Job Description
The Senior Medical Director (SMD) will contribute to the development of the Clinical Strategy, own Clinical Development Plans, and work closely with cross-functional multidisciplinary teams on clinical trial design and execution for the Pain clinical development program. The SMD may also serve as the Medical Lead for Clinical Trials that will be conducted for a given asset.
Key Duties and Responsibilities:
- Contributes to 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
- 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, , including weekly safety updates
- 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
Travel up to 30% depending on business needs
Knowledge and Skills:
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Global clinical research experience, and experience interacting with regulatory authorities is highly desired
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Ability to work collaboratively in a fast-paced, team-based matrix environment
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Ability to work independently to resolve challenges
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Enterprise-wide thinking and ability to work in ambiguity
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Ability to ensure the completeness of team work
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Excellent oral and written communication skills
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Board certification/eligibility in a specialty is highly desired
Education and Experience:
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MD, DO or equivalent ex-US medical degree
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Board certification/eligibility in a specialty is highly desired
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Typically requires 7-10 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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Supervisory experience required
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.