Director / Senior Director, DMPK
Formation Bio · Boston, MA · New York, New York, United States · hybrid
About Formation Bio
Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others.
You can read more at the following links:
- Our Vision for AI in Pharma
- Our Current Drug Portfolio
- Our Technology & Platform
At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.
About the Position
Formation Bio is seeking an experienced Director of Drug Metabolism and Pharmacokinetics (DMPK) to provide scientific and strategic leadership across our growing portfolio of development-stage therapeutics.
This role will have two important areas of responsibility. First, the Director will serve as a DMPK expert in the evaluation and diligence of potential in-licensing and acquisition opportunities, rapidly assessing the quality of available data, identifying key risks and uncertainties, and developing a clear view of an asset’s pharmacokinetic, translational, and clinical potential. Second, the Director will provide DMPK leadership for programs in our advanced preclinical and clinical pipeline, integrating nonclinical and clinical data to support development strategy, dose selection, clinical pharmacology, and regulatory decision-making.
The ideal candidate combines deep technical expertise in DMPK with excellent drug-development judgment. They are equally comfortable digging into source data during a fast-moving diligence process, developing a quantitative understanding of an asset’s PK and exposure-response relationships, and representing DMPK on a multidisciplinary development team.
This is a highly cross-functional role with the opportunity to influence both which medicines Formation Bio brings into its portfolio and how we develop them.
Responsibilities
- Serve as the DMPK subject-matter expert for scientific diligence of potential in-licensing, acquisition, and partnership opportunities across a range of therapeutic areas and stages of development.
- Rapidly evaluate nonclinical and clinical PK (in collaboration with Clinical Pharmacology), ADME, metabolism, transporter, bioavailability, PK/PD, and exposure-response datasets to assess an asset’s strengths, liabilities, and development potential.
- Critically assess the quality and completeness of available data, identify important gaps or inconsistencies, and distinguish issues that represent material development risks from those that can be readily addressed.
- Evaluate human PK characteristics, dose and exposure projections, therapeutic margins, DDI potential, organ impairment considerations, formulation and absorption issues, and other factors that may affect an asset’s clinical profile.
- Integrate DMPK findings with pharmacology, toxicology, clinical, CMC, and regulatory information to develop a holistic assessment of an asset.
- Develop clear, decision-oriented recommendations for cross-functional diligence teams and senior leadership, including articulation of key risks, uncertainties, potential mitigations, and value-creating opportunities.
- Define priority experiments, analyses, or data requests needed to resolve critical questions during diligence and transition promising assets into the Formation Bio portfolio.
- Preclinical & Clinical Development
- Provide DMPK leadership for advanced preclinical and clinical-stage programs, serving as the DMPK representative on cross-functional development teams.
- Develop fit-for-purpose DMPK strategies from late preclinical development through IND/CTA, early clinical development, and subsequent stages of development.
- Integrate in vitro ADME, animal PK, toxicokinetics, clinical PK, pharmacology, biomarker, and safety data to develop a quantitative understanding of exposure and response.
- Lead human PK prediction and nonclinical-to-clinical PK/PD translation to inform FiH dose selection, and partner with Clinical Pharmacology and Pharmacometrics to support clinical dose escalation and dose optimization
- Partner with Clinical Pharmacology to Identify and investigate unexpected or suboptimal clinical PK and develop hypotheses, analyses, and studies to inform program decisions.
- Partner with Clinical Pharmacology to provide strategic oversight for metabolism, transporter and DDI assessments, metabolite characterization, MIST strategy, mass-balance studies, organ impairment assessments, food-effect studies, and other relevant clinical pharmacology activities.
- Partner closely with Clinical Pharmacology, Pharmacometrics, Clinical Development, Toxicology, CMC, and other functions to optimize development plans.
- Contribute to regulatory strategy and author or critically review relevant sections of INDs, CTAs, briefing documents, and other regulatory submissions.
- Provide scientific oversight of CROs, consultants, and other external partners conducting DMPK and related studies.
- Scientific & Programmatic Leadership
- Bring an informed perspective to DMPK questions, ensuring that the depth and timing of work are appropriate to the maturity, risk, and value of each program.
- Develop integrated views of DMPK and translational risk that enable rapid, high-quality portfolio decisions.
- Establish and evolve fit-for-purpose DMPK capabilities, external partnerships, analytical approaches, and best practices as Formation Bio’s portfolio grows.
- Communicate complex scientific findings clearly and concisely to multidisciplinary teams and senior leadership.
About You
- PhD in pharmaceutical sciences, pharmacokinetics, pharmacology, chemistry, biochemistry, or a related discipline, with typically 8+ years of relevant biotechnology or pharmaceutical industry experience, or an equivalent combination of education and experience.
- Deep expertise in DMPK with substantial experience supporting development-stage small-molecule programs.
- Demonstrated experience integrating nonclinical and clinical PK data to guide drug-development decisions.
- Strong understanding of ADME, clearance mechanisms, drug metabolism, transporters, absorption and bioavailability, protein binding, tissue distribution, and drug-drug interactions.
- Experience with human PK prediction, PK/PD and exposure-response analysis, and clinical translation.
- Experience supporting IND-enabling development and clinical-stage programs; direct experience supporting first-in-human and subsequent clinical studies strongly preferred.
- Strong working knowledge of regulatory expectations for DMPK and clinical pharmacology during drug development.
- Experience evaluating complex datasets and making recommendations when information is incomplete, inconsistent, or evolving.
- Demonstrated ability to work effectively with external CROs, consultants, and partners.
- Excellent written and verbal communication skills, including the ability to synthesize complex technical information into clear conclusions for non-specialist and senior audiences.
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