Company Summary: The Foundation Fighting Blindness Inc. Clinical Research Institute (FFB CRI) is committed to developing treatments and cures of rare genetic diseases of the retina, including retinitis pigmentosa, macular degeneration, Usher syndrome, Stargardt disease and related conditions. These diseases, which affect more than 10 million Americans and millions more throughout the world, often lead to severe vision loss or complete blindness. Working with preeminent scientists, the FFB has funded breakthroughs in gene therapy, stem cells and bionic retinas, providing a historic opportunity for a promising new era in human clinical trials. We are the largest non-governmental source of research funds for inherited retinal degenerative diseases.
The FFB CRI works to accelerate the translation of laboratory-based research into clinical trials for treatments and cures of these degenerative diseases. As the translational arm of the Foundation Fighting Blindness, it is the bridge between scientific, clinical, governmental, pharmaceutical and financial communities to advance clinical trials of new treatments. The FFB CRI invests funds to support Phase 1 and Phase 2 clinical trials to expedite the commercialization of treatments for the entire spectrum of inherited retinal diseases, and also provides assistance for the management of clinical trials and subsequent commercialization.
Thanks to research advances made possible by FFB and research-funding organizations around the world, more clinical trials for therapies of inherited retinal diseases are underway than ever before (currently 24 in Phase 1/2; 1 in Phase 3). While not all will gain regulatory approval, the momentum in clinical development provides real promise for saving and restoring vision of those affected.
Position Summary: 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.
Primary Responsibilities The successful candidate will perform the following:
Develop and lead the overall clinical vision for the organization
Direct the development of clinical strategies and plans to integrate pharmaceutical compounds and other therapeutic regimens into the standard practice of ophthalmology
Orchestrate and manage clinical aspects of regulatory strategies; oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
Ensure clinical development programs meet quality and safety standards required by medical and regulatory agencies, providing leadership in medical affairs, drug safety activities, etc.
Provide clinical support and work with other members of the management team to develop and communicate and help to implement the overall corporate strategy
Develop regulatory strategies for approval of new treatments for IRDs, including use of novel endpoints
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
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
Have P&L and budgetary responsibility for clinical development and regulatory activities, providing strategic input to the annual and long-range budgetary processes
Assist with due diligence of business development opportunities
Collaborate with corporate and nonprofit associates and partners
Qualification Requirements 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)