Medical Director, Endocrinology

Vertex Pharmaceuticals • Boston, MA

14d

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 development for congenital adrenal hyperplasia and Cushing’s syndrome. The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, collaborating 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 across multiple trials in all phases of clinical development and may participate in other selected clinical-development projects.

The position develops key study documents, contributes scientific and clinical input to study materials and analysis plans, supports regulatory submissions, and represents Vertex in external medical interactions related to clinical protocols and study conduct. It requires effective collaboration in a fast-paced, matrixed environment as well as the ability to work independently.

Requirements

• MD, DO, or equivalent ex-US medical degree.
• Board certification or eligibility in a medical, pediatric, or surgical subspecialty; board certification or eligibility in a specialty field is highly desired.
• 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, Good Clinical Practice (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 in building cross-functional alliances using end-to-end drug development thinking and experience.

Nice To Haves

• Pediatric or adult endocrinology expertise.

Responsibilities

• Lead development of study protocols, Investigator Brochures, Clinical Development Plans, and other key study documents in conjunction with other functional teams and with minimal guidance.
• Serve on cross-functional Study Execution Teams for assigned trials and work with team members to support efficient, high-quality study execution.
• Participate in preparing regulatory-submission documents, including clinical sections of INDs and CTAs, safety 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 internal Vertex groups, including Regulatory Affairs and Clinical Operations, for assigned studies.
• Represent Vertex to outside medical personnel in the development of clinical protocols and study conduct.
• Serve as Medical Monitor and monitor the safety of enrolled subjects on assigned trials.
• Perform other duties related to clinical programs as assigned.

Benefits

• Annual bonus eligibility
• Annual equity awards
• Medical, dental, and 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree