Early Development Associate Medical Director

Vertex Pharmaceuticals • Boston, MA

4d • Hybrid

About The Position

The Early Development Associate Medical Director serves as the Medical Lead for Phase 1 clinical trials, working 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 monitoring enrolled subjects’ safety and ensuring scientific integrity. The incumbent may also support other projects within the clinical development program.

The position contributes to the development of study protocols, Investigator’s Brochures, Early Development Plans, regulatory submissions, study-related documents, and analysis plans. It serves on cross-functional Study Execution Teams, liaises between Early Development and other internal Vertex groups, and represents Vertex to outside medical personnel in protocol development, study conduct, and external reporting of study results. Other duties may be assigned in support of Early Development.

Vertex describes a culture that values continuous learning and thoughtful adoption of advances in AI, technology, automation, and industry trends to improve decision-making, innovation, efficiency, and patient outcomes. 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. Flex status is subject to company policy and may change.

Requirements

• MD, DO, or equivalent ex-US medical degree.
• Typically 8 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.
• Working familiarity with research-data analysis, biostatistics, pharmacology and pharmacokinetics, Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, manuscript preparation, abstracts/posters, oral presentations, and overall drug/device clinical development.

Nice To Haves

• Global clinical research experience and experience interacting with regulatory authorities.
• Board certification or eligibility and clinical training in a relevant medical specialty are highly desired.

Responsibilities

• Participate in developing study protocols, Investigator’s Brochures, Early 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 support efficient, high-quality study execution.
• Prepare regulatory documents supporting submissions, 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 Early Development and internal groups such as Research, Biomarkers, Regulatory Affairs, and Global Clinical Operations for assigned studies.
• Represent Vertex to outside medical personnel in developing clinical protocols, conducting studies, and externally reporting study results.
• Perform other duties related to other aspects of Early Development as assigned.
• Serve as the Medical Lead for Phase 1 clinical trials and provide study oversight and accountability.
• Serve as the internal primary Medical Monitor, monitoring enrolled subjects’ safety and ensuring 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).
• Some roles may be eligible for overtime pay in accordance with federal and state requirements.

What This Job Offers

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