Senior Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology

Role Overview

• 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
• Provide scientific and operational oversight to team members, ensuring high-quality and timely deliverables
• 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
• 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

Requirements

• 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
• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, mathematics, computational biology, or a related field
• Oncology therapeutic area or disease knowledge
• 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
• Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)
• 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

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days