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Job Description

The Sr. Medical Director, Clinical Development, will serve as the Medical Lead for Vertex clinical trials for an assigned program, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. This individual will work on multiple trials from pre-clinical stage through 3 and may also participate in selected projects in the clinical development programs.

Key Duties and 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

Knowledge and Skills:

• 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

• Board certification/eligibility in a specialty is highly desired

Education and Experience:

• MD, DO or equivalent ex-US medical degree

• Board certification/eligibility in Hematology, Neurology, or Nephrology is highly desired

• Expertise in the following Translational Medicine or Cell & Gene Therapy highly desired

• Typically requires 7 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experience

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