Early Development Associate Medical Director

Vertex Inc. • Boston, MA

1d • $204,000 - $306,000 • 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 oversees and is accountable for the study as a whole and acts as the internal primary Medical Monitor, accountable for monitoring the safety of enrolled subjects and ensuring scientific integrity. The incumbent may also support other projects within the clinical development program.

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 work collaboratively in a fast-paced, team-based matrix environment and 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.

Responsibilities

• Participate, with minimal guidance, in developing study protocols, Investigator's Brochures, Early Development Plans, and other key documents in conjunction with other line functions.
• 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 for 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 a liaison between Early Development and other internal Vertex groups, including 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.

Benefits

• Annual bonus and annual equity awards; some roles may also be eligible for overtime pay.
• 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