Moderna is seeking an experienced oncology drug developer lead Clinical Development for one or more mRNA-based precision immunotherapies. The role will report to the Head of Early Clinical Development, Oncology and have direct medical responsibility for 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 partners and Clinical Research Organizations.
Requirements
- 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
- Contributes to and partners with the development of strategic initiatives, such as organizational initiatives within Clinical Development
- Plays 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) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need
- 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. Actively leads and makes decisions which balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriate
- Evaluates therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit
- Anticipates problems and proactively seeks input from other team members/functional lines within 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 successful lifecycle management
- Leads clinical development discussions at regulatory interactions and clinical components of the submissions (e.g. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses
- Delivers value and access insights to inform medical strategy, expand market access and to 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
Benefits
- Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities to help you plan for the future
- Location-specific perks and extras
