Director, Clinical Development, Oncology
About The Position
Moderna is seeking a board-certified medical hematologist/oncologist with pharmaceutical experience to lead Clinical Development for one or more of their immuno-oncology-based development programs. Experience in late phase drug development is a plus. This role will report to the Executive Director, Clinical Development, Oncology and have direct medical responsibility for the clinical development programs including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring all in close collaboration with relevant internal and external pharmaceutical partners and Clinical Research Organizations. There is approximately 10% travel expected as part of this role. The successful candidate will thrive in a proactive can-do culture and enjoy working across the full range of clinical development activities for the ground-breaking, mRNA-based immuno-oncology-based new drug candidates in addition to being a highly effective internal and external team player and terrific communicator and collaborator.
Requirements
- Medical Doctor (M.D.), or non-US equivalent of M.D. degree with relevant hematology and/or oncology in an academic or hospital environment.
- Completion of a residency program strongly preferred.
- Completion of a pediatric or medical hematology and/or oncology fellowship is desirable.
- Minimum 3 years’ experience in immune-oncology or oncology clinical drug development, preferably in a pharmaceutical or biotechnology company, as well as significant knowledge and experience in the design and execution of clinical trials.
- Background working in development programs that heavily integrate translational medical approaches a must.
- Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Outstanding verbal and written communication skills, in addition to excellent organizational skills.
- Understanding of the entire drug development process, including clinical and non-clinical study design and execution.
- Experience in early-stage programs.
- Experience in leading the selection and oversight of CROs and other vendors.
- Oversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct.
- Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world.
- Experience in regulatory cGCP inspections and audits.
Nice To Haves
- Experience in late phase drug development is a plus.
Responsibilities
- Provide clinical leadership for individual programs at the Project Team Level, including serving as key representative for clinical development/medical strategy areas both internal and external facing (e.g., CRO, KOL and clinical site staff).
- Serve as cross-functional leader on all Medical and clinical work streams including clinical pharmacology, statistics, clinical operations, regulatory affairs, and preclinical science and translational medicine.
- 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, and other program documents. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
- Act as subject matter expert on all clinical and medical strategic initiatives for their programs.
- Primary responsibility for preparations of external meeting abstracts, posters, presentations related to clinical trial data.
- Consult with external and internal subject matter experts to agree go/no-go development decision criteria.
- Implement safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
- Lead clinical sections of regulatory documents (e.g., IND, DMF and BLA/NDA), prepare for meetings with FDA and healthcare authorities and organize and prepare for Advisory Board meetings.
- Implementation of clinical trials with adherence to cGCP and FDA Regulatory compliance.
- May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
- Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization.
- Represent the Company externally to Investigators, trial site administrators and sit on Joint Development Committee for programs performed in collaboration with other Pharma companies.
Benefits
- Competitive healthcare, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investments to help you plan for the future
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
