Vertex is searching for an experienced Associate Medical Director to serve as the Medical Lead for clinical trials within the Hemoglobinopathy clinical development team. This role will include working with cross-functional teams on clinical trial strategy, design, and execution. She/he will serve as a primary and back-up medical monitor responsible for monitoring the safety of subjects in ongoing cell and gene therapy clinical trials in hemoglobinopathies. She/he will assist with the overall clinical development strategy, the writing of study related materials, and act as a liaison between clinical development and other internal groups at Vertex and the VCGT. This individual may also participate in pipeline development activities in the Hemoglobinopathies program, depending on background and interest.
- Serve as the medical monitor for the assigned cell and gene therapy clinical trials in hemoglobinopathies, assessing issues related to protocol conduct and subject safety.
- Serve on cross-functional study teams for the assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
- Participate and provide clinical and scientific subject matter expertise for the development of study related documents including study protocols, statistical analysis plans, informed consent forms (ICF), clinical research forms (CRF), investigator's brochures (IB), clinical study reports (CSR), and other key study-related documents in conjunction with other clinical development team members
- Participate and provide input in the preparation of regulatory documents in support of global regulatory submissions, including safety reports, responses to regulatory authorities and ethics committees/IRBs, clinical study reports, and other documents as appropriate
- Assist in the publications and communications processes for external release of study related data.
- Provide subject matter expertise and input to pipeline development activities, including preclinical programs and external innovation/business development
- Act as liaison between clinical development and other internal groups at Vertex/VCGT for assigned studies
- Represent Vertex/VCGT to outside medical personnel in the development of clinical protocols and study conduct
- MD, MD/PhD, DO or the international equivalent
- Minimum of 2 years of basic or clinical research experience in an academic or industrial setting designing and executing clinical trials
- Working knowledge of GCP including medical monitoring; experience with scientific/clinical research methods and clinical study design