Senior Director, Clinical Pharmacology & Pharmacometrics

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.

• 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.

• 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.

• Prior exposure to BLA/MAA submission is strongly preferred.

• 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.

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.