Medical Director, Clinical Development (Therapeutics Development, Rare Disease)

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 Autoimmune, Cardiovascular, Pulmonary, Hematology, and Rare Diseases, we are driving scientific innovation to deliver transformational medicines.

Moderna is seeking an MD with experience in clinical development to contribute to the clinical strategy for rare disease 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. At least two years of industry experience is required. 

This role will report to Moderna’s Therapeutic Area Head for Rare Disease. The position can be based at Moderna’s Cambridge, MA site (preferred), or at Moderna’s satellite sites in Princeton, NJ and Bethesda, MD.

The successful candidate is driven, curious, 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:

• Contributing to the integrated and innovative clinical development strategy to support the creation and management of the Clinical Development Plan (CDP) for an asset in development

• 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

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

• Serving as medical monitor for one or more trials in collaboration with key vendors, ensuring participant safety throughout

Scientific Leadership, Direction and Strategy:

• Interacting across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver thorough clinical study plans

• Accountable for risk/benefit of the asset at study level.  Actively leads and makes decisions which balance risk/benefit at the study level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriate

• Anticipating study level 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

• Drives the study design to support the clinical development strategy and ensures the study optimizes scientific value, patient focus and feasibility of execution

• Work closely with clinical operations colleagues for efficient delivery of clinical trials

• Prepares for 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

• Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology

• Open to implementation of innovative methods and processes within clinical trial designs and thinks differently to come up with business solutions

Here’s What You’ll Bring to the Table:

• MD degree with completed residency/fellowship training

• At least 2 years of direct clinical development experience  in industry (biotech/pharma) or regulatory body (e.g, FDA).  Rare disease experience preferred.

• Ability to thrive in a fast-paced environment

• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals

• Excellent analytical, problem-solving and strategic planning skills

• Experience in clinical drug development with an understanding of multiple diseases, the underlying biology and potential therapeutic targets as well as current and future potential treatment options

• Clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.

• Some experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication

• Ability to maximize and integrate genetic data to