Clinical Development Senior Medical Director (Nephrology)

Vertex Pharmaceuticals • Boston, MA

123d • $280,600 - $420,900

About The Position

The Senior Medical Director will lead the clinical development strategy of povetacicept in IgA nephropathy, work with cross-functional multidisciplinary teams to define overall asset strategy as well as clinical trials strategy, design and execution, and may serve as the Medical Lead for clinical trials that will be conducted with these compounds.

Requirements

• Global clinical research experience, and experience interacting with regulatory authorities is highly desired
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• Ability to work independently to resolve challenges
• Enterprise-wide thinking and ability to work in ambiguity
• Ability to ensure the completeness of team work
• Excellent oral and written communication skills
• MD, DO or equivalent ex-US medical degree
• Typically requires 12 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experience

Nice To Haves

• Board certification/eligibility in nephrology is highly desired

Responsibilities

• Defines a clinical development strategy and prepare the clinical development plans, in conjunction with other relevant functional areas
• Participates in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance
• Leads the Project Team, and works with cross-functional team members to define a project strategy and ensure execution against approved strategy
• Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate
• Interfaces with regulatory authorities as appropriate
• Monitors and/or oversees medical monitoring of clinical studies
• Participates in business development and strategic planning activities
• Acts as liaison between clinical development and other internal groups at Vertex for assigned studies
• Provides medical and development leadership for cross-functional teams
• Serves on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
• Represents Vertex to outside medical personal in the development of clinical protocols and study conduct

Benefits

• Medical, dental and vision benefits
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• Educational assistance programs including student loan repayment
• Generous commuting subsidy
• Matching charitable donations
• 401(k) and so much more

What This Job Offers

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