Clinical Development Medical Director (Heme)

Role Summary

Clinical Development Medical Director (Heme) responsible for leading strategic and tactical activities across hematology clinical development, including trial strategy, data analysis, publications, 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
• Lead analysis of clinical trial data in context of internal/external needs, including publication strategy and 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 SME input for in-scope pipeline development activities (preclinical programs or external innovation/business development)
• Act as liaison between Clinical Development and other internal groups for hematology program working groups
• Represent Vertex/VCGT to external 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 is a plus
• 10 years of basic or clinical research experience in academia or industry, or equivalent with cross-functional teamwork
• Experience in analysis of research data and publications; working knowledge of biostatistics
• Working knowledge of GCP including medical monitoring; experience with design and execution of clinical trials
• Ability to travel up to 15% to support program activities

Skills

• Collaborative in fast-paced, matrixed environments; able to work independently when needed
• Creative problem-solving in clinical development
• Excellent verbal and written communication
• Desire to contribute to transformative work in serious diseases

Education

• MD, MD/PhD, DO or international equivalent