Our client is a clinical-stage biotech company focused on developing cell therapies for ocular conditions. They have asked us to assist them in their search for a Chief Medical Officer.

Major tasks and responsibilities include:

• Oversees the clinical development strategy and processes within the company to ensure efficient, high-quality therapeutic development programs based on the highest scientific, medical, and regulatory standards.
• Leads the company’s efforts across clinical development, clinical operations, medical affairs, drug safety, regulatory affairs, and quality assurance. Builds and retains talent to support these functions to ensure current and future health of the organization.
• Plays a key in advancing corporate vision/strategy and executing mission critical goals in collaboration with CEO and the Board of Directors. Executes on these objectives in a highly cohesive manner.
• Provides strategic and operational guidance on corporate R&D playbook.
• Leads clinical development programs from late preclinical stage through registration and completion of post-approval commitments.
• Drives the development of clinical development plans, clinical concept sheets and protocols, confidential information brochures, data analysis plans, clinical study reports, and clinical sections of regulatory submissions.
• Monitors safety of clinical trials.
• Maintains an understanding of competitors and clinical development in relevant gene or cell therapy and ophthalmology by attending scientific meetings and tracking literature and marketing materials.
• Serves as the company’s spokesperson for all clinical and medical matters for diverse audiences such as shareholders, corporate partners, Board of Directors, and other key stakeholders.
• Represents the company with regulatory agencies and leads all clinical related communication with FDA and global regulatory bodies.
• Identifies and interacts with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans.
• Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
• Participates in leadership activities to enhance company culture.
• Cultivate relationships with SAB and expand clinical advisory board.

We seek candidates with the following qualifications:

• An MD or equivalent is required.
• Must have extensive clinical development experience in the biotech or pharma industry with a proven track record filing and winning approval for novel therapies.
• Must have significant experience in ophthalmology.
• Experience with cell and gene-based therapies is preferred.
• Requires the ability to lead and develop an overall clinical development strategy.
• Must have a solid track record and a natural ability of building diverse teams and bringing them together in a collaborative environment to achieve a common goal.
• Prior experience collaborating and interfacing with internal and external stakeholders and other diverse audiences, such as Boards and investors, within a cross-functional matrix environment is highly preferred.
• Requires a passion for building positive and productive organizational culture and must be committed to engendering credibility and confidence within and outside the company.
• The ability to work across multiple disciplines and prior experience working in a small-company environment is preferred.
• Requires knowledge of medical monitoring of clinical trials, including, but not limited to, responding to questions about patient eligibility, review of safety parameters, and receiving and processing SAEs.
• Must have a comprehensive understanding of clinical regulatory requirements and knowledge of all relevant guidelines.
• Must have a strong scientific background with a track record of defining and delivering on an innovative R&D strategy that has yielded critical drug development milestones.
• Must have strategic awareness in clinical development to prioritize product development to achieve business goals.
• An understanding of statistics and data management considerations for clinical trial design and scientific communications is required.
• Must have a patient-centric mindset.
• Must be a professional who demonstrates the highest level of integrity.
• Must be comfortable in a small organization where all leaders take a hands-on approach in a rapidly changing environment.

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 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.