Clinical Development Medical Director (Heme)

Role Summary

Clinical Development Medical Director (Heme) role focusing on leading strategic and tactical activities for hematology clinical development, including trial data analysis, publications, data generation, and global regulatory submissions. Potential involvement in hematoglobinopathies pipeline development based 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 external communications
• Lead additional data generation activities such as real-world evidence studies, post-approval studies, and health outcomes studies
• Provide subject matter expertise for global regulatory activities and documents (post-approval information requests, labeling, study reports, and summaries)
• Provide 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 outside medical personnel for clinical development activities, including supporting medical monitors, advisory boards, and data presentations

Qualifications

• Required: MD/DO or international equivalent; 10 years of basic or clinical research experience; working knowledge of GCP and biostatistics; ability to travel up to 15%
• Preferred: Board certification/eligibility in internal or pediatric medicine or relevant field; hematology/oncology experience including hematopoietic stem cell transplant; experience in regulatory submissions and clinical trial design
• Experience in analysis of research data and publications; excellent verbal and written communication

Skills

• Collaborative, fast-paced, matrixed environment work style
• Creative problem-solving in clinical development
• Strong communication and cross-functional collaboration

Education

• MD, MD/PhD, DO or international equivalent