Senior Director, Clinical Pharmacology & Pharmacometrics

Position Overview 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. 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 Qualifications 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 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 Company Overview Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. 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. Compensation Range: $276K - $346K