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 m inimum of 4 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
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