Senior Medical Director, Clinical Development, Ophthalmology

About the role

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.

Responsibilities

• 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.
• Safeguards 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.

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); however, a candidate with a strong academic background and less experience may be considered.
• 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.
• Strong 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.

Qualifications

• 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); however, a candidate with a strong academic background and less experience may be considered.
• 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.
• Strong 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.

Skills

• Strong consensus-building skills.
• Collaboration with multi-disciplinary teams.
• Leadership in interactions with external stakeholders.
• Development of clinical strategies.
• Design and development of clinical programs.
• Ensuring safety and quality of clinical documents.
• Preparing regulatory submission documents.

Benefits

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits (e.g. medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

Pay

$333,300.00 - $450,900.00 annually

Schedule

4 days a week on-site in Tarrytown, NY, Cambridge, MA, or Warren, NJ