Associate Director - Director, Pharmacometrics

Position Overview

We are seeking an Associate Director – Director, Pharmacometrics with extensive hands-on experience in pharmacokinetic and pharmacometric analysis. This role will focus on conducting, reviewing, and delivering high-quality PK and PK/PD analyses including dataset creation, NCA, population PK (PopPK), and exposure–response (ER) modeling, to support clinical development and regulatory submissions. The ideal candidate will have 15+ years of practical experience performing analyses and will be proficient with industry-standard software and regulatory expectations.

This role will ideally be based in our Boston office and will follow a hybrid schedule, with three in-office days each week.

Responsibilities

• Develop, QC, and manage PK analysis datasets consistent with CDISC and regulatory standards.
• Perform non-compartmental analysis (NCA) of PK data using Phoenix WinNonlin or equivalent tools.
• Conduct population PK and ER modeling using NONMEM, R, or other appropriate platforms.
• Prepare summary tables, figures, and reports for study reports, investigator brochures, and regulatory submissions.
• Contribute to clinical pharmacology sections of regulatory documents (IND, NDA/BLA, MAA).
• Draft and maintain PK-related SOPs to ensure consistency and compliance across projects.
• Support software validation activities for PK and modeling platforms (e.g., NONMEM, Phoenix WinNonlin, R).
• Collaborate closely with Clinical Pharmacology, Biostatistics, and Regulatory teams to provide timely, high-quality deliverables.
• Act as a subject matter expert for internal teams and external partners on PK/PD and pharmacometric analyses.

Qualifications

• BS or MS in Pharmaceutical Sciences, Pharmacology, Biostatistics, or related field with 15+ years of hands-on pharmacometric/PK analysis experience in biotech or pharmaceutical industry.
• Proven expertise in PK dataset creation, PK NCA, PopPK, and ER modeling.
• Proficiency with NONMEM, R, and Phoenix WinNonlin; experience with additional tools (e.g., Monolix) is a plus.
• Strong knowledge of regulatory requirements and demonstrated experience contributing to regulatory submissions.
• Experience drafting and maintaining SOPs and conducting software validation under compliance standards.
• Excellent attention to detail, organizational skills, and ability to manage multiple projects with tight timelines.
• Strong written and verbal communication skills to document and present analytical results effectively.

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.