Chief Medical Officer

We are currently seeking a Chief Medical Officer (CMO) who will be responsible for all clinical development activities, including human proof of concept through product approval, in order to meet key milestones and bring products to market in compliance with global regulatory, legislative, and medical/health requirements.

The Chief Medical Officer will report directly to the Chief Executive Officer. The primary role of the CMO will be to provide leadership and direction for FFB’s pipeline of clinical development programs. The CMO will be responsible for the strategy, direction and execution of the company’s clinical development plans.

The successful candidate will perform the following:   

1.Develop and lead the overall clinical vision for the organization

2.Direct the development of clinical strategies and plans to integrate pharmaceutical compounds and other therapeutic regimens into the standard practice of ophthalmology

3.Orchestrate and manage clinical aspects of regulatory strategies; oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results

4.Ensure clinical development programs meet quality and safety standards required by medical and regulatory agencies, providing leadership in medical affairs, drug safety activities, etc.

5.Provide clinical support and work with other members of the management team to develop and communicate and help to implement the overall corporate strategy

6.Develop regulatory strategies for approval of new treatments for IRDs, including use of novel endpoints

7.Will act as a spokesperson for the Institute with key opinion leaders at scientific conferences and advisory boards, building and maintaining relationships consistent with investigative, developmental, and commercial objectives

8.Represent the Institute and its programs to external audiences, including the investment, medical, and regulatory communities, as well as pharmaceutical and biotechnology industry collaborators/partners

9.Have P&L and budgetary responsibility for clinical development and regulatory activities, providing strategic input to the annual and long-range budgetary processes

10.Assist with due diligence of business development opportunities

11.Collaborate with corporate and nonprofit associates and partners

The ideal candidate will offer:

• Advanced degree (MD, PhD, PharmD) in a relevant scientific discipline; MD with Board Certification in ophthalmology preferred
• 15 Years minimum experience in clinical ophthalmology, with experience in retinal therapeutics preferred
• Pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs
• Multiple years of management experience leading a clinical and/or an investigative group, including clinical/medical affairs and clinical operations
• A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND and NDA filings
• Knowledge of relevant FDA regulations and guidelines; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities is a plus
• Experience with, or strong knowledge of ophthalmology drug development
• Experience or knowledge of orphan or genetic rare disease drug development is also a plus
• Must have a thorough knowledge of clinical research concepts and practices, including clinical trials
• Experience in translational medicine, clinical pharmacology, and early stage development is desirable
• Effective leadership, project management, and budget management experience required
• Must read, write, and speak fluent English, possess excellent communication skills, and will be capable of articulating the Institute’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, and the ophthalmology and investor communities
• Must have outstanding executive presence
• Must have the highest personal values and ethical standards
• An ability to be productive and successful in a fast paced, hands-on work environment is critical
• Outstanding ability to communicate wisely, thoroughly, and frequently with the CRI Board of Directors; including preparation of the agendas and minutes of regular meetings of the CRI Board of Directors
• Willingness and ability to travel, including international, is required (anticipated this will be 25-30 % of work time)