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About the role
Key responsibilities & impact- Lead DMPK and PK/PD strategy across discovery and development programs, from candidate nomination through clinical development and regulatory submission
- Drive clinical pharmacology strategy including dose finding, exposure–response modeling, PK/PD analysis, and risk-benefit assessment for early- and late-stage programs
- Oversee PK/PD study design, analysis, and interpretation, collaborating with clinical operations, biostatistics, and regulatory colleagues
- Provide scientific and regulatory support for DMPK, Clinical Pharmacology, and Biopharmaceutics sections of regulatory submissions, including IND, NDA, and BLA filings
- Act as the subject-matter expert for clinical pharmacology and DMPK in interactions with FDA, EMA, and other global health authorities
- Partner with translational, discovery, and clinical teams to integrate nonclinical ADME data into clinical development plans and support compound progression from pipeline to early development
- Work closely with Discovery and DMPK groups to provide PK/ADME support for discovery projects, enabling informed compound selection and optimization
- Ensure alignment of DMPK and PK/PD activities with clinical development, drug manufacturing, and regulatory plans across the portfolio
- Provide strategic and technical leadership to the AQP function on scientific matters, combining full-time and consulting resources
- Plan and conduct stage-appropriate Clinical Pharmacology studies (Phase I/II/III) to support regulatory submissions
Requirements
What you’ll need- PhD, PharmD, or MD in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline with 15+ years of relevant experience in biotech or pharma
- Demonstrated expertise in PK/PD, modeling & simulation, dose finding, and exposure-response strategies across nonclinical and clinical development
- Strong knowledge of Health Authority regulations and guidelines (ICH, FDA, EMA) for the development of small molecule therapies, with expert knowledge of those relating to Clinical Pharmacology/PK/PD
- Proven success representing Clinical Pharmacology and DMPK in regulatory interactions with FDA and ideally other regulators (e.g., FDA Pre-IND and EMA Scientific Advice meetings), and supporting IND, NDA, or BLA filings
- Extensive familiarity with major CROs and the ability to manage collaborations with CROs, academia, and industry partners
- Leadership experience managing teams and cross-functional collaborations, with excellent communication skills and the ability to influence at all levels from scientists to executive leadership
- Ability to manage multiple therapeutic programs in parallel and prioritize according to the needs of the company while delivering on key milestones
- Familiarity with non-oral small molecule delivery (formulation) approaches is a bonus; strong appreciation for research with a focus on product development.
Benefits
Comp & perks- 90% Medical, Dental, Vision
- 401k Match
- Flexible PTO
- Adoption Assistance
ATS Keywords
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Hard Skills & Tools
PharmacokineticsClinical PharmacologyPK/PD analysisModeling & simulationDose findingExposure-response modelingRegulatory submissionsADME data integrationClinical study designBiopharmaceutics
Soft Skills
LeadershipCommunicationCollaborationInfluencingStrategic planningTechnical leadershipProject managementPrioritizationTeam managementInterpersonal skills
Certifications
PhDPharmDMD