Our client is a biotechnology company advancing treatments for T cell-driven autoimmune diseases. They have retained us to assist in their search for a Chief Medical Officer, Immunology.

Major tasks and responsibilities include:

• Report directly to the Chief Executive Officer.
• Recruit, build and nurture a strong team capable of meeting development milestones within agreed upon timelines and budgets.
• Play a key role in advancing the strategic and operational guidance for the corporate R&D playbook. Work with other members of the executive team to develop and execute the company’s strategic decisions.
• Contribute to the development of the company’s overall infrastructure and growth strategy. Collaborate with executive leaders and BOD in developing overall company strategy, meeting business objectives, and attracting/developing talent.
• Responsible for developing the product portfolio strategy to bring novel programs to market in compliance with global regulatory.
• Provide clinical and scientific input into Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology PoC, nonclinical toxicology, biomarker strategy, and IND enabling studies to develop optimal translational medicine approaches to facilitate development to clinical PoC.
• Ensure smooth transitioning of development candidates/programs from research through development and into commercialization.
• Actively engage and drive business development opportunities that support corporate strategy. Play a key role in the identification and evaluation of potential licensing and/or partnering opportunities.
• Drive internal and external collaboration by continually seeking and implementing innovative solutions; create a culture that thrives on progress and results.
• Functional responsibility for all clinical development activities from pre-clinical through Phase III programs and eventually on-market products for each program, including providing content for clinical development and other sections, as needed, including contributing to regulatory affairs, medical affairs, pharmacovigilance, biometrics and data management to ensure a successful product approval and launch.
• Develop a strategic roadmap for the company’s product portfolio to ensure development programs meet quality and safety standards required by medical and regulatory agencies.
• Identify and establish relationships with leading KOLs and principal investigators, including organizing and running KOL meetings, as needed.
• Organize and present at relevant clinical advisory boards and medical/scientific meetings.
• Orchestrate and manage clinical development in alignment with internal regulatory strategies and guidance from health authorities.
• Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
• Represent the Company and its programs to external audiences, including the investment, medical and academic communities, as well as pharmaceutical or biotechnology industry collaborators/partners.
• Serve as an advocate and champion for patients.

We seek candidates with the following qualifications:

• A medical degree (or equivalent) with significant pharmaceutical/biotech industry experience is required.
• Must have a minimum of 10 years of immunology drug development experience in pharma/biotech.
• Requires experience in immunology drug development.
• Experience in translational medicine, clinical pharmacology and early-stage development is desirable.
• Strong scientific background is required with experience in reviewing and interpreting scientific and study data is required.
• Requires medical monitor experience in clinical development.
• Must have multiple years of management experience leading clinical groups such as clinical research, clinical pharmacology, biometrics, translational medicine, medical affairs and clinical operations.
• Track records of scientific publications are strongly preferred.
• Must have working knowledge of applicable US and global regulatory requirements.
• Requires experience in building and maintaining effective relationships with external KOLs, advisory boards, and other key influencers in the therapeutic area is desirable.
• Must be a team player who works collaboratively in a challenging and fast-growing environment.
• The ability to work independently to resolve challenges and conflicts is required.
• Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can instill credibility and confidence within and outside the company; must have outstanding executive presence.
• Must possess excellent communication skills and will be capable of articulating the Company’s clinical development and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and our external community.
• Must be science- and data-driven and have the highest personal values and ethical standards.
• Integrity, honesty, the highest ethical standards and a sense of personal accountability is required.
• The ability to quickly adapt and provide innovative solutions to challenges as they present themselves is required.
• Requires the ability to travel on average 20% of the time (range 0-30% each month).
• Must be scientifically rigorous, highly organized, and with significant attention to detail.

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 40 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.