Job Summary The Senior Medical Director will define the clinical development strategy of an asset, 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. Key Responsibilities Defines a clinical development strategy and prepares 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 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 sections 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 personnel in the development of clinical protocols and study conduct. Knowledge and Skills Global clinical research experience and experience interacting with regulatory authorities. 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‑U.S. medical degree. Board certification/eligibility in a specialty is highly desired. Typically requires 12 years in the pharmaceutical/biotech industry, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experience. Work Arrangement Hybrid‑Eligible or On‑Site Eligible. Hybrid: work remotely up to two days per week; On‑Site: work five days per week on‑site with ad hoc flexibility. Pay Range $280,600 - $420,800. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Equal Employment Opportunity 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 or to perform the essential functions of the position should request an accommodation from the recruiter or hiring manager. #J-18808-Ljbffr
Clinical Development Senior Medical Director-Neurology
VERTEX PHARMACEUTICALS INC (US)
boston, boston
Published 4 days ago
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