Clinical Development Medical Director (Heme)

Job Description

General Summary:

Vertex Pharmaceuticals is searching for an experienced Medical Director to lead strategic and tactical activities for a broad range of ongoing clinical development activities within the Hematology clinical development team. You will work as part of multidisciplinary cross-functional teams on clinical development strategy, clinical trial data analysis and publications, clinical development related data generation activities, ongoing clinical trial execution, and contribute to global regulatory submissions. You may also participate in pipeline development activities in the Hemoglobinopathies program, depending on background and interest.

Key Duties and Responsibilities:

• Serve as a clinical development lead for hematology clinical development strategy and overall clinical development plans
• Serve as the clinical development lead to facilitate analysis of clinical trial data in context of strategic internal and external needs, including publication strategy and publication plan execution as well as associated external communications activities
• Serve as the clinical development lead for additional data generation activities such as those related to read world evidence studies, post- approval studies, and health related outcomes studies
• Contribute clinical and scientific subject matter expertise for global regulatory activities and documents including post- approval information requests and reports, labeling, and data submissions such as study reports and summary documents.
• Provide subject matter expertise and input for in scope pipeline development activities, such as preclinical programs or external innovation/business development
• Act as liaison between Clinical Development and other internal groups for hematology program related working groups
• Represent Vertex/VCGT to outside medical personnel for clinical development related activities, including supporting medical monitors of ongoing clinical trials, advisory boards, and data presentations.

Knowledge and Skills:

• Ability to work collaboratively in a fast-paced, team-based, matrixed environment and to function independently, as appropriate
• Utilize novel and creative methods to independently resolve clinical development problems
• Working knowledge of GCP, biostatistics, data management, clinical operations and clinical pharmacokinetics to support trial design and execution
• Experience in analysis of research data and publications
• Excellent verbal and written communication skills
• A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society

Education and Experience:

• MD, MD/PhD, DO or the international equivalent
• Board certification/eligibility in internal or pediatric medicine or another relevant medical field is highly desired; clinical development/experience in hematology and/or oncology, including hematopoietic stem cell transplant medicine, is a plus
• 10 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience including working on cross-functional teams.
• Experience in analysis of research data and publications including a working knowledge of biostatistics.
• Working knowledge of GCP including medical monitoring; experience with scientific/clinical research methods and with the design and execution of clinical trials.
• Ability to travel (up to 15%) to support program activities as needed

Pay Range:

Disclosure Statement:

Flex Designation:

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.

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