Senior Director, Clinical Pharmacology, Pharmacometrics

Bicara Therapeutics

Senior Director leading clinical pharmacology and pharmacometrics strategy for drug development at Bicara Therapeutics. Focus on dose selection and regulatory submissions across biologics development.

Posted 4/12/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $276,000 - $346,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

medical, dental, and vision coverage upon hire
short term and long-term incentives including cash bonus and equity incentive opportunities

ATS Keywords

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Applicant Tracking System Keywords

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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