Executive Medical Director, Clinical Development, Hematology Cell Therapy

Regeneron Pharmaceuticals • Tarrytown, GA

7d • Hybrid

About The Position

The Executive Medical Director, Hematology, will provide overall clinical scientific leadership for the cell therapy 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 VP, Therapeutic Area Lead, Hematology. A typical day in the life may include the following: 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.

Requirements

• Advanced degree in medicine (MD or equivalent).
• Minimum of 6-8 years of industry experience in related therapeutic area clinical development.
• Demonstrated consistent track record in a range of leadership roles.
• Experience working with senior clinical development staff.
• Experience establishing credibility with external collaborators such as opinion leaders and regulators.
• Substantial experience in drug development (including experience with both IND and BLA/NDA submission).
• Experience in leading study start-up, directing and guiding study team execution, data cleaning, medical review, database locks, handling health authority responses.
• Strong commitment to impacting patients through drug development.
• Ability to work well within a team setting.

Nice To Haves

• MD/PhD strongly preferred.
• Specialized fellowship training in Hematology or Oncology is preferred.
• Cell therapy drug development experience is preferred.
• People management experience is a plus.

Responsibilities

• Provide overall clinical scientific leadership for the cell therapy program.
• Have responsibility for clinical development strategy and execution of clinical trials in the cell therapy area.
• Act as medical expert and leader in interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups).
• Act as medical expert and leader in interactions with internal collaborators (e.g., Research, Early Clinical Development, Global Medical Affairs, Marketing, HEOR).
• Act as medical expert and leader in interactions with internal decision boards.
• Develop unique and innovative clinical strategies to significantly shorten the development cycle.
• Design and develop smaller, yet robust and innovative FIH as well as Phase 2/3 programs.
• Lead dynamic and matrixed clinical teams in a fast-paced and hands-on environment.
• Lead and develop a team of MDs and clinical scientists to meet personal and business needs.

Benefits

• Health and wellness programs (including medical, dental, vision, life, and disability insurance)
• Fitness centers
• 401(k) company match
• Family support benefits
• Equity awards
• Annual bonuses
• Paid time off
• Paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree