Executive Director, Clinical Development, Oncology

The Role

Moderna is seeking a 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 of our groundbreaking oncology development programs. This role will have 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, all in close collaboration with relevant internal and external pharmaceutical partners and Clinical Research Organizations.

The successful candidate will thrive in a proactive can‑do culture and enjoy working across the full range of clinical development activities for new mRNA‑based oncology drug candidates, in addition to being a highly‑effective internal and external thought leader, communicator, and collaborator.

• Provide integrated and innovative clinical development strategy to support the creation and management of the Clinical Development Plan (CDP) for assets in development.
• 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 the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient 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 for a drug(s) or program(s). Lead selected clinical development projects for products/franchise of compounds.
• Lead and positively interface with, and influence across, a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy that aligns to the business strategy and achieves mutual goals related to patient need.
• Integrate inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to the Target Product Profile. Accountable for the clinical components of the Target Product Profile.
• Accountable for risk/benefit of the asset. Actively lead and make decisions that balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; take action to mitigate risk where appropriate.
• Assess and predict when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit.
• Anticipate problems and proactively seek input from other teams’ members/functional lines within R&D. Use scientific/operational expertise to solve study and/or project related problems.
• Accountable for the evaluation of clinical study/program probability of technical success.

• Drive the 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 the submissions (e.g. IND, BLA, MAA) including briefing documents, presentations, addressing questions and responses.
• Deliver value and access insights to inform medical strategy, expand market access and to address unmet patient need.

• Overcome…