Director/ Senior Director NCD – ADME/DMPK

Seeking an experienced ADME/DMPK leader to provide strategic direction and execution of drug metabolism, pharmacokinetics, and disposition activities across the portfolio. This role serves as the ADME/DMPK subject matter expert, supporting programs from candidate selection and IND-enabling studies through late-stage clinical development, registration, and regulatory interactions. The successful candidate will drive development strategy, assess risk, and deliver high-quality nonclinical packages in a fast-paced biotech environment.

Key Responsibilities

• Develop and execute ADME/DMPK strategies from candidate selection through Phase 3 development and registration.
• Serve as the ADME/DMPK representative on cross-functional teams, contributing to program strategy, risk assessment, and development decisions.
• Design, oversee, and interpret ADME/DMPK studies, including pharmacokinetics, metabolite identification, drug-drug interactions, transporter assessments, mass balance/disposition, translational PK, species selection, and bioanalytical support.
• Lead exposure-based assessments to inform toxicology studies, clinical dose selection, and registration planning.
• Evaluate nonclinical data packages, identify development risks, and recommend mitigation strategies aligned with regulatory expectations.
• Manage external CROs and bioanalytical laboratories, including study oversight, reporting, and budgets.
• Partner with Clinical Pharmacology, Clinical Development, Regulatory Affairs, and Translational Sciences to support development strategy and dose optimization.
• Author and review ADME/DMPK sections of regulatory submissions (INDs, IBs, NDAs, and global filings) and support health authority interactions.
• Communicate key findings to project teams, governance committees, partners, and due diligence stakeholders.
• Contribute to continuous improvement of nonclinical development capabilities and processes.

Qualifications

Required

• PhD or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Drug Metabolism, Pharmacology, or related discipline.
• 10+ years of industry experience in ADME/DMPK and nonclinical drug development.
• Expertise in ADME, pharmacokinetics, drug disposition, metabolite characterization, and translational science.
• Experience supporting IND-enabling and clinical-stage development programs.
• Proven track record managing outsourced ADME, DMPK, and bioanalytical studies.
• Strong knowledge of global ADME/DMPK regulatory requirements and experience contributing to regulatory submissions and agency interactions.
• Excellent scientific communication and presentation skills.

Preferred

• Experience supporting Phase 3 development and NDA/BLA submissions.
• Experience with small molecules and peptide therapeutics.
• Familiarity with PBPK modeling and translational PK approaches.
• Global regulatory experience, including EMA and PMDA interactions.
• Prior experience in a biotech or startup environment.