Senior Medical Lead
Boost your chances before you apply.
International Recruiting LLC
US
Summary
The Senior Medical Lead will direct Zenitar's US clinical organization and oversee global clinical development strategy for hematology/oncology programs. This role involves managing FDA interactions, leading clinical teams, and ensuring high-quality trial execution and medical governance.
Job Description
The Senior Medical Lead will lead Zenitar’s US clinical organization and serve as the senior medical and clinical development leader for the company’s global programs. The role is responsible for US and global clinical development strategy, PI/KOL engagement, FDA interactions, medical governance, clinical execution oversight, and overall trial quality.
Key Responsibilities
• Lead the clinical development strategy and execution of Zenitar’s US and global hematology/oncology programs.
• Serve as the senior medical representative in FDA and other health authority interactions.
• Build and maintain relationships with leading investigators and KOLs.
• Provide medical and strategic oversight of clinical trials, including protocol development, benefit-risk assessment, safety governance, and data interpretation.
• Lead and oversee the US clinical team, CROs, medical monitors, and other external partners.
• Support regulatory submissions, including IND amendments, End-of-Phase meetings, NDA/BLA preparation, and responses to health authority questions.
• Provide clinical input to corporate strategy, business development, board discussions, and investor communications.
• Establish appropriate clinical governance, quality standards, and decision-making processes within a fast-paced biotech environment.
Key Qualifications
• MD or equivalent medical degree; board certification or advanced training in hematology/oncology is strongly preferred.
• 12+ years of innovative drug clinical development experience, including at least 5 years in hematology/oncology.
• Demonstrated leadership experience in sponsor-side Phase 2 and/or Phase 3 clinical development.
• Prior experience leading a myelofibrosis or broader MPN program, ideally involving a JAK inhibitor, is highly preferred.
• Proven experience leading FDA interactions and cross-functional global development teams.
• NDA/BLA or other late-stage regulatory submission experience is strongly preferred.
• Established relationships with leading US MF/MPN investigators would be a significant advantage.
• Ability to operate both strategically and hands-on in a small, growth-stage biotechnology company.
