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Job Description

Vertex Cell & Gene Therapy (VCGT) is searching for an experienced Executive 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, and involvement in in-scope external innovation/business development activities. This is an excellent opportunity for a motivated drug developer to shape the Hematology pipeline at VCGT and lead innovative clinical stage cell and gene therapy programs. The Executive Medical Director will provide clinical development leadership for cross-functional teams to support late phase clinical development activities including global regulatory filing for approval, support clinical study execution in a matrixed team environment, and shape the clinical development strategy for hemoglobinopathies.

Key Responsibilities

· Serve as the clinical development lead for activities related to global regulatory engagements for several programs in partnership with clinical development team members and other line functions, including the preparation of regulatory documents and submissions.

· Lead and provide clinical and strategic guidance to study related documents including clinical study reports, BLA/MAA and other regulatory filing documents, study protocols and amendments, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other clinical development team members and line functions

· Provide clinical development leadership for cross-functional teams related to ongoing clinical stage programs in sickle cell disease and beta-thalassemia

· Provide leadership and input to pipeline development strategy, including preclinical programs and external innovation/business development

· 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,

· Support cross-function study teams for ongoing clinical trials including working with other team members to achieve efficient, high-quality study execution, data analysis, and study outputs, and serving as a back-up Medical Monitor as needed

· Travel up to 30% depending on business needs

Qualifications:

· MD, MD/PhD, DO or the international equivalent

· Board certification in Hematology highly desired

· Minimum of 5 years of 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

· BLA/MAA 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

Company Information