Sr. Director, Clinical 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 a 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. 

This role will report to the Vice President Therapeutic Area Head for Rare Disease. The position will be based at Moderna’s Cambridge, MA headquarters.

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:

• Contribute to clinical program strategy to support the creation and implementation of the Clinical Development Plan for one or more assets in development (preclinical and clinical stages).

• Lead the generation of data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patients in the shortest possible timeframe.

• Develop and maintain relationships with program counterparts in Clinical Operations, Data Management, Safety, Statistics, Research, Regulatory, and Commercial.

• Act as the medical monitor for one or more trials in collaboration with CRO/key vendors, overseeing participant safety.

Scientific Leadership, Direction and Strategy:

• Serve as the primary medical lead/expert for assigned trials with a hands-on approach; direct oversight of the planning, execution, and management in collaboration with cross-functions.

• Lead the review and interpretation of clinical trial data (eg, safety, efficacy, PK/PD), to make informed decisions throughout the drug development process; collaborate in the timely review of medical coding and statistical data analysis activities to ensure data accuracy, quality and integrity.

• Lead/author/contribute to the development of clinical documents to include but not limited to clinical protocols, clinical study reports, medical monitoring plans, biomarkers strategies, statistical analysis plans, pharmacy manual, study-specific plans, informed consent forms.

• Contribute to operational activities related to successful clinical trial execution including input into country/site feasibility assessments, study site support/communication, monitoring and compliance with required documentation; ensure that medically related Trial Master File documentation is properly maintained.

• Proactively identify project risks with cross-functional input and make decisions/take action using scientific/operational expertise to resolve issues ensuring that any potential delays are fully mitigated; maintain detailed timelines for all medical deliverables; consistent & regular tracking of project timelines to allow full transparency to the senior leadership.

• Accountable for clinical sections of regulatory documents like IBs, briefing books, safety updates, submission documents (e.g., MAA, BLA, IND), responses to Health Authorities questions and for clinical development discussions at regulatory interactions.

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

• Serves as a key external liaison/spokesperson of the clinical program in interactions across a diverse range of scientific external experts (e.g., investigators, regulators, CROs, consultants) to deliver thorough clinical study plans.

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

• Ensure that the highest quality, ethical & professional values are demonstrated in all aspects of the work; ensure compliance with corporate policies and procedures, in addition to all related healthcare laws and regulations.

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

• MD degree with completed residency/fellowship training is required.

• 5+ years of direct clinical development experience in industry (biotech/pharma) conducting Phase 1-3 studies is required. Rare disease (Pediatrics) experience highly preferre