Clinical Development Associate Medical Director, Hematology

Job Description

General Summary: 

Vertex Pharmaceuticals is searching for an experienced Associate Medical Director to serve as the Medical Lead for ongoing clinical trials within the Hemoglobinopathy clinical development team. You will work as part of multidisciplinary cross-functional study teams on clinical trial strategy, design and execution, serving as the primary Medical Monitor responsible for monitoring the safety of subjects in multiple ongoing cell and gene therapy clinical trials in hemoglobinopathies. You will assist with the clinical development strategy, writing of study related materials, and act as a liaison between clinical development and other internal groups at Vertex and the VCGT. You may also participate in pipeline development activities in the Hemoglobinopathies program, depending on background and interest. 

Key Duties and Responsibilities: 

• Serve as the medical monitor for the assigned cell and gene therapy clinical trials in hemoglobinopathies 

• Serve on cross-functional Study Execution Teams (SETs) 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 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 at Vertex/VCGT for assigned studies 

• Represent Vertex/VCGT to outside medical personnel in the development of clinical protocols and study conduct 

• Travel to investigator meetings and to study sites to build relationships with investigators and site staff, provide trainings and help facilitate other protocol and study related activities   

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