Clinical Development Associate Medical Director – Hematology

Clinical Development Associate Medical Director – Hematology

Requirements

• 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, working on cross-functional teams with experience involving clinical trial design and execution, data analysis and scientific publication development
• Working knowledge of GCP including medical monitoring; experience with scientific/clinical research methods and clinical study design
• Ability to travel (up to 15%) to support program activities as needed

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

Preferred Qualifications

• 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