Senior Medical Director, Clinical Development, Oncology

The Role:

Moderna is seeking a Senior Medical Director with pharmaceutical experience to lead Clinical Development for one or more of their immuno-oncology-based development programs. This role will report to the Head of Emerging Oncology for Moderna and have direct medical responsibility for the 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 fast-paced, proactive, can-do culture and enjoy working across the full range of clinical development activities to translate mRNA science into new immuno-oncology drug candidates for first-in-human clinical trials. the clinical with In addition, the ability to communicate with diverse internal and external stakeholders as well as engage in productive and seamless collaboration will enable success in this role.

Here’s What You’ll Do:

• Providing integrated and innovative clinical development strategy to support the creation and management of the Clinical Development Plan (CDP) for one or more assets in development

• Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP

• Generating 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

• Establishing expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP

• Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Translational Medicine, Clinical Operations and Statistics

• Contributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development

• Playing an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring

Scientific Leadership, Direction and Strategy:

• Employs 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

• Leading and positively interfacing with and influencing 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

• Integrating 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

• Assessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit

• Anticipating problems and proactively seeking input from other teams’ 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