Executive Medical Director, Clinical Development, (Thrombosis)

Role Summary

The Executive Medical Director, Hematology will provide overall clinical scientific leadership for the Factor XI program and have responsibility for our clinical development strategy and execution of clinical trials in this area. This role will be a key partner with the Global Program Head to design the optimal development strategy for this portfolio. This role requires an impactful and highly hard-working individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to hematology clinical research. The Executive Medical Director, Hematology reports directly to the SVP, Hematology.

Responsibilities

• Acts as medical expert and leader in interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal collaborators (e.g., Research, Early Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards.
• Uses excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions. Uses that creativity and knowledge to easily build and defend data driven plans and decisions, both with internal scientific management and the Company’s partners / collaborators.
• Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs and develops smaller, yet robust and innovative FIH as well as Phase 2/3 programs.
• Drives for strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making. Leads dynamic and matrixed clinical teams in a fast-paced and hands-on environment.
• Leads and develops a team of MDs and clinical scientists to meet personal and business needs.

Qualifications

• Required: Demonstrated consistent track record in a range of leadership roles that include working with senior clinical development staff, establishing credibility with external collaborators such as opinion leaders and regulators, and demonstrating substantial experience in drug development (including experience with both IND and BLA/NDA submission).
• Required: Experience in leading study start-up, directing and guiding study team execution, data cleaning, medical review, database locks, handling health authority responses.
• Required: A strong commitment to impacting patients through drug development and the ability to work well within a team setting.
• Education: Advanced degree in medicine (MD or equivalent); MD/PhD strongly preferred.
• Experience: Minimum of 6-8 years of industry experience in related therapeutic area clinical development, including experience with parenterally administered small molecules and biopharmaceuticals. Total of 12 years of clinical development experience with 6-8 years in industry and remainder in academic settings is expected. At least 5 years of people management experience (may include matrix management).
• Location: On-site required, minimum of 4 days per week in Tarrytown, NY or Basking Ridge, NJ.

Education

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

Additional Requirements

• On-site presence requirement: minimum 4 days per week at specified U.S. locations.