VP, Clinical Development, Rare Disease

at  Moderna

HERE’S WHAT YOU’LL BRING TO THE TABLE:

Medical Doctor (M.D.) or non-US equivalent of M.D. degree with relevant internal medicine training. Completion of a residency program strongly preferred.
Minimum 12 years’ experience therapeutics clinical development, preferably in a pharmaceutical or biotechnology company, as well as significant knowledge and experience in the design and execution of clinical trials from phase 1 to phase 3.
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Experience in innovation in clinical development, including clinical trial design, use of digital technology, and understanding of genetics in drug development
Understanding of the entire drug development process, including clinical and non-clinical study design, innovative study design platforms, use of digital and importance of target product profile.
Broad understanding of local and global Pharmaceutical industry, competitive landscape, how end-to-end life and revenue cycles operate.
Demonstrated ability to lead and inspire teams and allocate resource strategically and according to portfolio priorities.
Proven ability to manage and develop self and work collaboratively with others to deliver innovative and creative results and solutions. Includes leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical, medical and epidemiology)
Superior stakeholder management skills, across scientific, academic, regulatory and political communities to identify and achieve mutual goals for the well-being of patients and our communities.
Thorough command of ICH and GCP guidelines to ensure the appropriate ethical conduct of global clinical studies.
Ability to thrive in a fast paced, rapidly evolving environment with little direction.
Embodies Moderna’s core values of Bold, Relentless, Curious and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community

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 identification, recruitment, development and retention, to support the pipeline and marketed portfolio.