Clinical Development Medical Director (Heme)

Role Summary

Clinical Development Medical Director (Heme) leads strategic and tactical activities for a broad range of ongoing clinical development activities within the Hematology clinical development team. Works with multidisciplinary teams on clinical development strategy, trial data analysis and publications, data generation activities, trial execution, and regulatory submissions. May participate in Hemoglobinopathies pipeline development depending on background and interest.

Responsibilities

• Serve as a clinical development lead for hematology clinical development strategy and overall clinical development plans
• Facilitate analysis of clinical trial data in context of strategic internal and external needs, including publication strategy and execution and related external communications
• Lead additional data generation activities such as real-world evidence studies, post-approval studies, and health outcomes studies
• Provide SME input for global regulatory activities and documents including post-approval information requests, labeling, and data submissions
• Provide input for in-scope pipeline development activities (e.g., 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 activities, including supporting medical monitors, advisory boards, and data presentations

Qualifications

• MD, MD/PhD, DO or international equivalent
• Board certification/eligibility in internal or pediatric medicine or another relevant medical field is highly desired; experience in hematology/oncology including stem cell transplant medicine is a plus
• 10 years of basic or clinical research experience in academic or industry settings, or equivalent combination including cross-functional teamwork
• Experience in analysis of research data and publications with working knowledge of biostatistics
• Working knowledge of GCP including medical monitoring; experience with clinical trial design and execution
• Ability to travel up to 15% to support program activities

Skills

• Collaborative, fast-paced, team-based, matrixed environment
• Creative problem-solving for clinical development
• Excellent verbal and written communication

Education

• MD, MD/PhD, DO or international equivalent