Medical Director, Endocrinology
About The Position
Vertex is seeking a pediatric or adult endocrinologist to contribute clinical expertise to the development of atumelnant, an investigational once-daily oral ACTH receptor antagonist in Phase 3 development for congenital adrenal hyperplasia and Phase 2 development for Cushing’s syndrome. The Clinical Development Medical Director will serve as Medical Lead for Vertex clinical trials, working with cross-functional, multidisciplinary study teams on clinical-trial strategy, design, and execution. The role also serves as Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials across all phases of clinical development and may participate in other selected clinical-development projects. Vertex recently completed its acquisition of Crinetics Pharmaceuticals, adding commercial and pipeline endocrinology programs to its innovation portfolio. The portfolio includes PALSONIFY® (paltusotine), an oral therapy for acromegaly, and atumelnant. Vertex is a global biotechnology company that invests in scientific innovation to create medicines for people with serious diseases and conditions.
Requirements
- MD, DO, or equivalent ex-US medical degree.
- Typically 10 years of basic or clinical research experience in an academic or industrial setting, or an equivalent combination of education and experience.
- Experience analyzing research data and publications.
- Working knowledge of biostatistics, GCP, scientific and clinical research methods, and clinical study design.
- Experience designing, executing, and analyzing clinical trials.
- Excellent oral and written communication skills.
- Ability to collaborate in a fast-paced, team-based, matrix environment and function independently as appropriate.
- Effectiveness building alliances across functions based on end-to-end drug-development thinking and experience.
- Board certification or eligibility in a medical, pediatric, or surgical subspecialty.
Nice To Haves
- Board certification or eligibility in a specialty field is highly desired.
- Pediatric or adult endocrinology expertise.
Responsibilities
- Lead the development of study protocols, investigator brochures, clinical development plans, and other key study documents in conjunction with other functions and with minimal guidance.
- Serve on cross-functional Study Execution Teams for assigned trials and work with team members to achieve efficient, high-quality study execution.
- Participate in preparing regulatory documents supporting submissions, including clinical sections of INDs and CTAs, safety reports and annual reports, responses to regulatory authorities and Ethics Committees/IRBs, and other appropriate documents.
- Provide scientific and clinical input to study-related documents and analysis plans, including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports.
- Act as liaison between Translational Medicine/Clinical Development and other Vertex groups, such as Regulatory Affairs and Clinical Operations, for assigned studies.
- Represent Vertex to outside medical personnel in the development of clinical protocols and study conduct.
- Perform other duties related to clinical programs as assigned.
- Serve as Medical Monitor and monitor the safety of enrolled subjects on assigned trials.
Benefits
- Annual bonus eligibility
- Annual equity awards
- Medical benefits
- Dental benefits
- Vision benefits
- Generous paid time off, including a week-long company shutdown in the summer and winter
- Educational assistance programs, including student loan repayment
- Commuting subsidy
- Matching charitable donations
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
