Role Summary
Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. The Executive Director, Clinical Science is a senior enterprise leader accountable for scientific rigor, executional excellence, and organizational performance across Clinical Development. The role leads the Clinical Science Center of Excellence (CoE) to ensure consistency, quality, and best practices across the portfolio. It combines strategic leadership with hands-on program leadership to drive decision-ready data and enable rapid, high-quality development decisions.
Responsibilities
- Serve as functional head of Clinical Science, accountable for performance, quality, and talent development across the portfolio.
- Establish and uphold scientific rigor and consistency across clinical programs.
- Lead, mentor, and develop Clinical Scientists and, when appropriate, therapeutic area agonistic junior Medical Directors.
- Define, implement, and continuously improve clinical science standards, best practices, and governance.
- Ensure high-quality data review, clear benefit–risk framing, and actionable recommendations to support development and regulatory decisions.
- Translate portfolio priorities into resourcing strategies, capability development, and measurable objectives.
- Build robust talent pipelines through hiring, development, and succession planning.
- Enable and support enterprise early development activities in close partnership with Pipeline Strategy, Asset Teams, and therapeutic area leads.
- Ensure early clinical trials are designed to effectively translate biology into decision-ready clinical evidence.
- Integrate Clinical Pharmacology, Biostatistics, Biomarkers, Translational Sciences, Regulatory, and other functions to deliver coherent dose and development strategies.
- Provide oversight and clinical input of Clinical Pharmacology, ensuring strong clinical context for PK/PD, exposure–response, dose justification, and model-informed development in collaboration with subject matter experts.
- Establish fit for purpose early development processes, standards, and governance to enable efficient learning, rapid risk reduction, and high-quality decision making.
- Provide scientific oversight of early phase studies, ensuring alignment with target product profiles and downstream development needs.
- Partner with Research and Pipeline Strategy to ensure seamless transition of assets into early clinical development.
- Ensure early programs generate data that clearly support go/no-go and phase transition decisions.
- Support the establishment of new therapeutic areas by providing appropriate early clinical development leadership and infrastructure.
- Strengthen the Clinical Development operating model to improve speed, rigor, accountability, and cross-functional alignment.
- Improve decision quality, clarity of tradeoffs, and follow-through across early development programs.
- Mentor emerging leaders to build enterprise leadership capability.
- Promote disciplined benefit–risk assessment, feasibility evaluation, and contingency planning.
- Oversee functional resourcing and provide budget input across Clinical Science and early development activities.
- Build strong external relationships with CROs, investigators, and scientific experts.
- Represent Clinical Development in regulatory interactions and business development diligence, as appropriate.
- Lead through a combination of direct authority and strong matrix influence across R&D, Medical Affairs, and enterprise partners.
Education
- MD, PhD, or equivalent terminal degree preferred.
- Advanced degrees such as PharmD or MS considered with substantial clinical development leadership experience.
- 15+ years of progressive experience in pharmaceutical or biotechnology clinical development.
- Demonstrated leadership in Clinical Science and/or early clinical development.
- Proven success building and scaling teams and operating models in matrixed environments.
- Experience influencing portfolio decisions and serving in therapeutic area or program leadership roles.
- Strong understanding of regulatory, biostatistical, and translational science principles.
Skills
- Enterprise leadership with strong systems thinking
- Scientific and medical credibility across disciplines
- Executive judgment in complex and uncertain environments
- Effective matrix leadership and governance presence
- Ability to seamlessly balance strategic leadership with hands-on execution
Additional Requirements