Clinical Development Medical Director-Nephrology
$204,000–$306,000 year
HybridBoston, Massachusetts, United States
Job Summary
Develop study protocols, Investigator's Brochures, and clinical development plans with minimal guidance while serving as the internal primary Medical Monitor for assigned trials. Lead cross-functional Study Execution Teams to ensure efficient, high-quality study execution and prepare regulatory documents including IND safety reports, annual reports, and responses to authorities. Provide scientific input to analysis plans, informed consent forms, and clinical study reports, acting as the liaison between Clinical Development and internal groups like Regulatory Affairs. Represent Vertex to outside medical personnel during protocol development, study conduct, and external reporting of results. This role supports clinical development programs for transformative medicines targeting serious genetic diseases and other serious conditions, including APOL1-mediated kidney disease and acute pain.
Required Qualifications
- MD, DO or equivalent ex-US medical degree
- Typically requires 8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience
Desired Qualifications
- Board certification/eligibility, as well as clinical training in a relevant medical specialty
- Global clinical research experience
- Experience interacting with regulatory authorities
- Working familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics
- International standards for Good Clinical Practice (GCP)
- Clinical study design
- Ethics committee/Institutional Review Board review
- Preparation of manuscripts, abstract/posters, and oral presentations
- Overall drug/device clinical development
- Strong oral and written communication skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
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