Senior Director, Clinical Pharmacology, Pharmacometrics
Bicara Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $276,000 - $346,000 per year
Job Level
About the role
- 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.
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.
- 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.
Benefits
- medical, dental, and vision coverage upon hire
- short term and long-term incentives including cash bonus and equity incentive opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical pharmacologypharmacometricspopulation PKPK/PD modelingexposure-response modelingmodel-informed drug developmentstatistical methodologiesbiologics developmentdose selectiondisease modeling
Soft Skills
leadershipstrategic oversightcross-functional collaborationcommunicationscientific oversightoperational oversightpartnershipreview and authoring
Certifications
PhD in Clinical PharmacologyPhD in PharmacometricsPhD in Pharmaceutical SciencesPhD in PharmacologyPhD in Biomedical Engineering