Executive Director, Clinical Development, Oncology

Role Overview

Senior level clinical development physician (M.D.) with deep oncology drug development experience in the biopharma industry to lead clinical development for one or more groundbreaking oncology programs. The role has direct medical responsibility for key clinical development programs, including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring in close collaboration with internal and external pharmaceutical partners and Clinical Research Organizations.

• Provide integrated clinical development strategy to support the creation and management of the Clinical Development Plan (CDP).
• Integrate scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP.
• Generate data and evidence required to determine a medicine’s potential efficacy, safety profile, product differentiation and value to patients in the shortest possible timeframe.
• Establish expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP.
• Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
• Contribute to and partner on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development.
• Play an active role in the technical and leadership development of Clinical Sciences staff through coaching and mentoring, with potential direct line management.

• Employ visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy and lead selected clinical development projects for products or franchises of compounds.
• Lead and positively interface with diverse scientific external experts (regulators, payors, CROs, consultants, investigators) to deliver integrated clinical development strategy aligning to business strategy and achieving mutual goals related to patient need.
• Integrate inputs from across disciplines to contribute to the Target Product Profile and be accountable for the clinical components.
• Be accountable for risk/benefit of the asset and make decisions that balance risk/benefit at the project level with clear understanding of impact on study/project approvals; mitigate risk where appropriate.
• Assess and predict when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential benefit.
• Anticipate problems and proactively seek input from other teams to solve study and/or project related problems by using scientific/operational expertise.
• Accountable for the evaluation of clinical study/program probability of technical success.

• Drive end‑to‑end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management.
• Lead clinical development discussions at regulatory interactions and clinical components of submissions (IND, BLA, MAA) including briefing documents, presentations, addressing questions and responses.
• Deliver value and access insights to inform medical strategy, expand market access, and address unmet patient need.

• Overcome obstacles by experimenting with and adopting new ways of working, including digital tools and technology.
• Champion implementation of innovative methods and processes within clinical development and gain stakeholder support; encourage others to think differently and generate business solutions.

• Medical oncologist with 10+ years’ experience in clinical development, with at least 5 years in the biopharmaceutical industry, or M.D. with at least 8 years of experience in oncology drug development in the biopharmaceutical industry.
• Experience in immuno‑oncology or oncology clinical drug development and significant knowledge in…