Associate Medical Director, Endocrinology

Vertex Inc. • Boston, MA

13d • $204,000 - $306,000 • Hybrid

About The Position

Vertex is seeking a pediatric or adult endocrinologist to contribute clinical expertise to 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 Associate Medical Director serves as the Medical Lead for clinical trials, partnering with cross-functional teams on trial strategy, design, execution, and reporting. The role provides oversight and accountability for assigned studies and serves as the internal primary Medical Monitor, accountable for enrolled-subject safety and scientific integrity. The incumbent may also support other projects within the clinical development program.

The position develops and reviews clinical and regulatory study materials, works on cross-functional Study Execution Teams, and provides scientific and clinical input across study documents and analysis plans. It also liaises with internal Vertex functions and represents Vertex to external medical personnel during protocol development, study conduct, and reporting of study results.

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The role is hybrid-eligible or on-site eligible: employees may work remotely up to two days per week in the hybrid designation, or work on-site five days per week with ad hoc flexibility. The position offers a base salary range of $204,000–$306,000 and is eligible for an annual bonus and annual equity awards.

Requirements

• MD, DO, or equivalent ex-US medical degree.
• Typically eight years of basic or clinical research experience in an academic or industry setting, or an equivalent combination of education and experience.
• Strong oral and written communication skills.
• Ability to collaborate in a fast-paced, team-based matrix environment and function independently as appropriate.
• Pediatric or adult endocrinology expertise is sought for the clinical development program.

Nice To Haves

• Global clinical research experience and experience interacting with regulatory authorities.
• Working familiarity with research data analysis, biostatistics, pharmacology and pharmacokinetics, Good Clinical Practice (GCP), clinical study design, ethics committee/IRB review, manuscript preparation, abstracts/posters, oral presentations, and overall drug/device clinical development.
• Board certification or eligibility and clinical training in a relevant medical specialty.

Responsibilities

• Participate in developing study protocols, Investigator’s Brochures, Clinical Development Plans, and other key documents with other line functions and 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 submission documents, including clinical sections of INDs and CTAs, IND 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 Clinical Development and other internal Vertex groups, such as Regulatory Affairs and Clinical Development Execution, for assigned studies.
• Represent Vertex to outside medical personnel in clinical protocol development, study conduct, and external reporting of study results.
• Perform other duties related to other aspects of Clinical Development as assigned.
• Serve as Medical Lead for clinical trials, contributing to trial strategy, design, execution, and reporting.
• Provide oversight and accountability for assigned studies and act as internal primary Medical Monitor for subject safety and scientific integrity.

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