Our client is a late-stage biopharmaceutical company focused on developing therapies for currently untreatable eye diseases. 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 clinical development programs from late preclinical stage through registration and completion of post-approval commitments.
• Leads company’s efforts across clinical development, clinical operations, medical affairs, drug safety, and possibly 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 role in advancing corporate vision/strategy and executing on 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.
• 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 (IND, CTA, and CTD).
• Along with commercial team, co-leads the pre-launch strategy for the late development pipeline.
• Ensures safety of clinical trials.
• Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
• Maintains a deep understanding of the competitive landscape in relevant ophthalmology and rare disease areas by attending scientific meetings and tracking literature and marketing materials.
• Serves as a company’s spokesperson for clinical and medical matters for diverse audiences such as shareholders, corporate partners, Board of Directors, investors, and other key stakeholders.
• Represents the company in clinical-related communications 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.
• Forms and cultivates relationships with SAB and clinical advisory board.
• Participates in leadership activities to enhance company culture.

We seek candidates with the following qualifications:

• A Medical degree or equivalent is required.
• Must have significant experience in Ophthalmology or in Rare Disease drug development.
• Must have a proven track record leading regulatory interactions with the FDA, including preparation of NDA/BLA filing and gaining approval for novel therapies. Experience dealing with ex-US regulatory agencies a plus.
• Must have experience collaborating with internal and external stakeholders, such as boards, investors, payers, key opinion leaders.
• Must have contributed to the successful commercial launch of an ophthalmic or a rare disease therapeutic.
• Must have a solid track record of building and leading diverse teams and bringing teams together in a collaborative environment to achieve a common goal.
• The ability to work across multiple disciplines and prior experience working in a small-company environment are preferred.
• Requires a passion for building positive and productive organizational culture and a commitment to engendering credibility and confidence within and outside the company.
• 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.
• Must have extensive clinical development and strategy experience in the biotech or pharma industry.
• Must have a comprehensive understanding of clinical regulatory requirements and all relevant guidelines, including post approval compliance.
• Requires knowledge of medical monitoring of clinical trials, including, but not limited to, patient eligibility, review of safety parameters, and receipt, review, and processing of SAEs.
• Must have strategic awareness to manage product development to achieve business goals.
• Must have an understanding of statistics and data management considerations for clinical trial design and scientific communications.
• A patient-centric mindset is required.
• 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 150 Best Executive Recruiting Firms.