Senior Director, Pharmacometrics

Modeling, Simulation, and Quantitative Strategy 

• Lead the development and execution of population PK, PK/PD, exposure-response, disease progression, and model-based meta-analysis strategies to support clinical development and registration. 

• Apply fit-for-purpose PBPK, QSP, translational modeling, or simulation approaches to inform first-in-human strategy, dose escalation, dose expansion, special populations, drug-drug interaction risk, and lifecycle development. 

• Oversee analysis plans, model development, simulations, quality control, and interpretation of pharmacometric outputs to ensure scientific rigor, reproducibility, and regulatory readiness. 

Program Oversight and Execution 

• Partner with Clinical Pharmacology, Clinical Development, Biostatistics, ADME, Translational Science, Bioanalytical, Regulatory, Clinical Operations, Data Management, and Medical Writing to integrate pharmacometrics deliverables into development plans and study timelines. 

• Provide input into clinical protocols, sparse and intensive PK/PD sampling strategies, statistical analysis plans, data standards, and integrated evidence generation plans. 

• Serve as the primary pharmacometrics representative on cross-functional program teams and governance forums, translating quantitative findings into clear development recommendations. 

Regulatory and Documentation Support 

• Author, review, and provide strategic oversight for pharmacometrics components of clinical pharmacology plans, modeling and simulation analysis plans, reports, investigator brochures, clinical study reports, and regulatory submissions. 

• Lead pharmacometrics contributions to INDs, NDAs, BLAs, briefing books, responses to health authority questions, and labeling discussions. 

• Ensure pharmacometrics activities are conducted in alignment with applicable FDA, EMA, ICH, and global regulatory expectations for model-informed drug development, population PK, and exposure-response analyses. 

Vendor and Partner Management 

• Identify, qualify, and manage external pharmacometrics vendors, consultants, and CRO partners to ensure high-quality, timely, and scientifically robust deliverables. 

• Maintain oversight of outsourced analyses, including scope definition, budget planning, timeline management, technical review, and quality control of modeling and simulation outputs. 

Leadership and Collaboration 

• Lead and mentor pharmacometricians and quantitative scientists, fostering an environment of scientific excellence, innovation, accountability, and collaboration. 

• Communicate complex modeling results and development implications clearly to senior leaders, cross-functional stakeholders, external collaborators, and regulatory audiences. 

• Collaborate closely with Clinical Pharmacology, Clinical Development, Regulatory, ADME, Bioanalytical, Translational Science and Biometrics functions to align quantitative strategies with broader development objectives. 

Qualifications

• Ph.D. in Pharmacometrics, Clinical Pharmacology, Pharmaceutical Sciences, Statistics, Bioengineering, Applied Mathematics, or related quantitative discipline with 12+ years of relevant experience in the biopharmaceutical industry; M.S. with 15+ years; or B.S. with 18+ years of relevant experience in clinical pharmacology, pharmacometrics, quantitative pharmacology, or related drug development functions, or equivalent experience. 

• Demonstrated track record leading pharmacometrics strategy and execution across multiple clinical-stage programs, including early development, late-stage development, and regulatory submission support. 

• Deep expertise in population PK, PK/PD, exposure-response, simulation, dose optimization, and model-informed drug development. 

• Experience supporting global regulatory filings and interactions, including IND, NDA, BLA, briefing book, labeling, and health authority response activities. 

• Hands-on experience with pharmacometrics and quantitative analysis tools such as NONMEM, Monolix, Phoenix, R, SAS, Python, MATLAB, Simcyp, GastroPlus, or related platforms. 

• Experience managing external pharmacometrics vendors, CROs, consultants, and cross-functional deliverables. 

• Oncology drug development experience required; experience with ADCs, biologics, targeted radiotherapies, or small molecules preferred. 

Knowledge and Skills

• In-depth knowledge of clinical pharmacology, pharmacometrics, population PK, exposure-response, PBPK, QSP, translational modeling, and quantitative decision-making across drug development. 

• Strong understanding of global regulatory expectations for model-informed drug development, dose justification, labeling support, and submission-quality pharmacometrics documentation. 

• Proven leadership and project management skills across multiple programs, vendors, timelines, and stakeholders. 

• Excellent communication skills — capable of clearly conveying complex quantitative analyses, assumptions, limitations, and recommendations to diverse technical and non-technical audiences. 

• Demonstrated success influencing cross-functional teams and driving data-informed decisions in a matrixed biotech or pharmaceutical environment. 

• Exceptional organizational, analytical, and problem-solving skills with a commitment to scientific rigor, quality, and reproducibility.