Our client is a pharmaceutical company focused on addressing unmet medical needs in retinal health through ophthalmic innovation. They have asked us to assist them in their search for a Vice President Clinical Development.

Major tasks and responsibilities include:

• Report directly to the Chief Medical Officer.
• Provide strategic leadership for clinical development across one or more assets. Direct reports may include one or more physicians and clinical scientists.
• Participate in clinical leadership team meetings and provide medical and scientific expertise on the strategy, design, execution and interpretation of data from early to late-stage clinical development programs.
• Collaborate cross-functionally to author and review clinical and regulatory documents, including protocols, ICFs, CRFs, CSRs, IBs, DSURs, PSURs, regulatory packages, NDAs, MAAs.
• Review and interpret clinical trial data.
• Secure, analyze, and report on competitive intelligence related to successful conduct and execution of studies sponsored by other organizations and new data that may impact programs.
• Provide mentorship and development opportunities to others within the company.
• Responsible for resourcing clinical development programs within the functional area.
• Oversee medical monitoring of one or more clinical trials.
• Ensure that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.
• Represent clinical development to executive leadership, KOLs, investigators, regulatory agencies.
• Present findings internally and externally (e.g., investigator meetings, regulatory agency meetings) acting as a spokesperson for the company.
• Work cross-functionally with clinical operations, biometrics and data management, drug safety, drug formulation development, regulatory, pre-clinical and clinical pharmacology and medical affairs.
• Evaluate scientific information and new ideas to assist in identifying new research opportunities.
• Successfully interface with development partners.
• Contribute to determining global strategy for development of clinical development assets.
• Prepare manuscripts, abstracts and presentations for scientific meetings.

We seek candidates with the following qualifications:

• Medical degree or equivalent with specialized training in ophthalmology required.
• Must have a minimum of 10 years of experience in ophthalmology clinical development across both small and large pharmaceutical organizations.
• Proven expertise in representing clinical development during regulatory interactions, including successful NDA/MAA submissions.
• Extensive global clinical trial experience, with a minimum of three clinical studies.
• Demonstrated ability to supervise and mentor physicians and clinical scientists, including co-authoring study protocols and regulatory documents.
• In-depth knowledge of ophthalmology clinical drug development, including FDA regulations, statistics, and safety.
• Experience working with small molecule targeted therapies; familiarity with VEGF inhibitors or other anti-angiogenic agents is highly desirable.
• Exceptional written and verbal communication skills.
• Willingness and ability to travel as required.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.