Clinical Development Medical Director- Pain

Vertex Inc. • Boston, MA

5d • $240,000 - $360,000 • Hybrid

About The Position

The Clinical Development Medical Director serves as the Medical Lead for Vertex clinical trials, collaborating with cross-functional multidisciplinary study teams on 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 works across multiple trials in all phases of clinical development and may participate in selected additional clinical development projects.

The position develops key study documents, supports regulatory submissions, provides scientific and clinical input to study-related documents and analysis plans, and represents Vertex to external medical personnel in protocol development and study conduct. It works closely with internal groups such as Regulatory Affairs and Clinical Operations to support assigned studies.

Requirements

• MD, DO, or equivalent ex-US medical degree.
• Board certification or eligibility in a medical, pediatric, or surgical subspecialty.
• Typically 10 years of basic or clinical research experience in an academic or industry 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 work collaboratively in a fast-paced, team-based, matrix environment and independently as appropriate.
• Effectiveness building alliances across functions based on end-to-end drug development thinking and experience.

Nice To Haves

• Board certification or eligibility in a specialty field is highly desired.

Responsibilities

• Lead development of study protocols, investigator brochures, clinical development plans, and other key study documents with other line functions and minimal guidance.
• Serve as Medical Monitor for assigned clinical studies.
• Serve on cross-functional Study Execution Teams for assigned trials and collaborate with team members to achieve efficient, high-quality study execution.
• Participate in preparing regulatory documents for submissions, 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 development of clinical protocols and study conduct.
• Perform other duties as assigned related to clinical programs.

Benefits

• Annual bonus and 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