Clinical Development Associate Medical Director (Heme)

Vertex Pharmaceuticals is searching for an experienced Associate 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

Minimum Qualifications:

• 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
• 8  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