Executive Medical Director, Clinical Development, (Thrombosis)

Role Summary

Executive Medical Director, Clinical Development, (Thrombosis) – provides clinical scientific leadership for the Factor XI program, develops and executes the clinical development strategy and trials, partners with Global Program Head to design development plans, and serves as a clinical role model for the team.

Responsibilities

• Acts as medical expert and leader in interactions with external collaborators (regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal collaborators (Research, Early Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards.
• Uses scientific standing to address issues with rigor and creative solutions; build and defend data-driven plans and decisions with internal management and partners.
• Develops innovative clinical strategies to shorten development cycles; designs and develops smaller, robust FIH as well as Phase 2/3 programs.
• Drives consensus-building and leads multi-disciplinary teams toward sound decision-making; leads dynamic, matrixed clinical teams in a fast-paced, hands-on environment.
• Leads and develops a team of MDs and clinical scientists to meet personal and business needs.

Qualifications

• Demonstrated track record in leadership roles with external collaborators and substantial experience in drug development (including IND and BLA/NDA submissions).
• Experience in leading study start-up, guiding study team execution, data cleaning, medical review, database locks, and handling health authority responses.
• Strong commitment to impacting patients through drug development and ability to work well within a team.

Skills

• Clinical development leadership
• Strategic planning and program design
• Cross-functional collaboration
• Regulatory affairs and interactions with authorities
• Data interpretation and scientific communication

Education

• Advanced degree in medicine (MD or equivalent); MD/PhD strongly preferred.

Additional Requirements

• Minimum 6-8 years of industry experience in related therapeutic area clinical development, including parenterally administered small molecules and biopharmaceuticals.
• Total of ~12 years of clinical development experience, with at least 6-8 years in industry; remaining experience in academic setting.
• At least 5 years of people management experience, including matrix environments.
• On-site requirement: minimum of 4 days weekly in Tarrytown, NY or Basking Ridge, NJ.