Senior Director, Oncology Clinical Development, Early Phase

About the Role Moderna is seeking an experienced oncology drug development leader to drive early-phase clinical development for one or more mRNA-based precision immunotherapies. The role reports to the Head of Early Clinical Development, Oncology and has medical responsibility for clinical development programs, including creating development plans, designing studies, writing protocols, and ensuring timely execution and medical monitoring in collaboration with internal/external partners and CROs.

What You'll Do

• Collaborate in the development and execution of the Clinical Development Plan (CDP) for assigned oncology assets.
• 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, 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.
• Collaborate effectively with program counterparts in Translational Medicine, Pharmacometrics, Research, Biostatistics, Clinical Operations, Regulatory, Commercial, and other functional areas as needed.
• Contribute to and partner with the development of strategic initiatives, such as organizational initiatives within Clinical Development.
• Play an active role in the technical and leadership development of Clinical Scientists.
• Scientific Leadership, Direction and Strategy: Employ visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s). Leads selected clinical development projects for products/franchise of compounds.
• Able to lead and influence across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) to deliver integrated clinical development strategy aligned to business goals and patient needs.
• Integrates 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; acts to balance risk/benefit at the project level with impact on approvals; mitigate risk where appropriate.
• Evaluates therapies designed for one patient population/indication for potential use in alternative scenarios to broaden patient benefit.
• Anticipates problems and proactively seeks input from team members across R&D. Uses scientific/operational expertise to solve study and/or project-related problems.
• Accountable for the evaluation of clinical study/program probability of technical success.
• Study & Program Design and Evidence Generation: Drives the end-to-end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and lifecycle management.
• Leads clinical development discussions at regulatory interactions and clinical components of submissions including briefing documents, presentations, addressing questions and responses.
• Delivers value and access insights to inform medical strategy, expand market access and address unmet patient need.
• Creating Innovative Scientific and Technical Solutions: Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology. Champions implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions.

What We're Looking For

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant hematology and/or oncology in an academic or hospital environment.
• Experience in oncology drug development demonstrated by at least 3 years in the biopharmaceutical industry. In exceptional cases, at least 5 years of experience as an early-phase clinical trialist in academia would be considered.
• Medical oncology and/or hematology fellowship training is preferred.
• Experience in oncology and/or hematology immunotherapeutics is preferred.
• Experience in conducting translationally rich oncology and/or hematology clinical trials is highly valued.
• Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
• Outstanding verbal and written communication skills, in addition to excellent organizational skills.
• Understanding of the entire drug development process, including clinical and non-clinical study design and execution.
• Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.
• Ability to oversee activities leading to internal cGCP audits and regulatory interactions.

Nice to Have

• Oncology/hematology fellowship training is preferred.
• Experience in oncology and/or hematology immunotherapeutics is preferred.
• Experience in translationally rich oncology/hematology clinical trials is highly valued.

Compensation & Benefits

• Not disclosed in the posting.