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About the Role

The Clinical Development Medical Director, Autoimmune/Rare Diseases will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution. This role is responsible for monitoring the safety of enrolled subjects on assigned trials and may participate in other selected projects in clinical development.

Responsibilities

• Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents with minimal guidance.
• Serves on cross-functional Study Execution Teams (SET) for assigned trials, ensuring efficient, high-quality study execution.
• Participates in the preparation of regulatory documents for submissions, including INDs, CTAs, safety reports, annual reports, and responses to regulatory authorities and Ethics Committees/IRBs.
• Provides scientific and clinical input to study-related documents and analysis plans, including ICF, CRF, SAP, CPAP, and CSR.
• Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex for assigned studies.
• Represents Vertex to outside medical personnel in the development of clinical protocols and study conduct.
• Performs other duties as assigned related to clinical programs.

Requirements

• MD, DO or equivalent ex-US medical degree.
• Clinical Development experience in autoimmune/rare diseases, ideally in neurology, rheumatology, or hematology.
• Extensive clinical research experience in an academic or industrial setting, or the equivalent combination of education and experience.
• Experience in analysis of research data and publications.
• Working knowledge of biostatistics.
• Working knowledge of GCP, scientific and clinical research methods and clinical study design.
• Experience with design, execution, and analysis of clinical trials.
• International travel expected at 20%.

Skills

• Excellent oral and written communication skills.
• Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently.
• Effective at building alliances across functions.
• Experience developing and validating clinical endpoints and biomarkers in complex, heterogeneous disease populations.

Location

• Hybrid-Eligible
• On-Site Eligible

Work Type

• Hybrid
• On-Site

Experience Level

• Clinical Development experience in autoimmune/rare diseases
• Extensive clinical research experience
• Experience in analysis of research data and publications
• Working knowledge of biostatistics
• Working knowledge of GCP, scientific and clinical research methods and clinical study design
• Experience with design, execution, and analysis of clinical trials

Education Level

• MD, DO or equivalent ex-US medical degree

About the Company

• Vertex is a global biotechnology company that invests in scientific innovation.

Equal 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 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