Sr. Director, Clinical Development – Autoimmune, Cardiovascular (CV), Pulmonary and Rare Diseases

The Role:

Programs in Therapeutics Development are a key part of Moderna’s portfolio. Comprising a dynamic & collaborative community of clinical development physicians and scientists across Rare and Autoimmune, Diseases, we are driving scientific innovation to deliver transformational medicines.

Moderna is seeking an MD with experience in rare disease/immunology clinical development to lead the clinical strategy for one or more assets within the Therapeutic portfolio and oversee a clinical team accountable for trials to execute the strategy. This role offers you the opportunity to utilize advanced scientific and statistical principles and digital technology in collaboration with your peers to help build Moderna’s pipeline.

This role will report to Moderna’s Clinical Head for Therapeutics (Rare Disease, Autoimmune or Exploratory Disease). The position is based at one of Moderna’s offices in: Cambridge, MA; Princeton, NJ; Bethesda, MD. 

The successful candidate is driven, curious, and collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based therapeutics. The candidate must have excellent oral and written communication skills, and a collaborative way of working. 

Here’s What You’ll Do:

• Providing integrated and innovative clinical development strategy to lead the creation and management of the Clinical Development Plan (CDP) for an asset 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, 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 and potential direct line management

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

• 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 innovativ