Clinical Development Senior Medical Director, Hematology

Job Description

General Summary:

Vertex/VCGT (Cell and Gene Therapy) is searching for an experienced Senior Medical Director for a leadership role in managing assets in its hematology development portfolio, specifically including sickle cell disease and beta-thalassemia. The position includes leadership opportunities for cell and gene therapy preclinical and clinical stage assets, including those involving CRISPR/Cas9-based gene editing. This is an excellent opportunity for a motivated drug developer to shape the Hematology pipeline at VCGT and lead innovative pre-clinical and clinical stage cell and gene therapy programs. The Senior Medical Director will provide clinical development leadership for cross-functional teams to support early phase clinical development activities, facilitate achievement of clinical development goals in a matrixed team environment, and shape the clinical development strategy for hemoglobinopathies.

Key Duties and Responsibilities:

• Serve as the clinical development lead for cross-functional activities related to pre-clinical and early phase development of hematology pipeline programs, including the development of study protocols and other study related documents, pre-IND and IND submissions, and overall clinical development plans
• Provide clinical development leadership and input to overall hematology pipeline development strategy, including preclinical programs and external innovation/business development
• Provide clinical development leadership for cross-functional teams related to ongoing clinical stage programs in sickle cell disease and beta-thalassemia, including support for ongoing clinical trials and late phase development deliverables, such as protocol amendments, regulatory submissions, data interpretation, and publications planning
• Present and communicate program related activities to senior company leadership
• Represent Vertex/VCGT 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 is highly desired
• Clinical development and/or clinical/scientific experience in cell & gene therapy programs preferred but not required
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• Ability to work independently and creatively to resolve challenges
• Excellent verbal and written communication skills

Education and Experience:

• MD, MD/PhD, DO or the international equivalent
• 12+ years equivalent combination of education and experience, with minimum of 4 yearsof pharmaceutical/Biotech industry experience in clinical development, including experience managing clinical trial programs and clinical development plans
• Global clinical development experience including experience interacting with global regulatory authorities

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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