Clinical Development Medical Director, Autoimmune/Rare Diseases

Job Description

General Summary:

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 and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development, and may also participate in other selected projects in clinical development.

Key Duties and Responsibilities:

• Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance
• Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution
• Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical sections of INDs and CTAs, safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
• Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR). Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Operations) for assigned studies
• Represents Vertex to outside medical personal in the development of clinical protocols and study conduct
• Performs other duties as assigned related to clinical programs

Knowledge and Skills:

• Excellent oral and written communication skills
• Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriate
• Effective at building alliances across functions, based on end-to-end drug development thinking and experience
• Experience developing and validating clinical endpoints and biomarkers in complex, heterogeneous disease populations
• Clinical Development experience in autoimmune/rare diseases, ideally in neurology, rheumatology, or hematology

Education and Experience:

• 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
• Typically requires 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
• Typically requires experience with design, execution, and analysis of clinical trials required
• International travel to be expected at 20%

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid  

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 [email protected]