Senior Medical Director, Clinical Development, Ophthalmology

Regeneron Pharmaceuticals • Tarrytown, GA

2d • Hybrid

About The Position

The Senior Medical Director will play a key role in clinical development programs within the Ophthalmology portfolio, including being accountable for deliverables of the assigned program(s), supporting resourcing, budget, and timelines of these programs. This role serves as scientific and medical lead for clinical team(s) working closely with operational leads. This role requires a high-performing and highly passionate individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research. The incumbent will collaborate with multi-disciplinary clinical teams, assisting in guiding and executing clinical development strategies and subsequent regulatory submissions. This role is responsible for the design and execution of first-in-human through registration-enabling studies. This role will serve as a representative to a range of audiences, including Internal Medicine leadership, executive leadership, development partners, and US and global regulatory agencies. The Senior Medical Director, Ophthalmology reports to the Vice President, Ophthalmology Therapeutic Area Lead. A typical day in the life of a Senior Medical Director, Clinical Development may include the following: Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Global Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards. Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs and develops more efficient and innovative, yet robust Phase 1, 2, and 3 programs. Works closely with the research and discovery teams to provide input on the next generation of targets in the field. Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety. Ensures quality of all clinical documents (e.g., investigators’ brochure, protocol, study report, clinical components of regulatory submissions, safety related documents). Develops written responses to regulatory agency questions and prepares regulatory submission documents. Has strong consensus-building skills and the ability to collaborate with multi-disciplinary teams towards sound decision-making. Key member of dynamic and matrixed clinical teams in a fast-paced and hands-on environment.

Requirements

• A M.D. or D.O. or equivalent medical degree and relevant training
• A trained Ophthalmologist (board certified or eligible or equivalent) is essential
• A minimum of 4 years of industry experience (early or late clinical development)
• Experience in leading proof of concept and/or registrational clinical trials, including protocol design, managing study start-up, directing, and guiding study team execution, data cleaning, medical monitoring/review, database locks
• Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidate products is required
• A strong commitment to clinical research and the ability to work well within a team setting are essential

Nice To Haves

• A candidate with a strong academic background and less than 4 years of industry experience may be considered

Responsibilities

• Accountable for deliverables of the assigned program(s)
• Supporting resourcing, budget, and timelines of these programs
• Serves as scientific and medical lead for clinical team(s) working closely with operational leads
• Serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research
• Collaborate with multi-disciplinary clinical teams, assisting in guiding and executing clinical development strategies and subsequent regulatory submissions
• Responsible for the design and execution of first-in-human through registration-enabling studies
• Serve as a representative to a range of audiences, including Internal Medicine leadership, executive leadership, development partners, and US and global regulatory agencies
• Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Global Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards
• Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape
• Designs and develops more efficient and innovative, yet robust Phase 1, 2, and 3 programs
• Works closely with the research and discovery teams to provide input on the next generation of targets in the field
• Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety
• Ensures quality of all clinical documents (e.g., investigators’ brochure, protocol, study report, clinical components of regulatory submissions, safety related documents)
• Develops written responses to regulatory agency questions and prepares regulatory submission documents
• Has strong consensus-building skills and the ability to collaborate with multi-disciplinary teams towards sound decision-making
• Key member of dynamic and matrixed clinical teams in a fast-paced and hands-on environment

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: Senior
• Education Level: Ph.D. or professional degree