Director, Clinical Development, Rare Diseases
Moderna is seeking a high-energy, Board Certified/ Board Eligible physician for its metabolic rare diseases development programs. This role will report to the Sr. Director, Clinical Development, Rare Diseases, and have direct medical responsibility for 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 Moderna teams as well as external pharmaceutical partners and Clinical Research Organizations.
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 new drug candidates, in addition to being a highly-effective internal and external team player and terrific communicator and collaborator.
- Leadership of Early Development Program Team(s) and the evolving program strategy, incorporating appropriate external expertise
- Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for Clinical Development Plans (CDP)
- Establish appropriately clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP.
- Ensure smooth transition from an early preclinical discovery phase to a full clinical development program
- Provide clinical leadership for rare diseases, serve as a 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 medical and clinical work streams including clinical pharmacology, statistics, clinical operations, regulatory affairs, and translational medicine
- Act as subject matter expert on clinical and medical strategic initiatives
- Design and develop clinical development plans, study protocols and interpret clinical study data, including review of the pre-clinical package
- 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
- Leadership of metabolic rare diseases clinical trials with adherence to cGCP and FDA Regulatory compliance
- Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization
- M.D. with strong leadership skills and proven biopharmaceutical industry experience managing early and late stage development programs
- 3+ years experience in the biotechnology or pharmaceutical industry, including direct experience leading the delivery of an IND or CTA.
- Strong scientific research background in areas of focus; experience in other aspects of preclinical development
- Demonstrated track record in leading cross-functional teams and work streams (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
- An “A” record of accomplishment including developing, planning, designing, and executing clinical studies leading to the successful registration of therapeutics
- Experience in supporting regulatory submissions to the FDA and other regulatory agencies
- Thorough understanding of the drug development process, including GCP, and experience in clinical operations
- Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders
- Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
- Highly developed understanding of the external market place and scientific literature to identify long-term benefits for unmet patients' needs
- Demonstrated scientific accomplishment enabling rapid understanding of the mRNA technology
- Marked proficiency in clinical/medical writing and verbal communication
- Understanding of the entire drug development process, including clinical and non-clinical study design and execution
- Experience in leading the selection and oversight of CROs and other vendors
- Qualified to lead 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
- Creative, capable, problem-solver
- Track record of dogged pursuit of solutions for patients
- Demonstrated track record of living values core to Moderna
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.