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About the Role

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 involves serving as a DMPK expert for evaluating new opportunities and providing DMPK leadership for programs in our pipeline, integrating data to support development strategy and decision-making.

Responsibilities

Serve as the DMPK subject-matter expert for scientific diligence of potential in-licensing, acquisition, and partnership opportunities.
Rapidly evaluate nonclinical and clinical PK, ADME, metabolism, transporter, bioavailability, PK/PD, and exposure-response datasets.
Critically assess data quality, identify gaps, and distinguish material development risks.
Evaluate human PK characteristics, dose and exposure projections, therapeutic margins, DDI potential, and organ impairment considerations.
Integrate DMPK findings with pharmacology, toxicology, clinical, CMC, and regulatory information for holistic assessment.
Develop decision-oriented recommendations for diligence teams and senior leadership.
Define priority experiments, analyses, or data requests to resolve critical questions during diligence.
Provide DMPK leadership for advanced preclinical and clinical-stage programs.
Develop fit-for-purpose DMPK strategies from late preclinical development through IND/CTA and early clinical development.
Integrate in vitro ADME, animal PK, toxicokinetics, clinical PK, pharmacology, biomarker, and safety data.
Lead human PK prediction and nonclinical-to-clinical PK/PD translation to inform FiH dose selection.
Partner with Clinical Pharmacology to identify and investigate suboptimal clinical PK.
Provide strategic oversight for metabolism, transporter and DDI assessments, metabolite characterization, MIST strategy, mass-balance studies, organ impairment assessments, and food-effect studies.
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.
Bring an informed perspective to DMPK questions, ensuring appropriate depth and timing of work.
Develop integrated views of DMPK and translational risk for rapid portfolio decisions.
Establish and evolve fit-for-purpose DMPK capabilities, external partnerships, analytical approaches, and best practices.
Communicate complex scientific findings clearly and concisely to multidisciplinary teams and senior leadership.

Requirements

PhD in pharmaceutical sciences, pharmacokinetics, pharmacology, chemistry, biochemistry, or a related discipline.
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.

Skills

DMPK
Scientific diligence
PK/PD
ADME
Drug metabolism
Transporters
Bioavailability
Exposure-response analysis
Clinical pharmacology
Regulatory submissions

Location

New York City metro area
Boston metro area
Research Triangle (NC)
San Francisco Bay Area

Work Type

Hybrid

Experience Level

Director
Senior Director

Education Level

Salary/Compensations

$245,500 - $388,500

Benefits

Equity
Comprehensive benefits
Generous perks

About the Company

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.
Formation Bio has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials.
The company partners, acquires, or in-licenses drugs 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.
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.

Equal Opportunity

Formation Bio is committed to building a diverse and inclusive team.
We are an equal opportunity employer and welcome candidates from all backgrounds.
All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.