Executive Director, Clinical Development, Oncology

Role Overview

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.

Lead selected clinical development projects for products/franchise of compounds.

Influence across a diverse range of scientific external experts (regulators, payors, CROs, consultants, investigators) to deliver integrated clinical development strategy aligned to the business strategy.

Integrate inputs from across disciplines to contribute to the Target Product Profile and be accountable for the clinical components of this profile.

Ascertain risk/benefit, balance decisions, and take actions to mitigate risk where appropriate.

Assess when therapies can be used in alternative scenarios to broaden patient benefit.

Proactively solve study and/or project related problems and contribute to evaluation of clinical study/program probability of technical success.

Lead clinical development discussions at regulatory interactions and prepare submissions (IND, BLA, MAA) including briefing documents and responses.

Deliver value and access insights to inform medical strategy and market access.

Champion innovative methods and processes within clinical development and encourage others to think creatively.

• Medical oncologist with more than 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 and experience leading the design and execution of clinical trials.
• Experience leading cross‑functional teams and work streams (translational medicine, biostatistics, regulatory, pre‑clinical pharmacology, pharmaceutical sciences).
• Understanding of the entire drug development process and clinical/non‑clinical study design and execution.
• Thorough understanding of clinical research methodology and biostatistics principles to facilitate innovative and efficient clinical trial designs.
• Attention to detail, internal drive and sense of urgency to achieve team and program goals.
• Excellent verbal and written communication…