Director / Senior Director, DMPK

Formation Bio•Boston, MA

3d•$245,500 - $388,500•Hybrid

About The Position

Formation Bio is seeking an experienced Director of Drug Metabolism and Pharmacokinetics (DMPK) to provide scientific and strategic leadership across its growing portfolio of development-stage therapeutics. The role combines expert DMPK diligence of potential in-licensing, acquisition, and partnership opportunities with DMPK leadership for advanced preclinical and clinical programs. The Director will assess data quality, risks, uncertainties, and an asset’s pharmacokinetic, translational, and clinical potential, then integrate nonclinical and clinical information to guide development strategy, dose selection, clinical pharmacology, and regulatory decisions. The role works closely with multidisciplinary teams and senior leadership, applying deep DMPK expertise and drug-development judgment to fast-moving diligence and program decisions. The successful candidate will evaluate complex datasets, develop quantitative views of PK and exposure-response relationships, recommend follow-up experiments and analyses, and help establish fit-for-purpose DMPK capabilities as the portfolio grows. Formation Bio is a technology- and AI-driven pharmaceutical company focused on making drug development and clinical trials more efficient. The company partners with, acquires, or in-licenses drug programs to advance them past clinical proof of concept and beyond. Hiring is focused primarily on the New York City and Boston metro areas, with a hybrid model requiring three days per week in the office. Applicants from the Research Triangle and San Francisco Bay Area may also be considered; candidates must live in these locations or be willing to relocate.

Requirements

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 DMPK expertise and 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.
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.

Nice To Haves

Direct experience supporting first-in-human and subsequent clinical studies.

Responsibilities

Serve as the DMPK subject-matter expert in scientific diligence for potential in-licensing, acquisition, and partnership opportunities across therapeutic areas and development stages.
Evaluate nonclinical and clinical PK, ADME, metabolism, transporter, bioavailability, PK/PD, and exposure-response datasets, collaborating with Clinical Pharmacology as appropriate.
Assess data quality and completeness, identify gaps or inconsistencies, and distinguish material development risks from issues that can be addressed.
Evaluate human PK characteristics, dose and exposure projections, therapeutic margins, DDI potential, organ impairment considerations, formulation and absorption issues, and other factors affecting clinical profiles.
Integrate DMPK findings with pharmacology, toxicology, clinical, CMC, and regulatory information to develop holistic asset assessments.
Develop decision-oriented recommendations for diligence teams and senior leadership, including risks, uncertainties, mitigations, and value-creating opportunities.
Define priority experiments, analyses, and data requests to resolve diligence questions and support the transition of promising assets into the portfolio.
Provide DMPK leadership for advanced preclinical and clinical-stage programs 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.
Integrate in vitro ADME, animal PK, toxicokinetics, clinical PK, pharmacology, biomarker, and safety data to characterize exposure and response quantitatively.
Lead human PK prediction and nonclinical-to-clinical PK/PD translation to inform first-in-human dose selection, partnering with Clinical Pharmacology and Pharmacometrics on dose escalation and optimization.
Partner with Clinical Pharmacology to investigate unexpected or suboptimal clinical PK and develop hypotheses, analyses, and studies to inform program decisions.
Partner with Clinical Pharmacology to oversee metabolism, transporter and DDI assessments, metabolite characterization, MIST strategy, mass-balance studies, organ impairment assessments, food-effect studies, and other relevant activities.
Work 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.
Ensure the depth and timing of DMPK work are appropriate to each program’s maturity, risk, and value.
Develop integrated assessments of DMPK and translational risk to support rapid, high-quality portfolio decisions.
Establish and evolve fit-for-purpose DMPK capabilities, external partnerships, analytical approaches, and best practices as the portfolio grows.
Communicate complex scientific findings clearly and concisely to multidisciplinary teams and senior leadership.