA/DNA extraction, qPCR, ELISA, protein analysis via Western blot, WES, and/or MSD) is desirable.
• Experience running flow, ICC, FISH, and/or IHC imaging assays is a plus.
• Demonstrated ability to execute experiments, analyze data and report conclusions.
• Passionate about contributing to the team in a diverse and inclusive environment every day, in- and outside the lab.
• Ability to thrive in a highly collaborative, fast-paces, team-oriented environment with diverse disciplines.
• Outstanding interpersonal and communication (written and verbal) skills; demonstrates calm, professional, diplomatic, and positive behaviors.

Reporting to our Chief Scientific Officer, the Director of Muscle Biology will be a highly driven scientific leader who is dedicated to performing great science that transforms patients’ lives. They are a dedicated drug hunter, and will lead the development of our Muscle Franchise strategy and portfolio. The successful candidate will partner with colleagues in FulcrumSeek™, medicinal chemistry, DMPK and in vivo pharmacology to translate this team’s scientific discoveries into new medicines. This is a forward-facing leadership role, requiring cross-functional collaboration, establishing liaisons with KOLs, and routine interface with members of the Executive Team. As a highly experienced scientist, the Director of Muscle Biology is expected to play a large role in the mentorship and development of their team, teaching what “good” looks like in drug discovery. They should maintain a strategically focused lab and should be able to lead by example.

Responsibilities

• Perform scientific research with the goal of discovering transformative first-in-class medicines
• Lead, mentor, and coach your team of direct reports in the art and science of drug discovery
• Work cross-functionally with colleagues in FulcrumSeek™, our patient-focused product engine designed to systematically identify high-value, de-risked targets, collaborating in the design of work streams focused on elucidating new target biology for rare muscle and neuromuscular diseases
• Leverage disease biology and drug discovery expertise to validate targets and build pharmacological relationships across a diversity of fit-for-purpose pre-clinical models, building robust in vitro and in vivo pharmacology data packages
• In-source capability and out-source capacity by establishing strategic and highly productive partnerships with leading CROs; teach your team how to lead in the absence of a line reporting relationship through your effective management of these relationships
• Collaborate with stakeholders in clinical development and commercial to set long-term strategy and establish new opportunities for the Muscle Therapeutic Area
• Implement a translational biology strategy for neuromuscular diseases including but not limited to PK/PD and therapeutic biomarkers
• Work with Business Development team to generate content for partnership discussions and perform due diligence for on-strategy in-licensing opportunities
• Interface with internal and external KOL networks for input on target hypotheses, models, and technologies
• Participate as an active thought partner in the overall company strategy; periodically present to the Executive Team and the Board

Qualifications

• Ph.D. in biology, physiology, molecular and/or cellular biology with 10+ years of industry experience
• Proven track record of performing research with the goal of discovering new medicines; has served as a project team leader or co-leader for a drug discovery program that successfully identified a development candidate
• Experience and effectiveness working in a multidisciplinary team environment with common goals, and operating in a matrixed environment is essential
• Experienced team leader who effectively manages external collaborations and service providers with the ability to bring a pragmatic business-minded approach to balancing internal and external capabilities
• Experience managing PhD-level reports
• Ability to provide novel, innovative solutions to challenging problems and identify key gaps; responds to stress with humor and professionalism
• Desire to learn and tackle new challenges and initiatives
• Possesses a high degree of scientific discretion, intuition and integrity
• High attention to detail, strong written and verbal communication skills, and ability to effectively collaborate across groups at all stages of projects
• Ability to communicate effectively to non-technical audiences

The Disease Modeling team is seeking a Senior Research Associate (Sr. RA) to play a pivotal role in the advancement of high priority drug discovery projects through the design, development, and execution of decision-making in vitro cell-based assays. As a key contributor to our pioneering high-throughput discovery engine, FulcrumSeekTM, you will work closely with others on our team to drive the cell biology that is key to our disease-centric approach. The primary objectives of the Sr. RA in this role will be to generate and characterize patient-derived, disease relevant cellular models that will serve as a foundation for our drug discovery efforts. We seek an innovative individual who is looking to be part of a dynamic team, open to new challenges, and excited to make a direct impact on progressing novel therapies to patients.

Responsibilities

• Be a key contributor to cell biology efforts for multiple disease-centric project teams
• Expand, cryopreserve, and characterize human iPSCs
• Support the processes of scaling differentiation of iPSCs into multiple disease-relevant cell types, with an immediate emphasis on cardiomyocytes
• Work with others on the team to establish next-generation disease-relevant cell culture models, including iPSC-derived cell models and co-culture systems
• Develop and optimize QC methods for available and newly developed cellular models
• Contribute to the development and implementation of plate-based cellular assays to characterize disease-relevant phenotypes (RT-qPCR, imaging, and functional assays)
• Keep detailed notes of protocols and develop SOPs for cross-platform integration
• Present and discuss results with the Fulcrum research team and the external research community; work collaboratively with a cross-functional team of talented scientists

Desired Qualifications

• Bachelor’s with 5+ years of experience or Master’s with 3+ years of experience in an academic or industry setting
• Experience with iPSC culture including differentiation, expansion, and characterization of downstream derivatives. Previous experience with cardiomyocytes is a plus
• Understanding of high content imaging technologies and experience with assay development for imaging-based characterization of cellular models
• Familiarity with molecular tools and techniques (RT-qPCR, transfections, RNAi/CRISPR, AlphaLisa, MSD etc.)
• Experience in functional assays to identify disease-related phenotypes using in vitro models is a plus (electrophysiology, metabolism, genomics, etc)
• Demonstrated ability to thrive in a collaborative team environment
• Strong hands-on experimental background with a rigorous, analytical approach to problem solving

Reporting to and in partnership with the Senior Vice President of Regulatory Affairs and Quality Assurance, this position will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key stakeholders. This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and life cycle of the product.

Responsibilities

Primary responsibilities include strategic planning, preparation of critical submission documentation, communication with global health authorities, participation in meetings with global health authorities and mentorship of a growing regulatory team

• Provide expertise in translating regulatory requirements into practical strategic regulatory plans
• Develop and implement strategies to facilitate the progress of products into clinical trials and through to registration
• Drive cross-functional partnerships, foster collaboration, and build consensus across various disciplines, including (but not limited to) clinical development, research, manufacturing, business development, and external CRO’s
• Serve as global regulatory liaison with health authorities
• Review technical reports and summary documents for adherence to regulatory guidelines, strategies, and commitments
• Maintain awareness of global regulatory environment and regulatory precedents to assess potential relevance for company product development programs

Qualifications

• At least 10 years of drug development experience with 8+ years of varied experience in Regulatory Affairs
• Strong strategic skills and the willingness to perform operational tasks as needed
• Rare disease experience preferred
• Experience having managed significant accelerations and complex clinical programs
• Excellent communication, negotiation and influencing skills
• Ability to prioritize workload
• Embraces a culture of scientific rigor, passion, and urgency
• A professional, positive, and energetic individual, the candidate will have a participative management style, sound organizational savvy and the ability to operate and lead others in a flexible, evolving environment

Reporting to our Chief Scientific Officer, The Director and Head of Medicinal Chemistry will be a highly driven scientific leader who is dedicated to transforming novel target biology into innovative first-in-class medicines. They are a dedicated drug hunter and will be responsible for the design, synthesis, and optimization of small-molecule drug candidates, from hit identification through Development Candidate selection. In this strategic role, the successful candidate will engage with colleagues in FulcrumSeek™ and in exploratory biology, and will drive insights in novel target biology to transformative new medicines. Specifically, this individual will optimize small molecule “hits” by identifying structure-activity relationships and thereby design novel chemical entities optimized for potency, selectivity, pharmacokinetics, in vivo efficacy, and overall pharmaceutical properties. You will collaborate with a dynamic multi-disciplinary team of biologists and pharmacologists, and you will also manage and lead a large team of synthetic chemists at our external CROs. As our Head of Medicinal Chemistry, you will have collaborative engagement with the external scientific community, routinely present to our Executive Team, and make direct contributions to Fulcrum’s external reputation.

Responsibilities

• ”Own” the medicinal chemistry function at Fulcrum, bringing in new capabilities as required, identifying key collaborators and CROs, and inspiring best-in-class approaches to small molecule drug discovery
• Further cultivate and lead our consortium of thought leaders and consultants in medicinal chemistry, structural biology and machine learning/AI to bring best-in-class innovation to our drug discovery workstreams
• Develop strategies and tactics for ‘drugging’ the novel target biology identified from our FulcrumSeek platform and our exploratory biology efforts
• Design new bioactive compounds by collaborating with your colleagues in the biological sciences to optimize potency, selectivity, DMPK, in vivo pharmacology, and pharmaceutical properties
• Refine our outsourcing strategy with our external CROs, and lead the efforts of a large team of synthetic chemists in the focused and effective optimization of our drug leads
• Identify novel composition-of-matter, and liaise with our patent attorneys to create intellectual property strategies that leverage our inventions

Qualifications

• Ph.D. in synthetic organic chemistry or equivalent with 10+ years of industry experience
• Proven track record in drug discovery; has served as a project team leader or co-leader or key innovator for a discovery program that successfully identified an IND candidate; routine inventor/co-inventor of composition-of-matter IP
• Excellent knowledge of medicinal chemistry; conversant in project biology and pharmacology, and with treatment modalities beyond small molecules
• Demonstrated excellence in organic synthesis; conversant with principles of structure-based drug design and in silico/AI/ML approaches to both structure- and ligand-based drug design
• Exceptional knowledge of ADME, physicochemical, biochemical and pharmacological principles as applied to drug discovery
• Proven leadership capability in cross-functional team settings, either as project team leader or co-lead
• Exceptional interpersonal, verbal and written communication skills, and able to present the rationale, key data, issues and accomplishments of our drug discovery efforts to internal and external collaborators