Clinical Development Senior Medical Director, Inflammation

Job Description

General Summary:

Vertex is seeking an experienced Senior Medical Director for a leadership role in Inflammation Clinical Development. The individual will work with cross- functional multidisciplinary teams to define overall disease strategy as well as clinical trials strategy, design, and execution, and will serve as the Medical Lead for clinical trials that will be conducted in this therapeutic area. The Senior Director will also engage in analysis, presentation and publications of relevant data.

Key Duties and Responsibilities:

• Serve as the clinical development lead for cross functional activities related to pre-clinical and early through late phase development including development of study protocols and other study related documents, pre-IND and IND submissions and overall clinical development plans
• Participate in the development of statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions
• Lead the Clinical Development Team, and work cross functionally to define a project strategy and ensure execution against approved Disease strategy including a Phase 2 study
• Participate 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
• Interface with regulatory authorities as appropriate
• Represent Vertex to external stakeholders including investigators, key opinion leaders, governmental/policy groups, and community/patient advocacy groups as needed for achievement of program goals

Knowledge and Skills:

• IND filing experience
• Clinical Development and or clinical/scientific expertise in inflammation clinical development is highly desired
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• Ability to work independently and creatively to resolve challenges
• Excellent oral and written communication skills
• Ability to travel up to 25%, domestic and international is desired

Education and Experience:

• MD, DO or equivalent ex-US medical degree
• Board certification/eligibility in a specialty is highly desired
• 12 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experience
• Board certification/eligibility in Rheumatology with experience in inflammation clinical development

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Flex Designation:

Flex Eligibility Status:

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