VP, Clinical Development, Rare Disease

The Role:

Moderna is seeking a physician with internal medicine training with pharmaceutical experience to lead Clinical Development for our expanding Rare Disease programs.  mRNA has promise in several areas of Internal Medicine, including Cardiovascular, Pulmonary, Hematology and invasive indications. We seek an agile clinical developer to lead as we interrogate and prosecute those diseases where mRNA has transformative potential.

Experience in a broad therapeutic range of drug development and in mid and late-stage development is a plus. This role will report to the SVP, Head of Therapeutics Development for Moderna and have direct medical responsibility for the clinical development of our Rare Disease Therapies portfolio, including accountable for the overall clinical development plans, innovative clinical studies and protocols, and for ensuring timely execution and medical monitoring all in close collaboration with relevant internal and external pharmaceutical partners, Clinical Research Organizations and regulatory agencies. The position is based in Cambridge, MA headquarters. There is approximately 10% travel expected as part of this role.

The successful candidate is able to work independently and thrive in a proactive can-do culture and team milieu to lead the clinical development activities for mRNA-based therapies for our current Rare Disease programs while leveraging success in those to catalyze development across the most promising Rare Disease therapies. You will work closely with colleagues in Therapeutics Development including autoimmune disease, CV/Emerging, and immuno-oncology, while also having a change to interact with colleagues in infectious disease. The candidates will be a highly effective internal and external team player and terrific communicator and collaborator.

Here’s What You’ll Do:

• Provide clinical leadership for the Rare Disease Therapy programs across projects, while deeply involved at each project team level, including ensuring most streamlined and innovative clinical development/medical strategy areas. Utilize both internal and external inputs (e.g., academic thought leaders, research leads, regulatory authorities, contract research organizations, investigators and patient groups)

• Drive innovation in design of clinical development plans and study protocols within the disease area, accessing world-class expertise through external and internal collaboration, harnessing digital, technological and statistical tools and with specific accountability to support early-stage programs in the therapeutic area by bringing in disease insights and clinical research expertise.

• Responsible for the design and development of clinical development plans, study protocols and interpretation and analysis of clinical study safety and efficacy data, including review of the pre-clinical package.  Responsible for Investigator Brochures, Clinical Study Reports, regulatory submissions and responses pertaining to clinical development, and other program documents.  Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.

• Ensure high quality and timely interpretation of clinical data, including through meeting abstracts, posters, presentations, and publications for internal management review and external scientific/clinical meetings.

• Provide Medical Governance with specific accountability for managing and mentoring clinical staff in the disease area line and ensure proper training and compliance with internal and external policies, guidance, laws and codes. Ensure clinical trials adhere to cGCP and compliance with FDA, EMA and other relevant national regulatory agency requirements. 

• Develop risk-based safety monitoring of clinical trials and implement safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.

• Ensure high quality clinical sections of regulatory documents, prepare for meetings with FDA and healthcare authorities and organize and prepare for Advisory Committee meetings

• May participate in due diligence or other business development activity.

• Contribute in partnership with Research and Development and Technical Development colleagues to design and implement translational strategies.

• Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development, Research and the broader Moderna organization

• Represent Moderna externally to investigators, trial site administrators, external funders and sit on Joint Development Committee for programs performed in collaboration with other Pharma companies.

• Develop and maintain Clinical Development excellence in the therapeutic area through talent identificati