Senior Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology

Primary Responsibilities

Lead and shape quantitative pharmacology strategy across oncology programs to inform key development decisions (e.g., dose selection, trial design, go/no-go decisions).

Develop and implement integrated MIDD strategies to support decision-making across development stages.

Ensure alignment of modeling strategies with regulatory expectations and business priorities.

Maintain a comprehensive understanding of global regulatory expectations for small molecules, biologics including new modalities such as ADCs and TCEs.

Lead, mentor, and develop a team of QP2 scientists, including performance management, hiring, retention, and talent development.

Contribute to broader QP2 and Oncology leadership initiatives, including talent strategies and organizational priorities.

Identify and support resource planning and allocation in partnership with senior leadership.

Serve as QP2 lead on assigned programs and represent QP2 in cross-functional teams and governance forums.

Collaborate with Translational, Clinical, and Biostatistics teams to integrate quantitative insights into development strategies.

Partner with preclinical teams to ensure appropriate translation of nonclinical findings into clinical development plans.

Contribute to due diligence for business development and licensing opportunities.

Regulatory & External Engagement

Develop and contribute to regulatory strategies, including authoring and reviewing key documents (e.g., INDs, CSRs, CTD modules, NDA/BLA submissions).

Ensure delivery of high-quality clinical pharmacology and pharmacometric analyses and reports.

Represent the company in interactions with regulatory agencies, scientific conferences, and external collaborations.

Required Education and Experience

Ph.D. in pharmacokinetics/pharmacodynamics, pharmacometrics, mathematics, statistics/biostatistics, chemical/biomedical engineering, or related discipline with ≥10 years of relevant pharmaceutical industry experience.

OR Master’s, PharmD, or equivalent degree with ≥15 years of relevant pharmaceutical industry experience, with a demonstrated record of increasing responsibility, independence, and leadership in similar roles.

Demonstrated ability to lead an interdisciplinary team or taskforce, and/or to oversee the work of others.

Extensive experience in developing quantitative strategies for impacting pipeline decisions, and drug development expertise.

Record of ability to operate in an inclusive and high-performance work environment applying enterprise ways of working principles including fostering collaboration and driving results, while managing ambiguity.

Relevant regulatory and quantitative pharmacology experience.

Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.