Senior Director, Clinical Pharmacology & Pharmacometrics

Bicara Therapeutics • Boston, MA

9d • Hybrid

About The Position

Bicara Therapeutics is seeking an experienced and strategic Senior Director of Clinical Pharmacology & Pharmacometrics to lead clinical pharmacology, pharmacometrics, and translational PK/PD strategy across all stages of drug development. Reporting to the VP, Clinical Pharmacology, this individual will play a critical role in dose selection, exposure-response evaluation, model-informed drug development, and regulatory submissions, including BLA/MAA.
The role requires deep expertise in biologics development, advanced modeling and simulation methodologies, and a proven track record of regulatory impact in late-stage programs.
This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Requirements

• PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, or related discipline
• 10+ years’ of direct biotech industry and/or CRO experience in clinical pharmacology and pharmacometrics
• Strong background in biologics development (e.g., monoclonal antibodies, fusion proteins, immuno-oncology agents)
• Expertise in population PK/PD and exposure–response modeling
• Proficiency with NONMEM, R, and related modeling platforms

Nice To Haves

• Prior exposure to BLA/MAA submission strongly preferred

Responsibilities

• Lead clinical pharmacology strategy across all stages of drug development including scientific and operational oversight
• Drive dose selection and exposure–response strategy using model-informed drug development approaches across all stages of development
• Lead population PK (PopPK), PK/PD, exposure–response, and disease modeling analyses to inform clinical drug development using model-based approach
• Design and oversee model-informed drug development (MIDD) strategies using population and statistically based methodologies
• Author and review Clinical Pharmacology sections of INDs, CSR, IB, BLAs, and global submissions.
• Stay current with global regulatory expectations for biologics to contribute to cross-functional strategy.
• Partner closely with Clinical Development, Biostatistics, Regulatory Affairs, Translational Sciences, and Bioanalytical teams serving as an SME in cross-functional discussions
• Oversee CROs and external modeling vendors as needed

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree