Clinical Development Medical Director (Heme)

Role Summary

Medical Director to lead strategic and tactical activities for hematology clinical development, working with cross-functional teams on clinical development strategy, trial data analysis and publications, data generation activities, ongoing trial execution, and global regulatory submissions. May participate in pipeline development in the Hemoglobinopathies program 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 the context of strategic internal and external needs, including publication strategy and external communications
• Lead data generation activities such as real-world evidence studies, post-approval studies, and health outcome studies
• Provide subject matter expertise for global regulatory activities and documents including post-approval information requests, labeling, and data submissions
• Provide input for 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 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; experience in hematology/oncology including hematopoietic stem cell transplant is a plus
• 10 years of basic or clinical research experience in academic or industry settings or equivalent combination
• Experience in analysis of research data and publications with 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

• Ability to work collaboratively in a fast-paced, matrixed environment and to function independently
• Creative ability to independently resolve clinical development problems
• Strong verbal and written communication skills
• Commitment to innovative work in transforming outcomes for people with serious diseases

Education

• MD, MD/PhD, DO or international equivalent
• Biostatistics knowledge; clinical research methods; GCP familiarity

Additional Requirements

• Travel up to 15% to support program activities