Medical Director

Our client is a rapidly growing clinical-stage biotechnology company dedicated to developing innovative medicines for immune and inflammatory disorders. They have retained us to assist in their search for a Medical Director.

Major tasks and responsibilities include:

• Provide and develop medical leadership across the company’s clinical development programs and plans.
• Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOLs, and patient advocacy groups.
• Establish and lead the overall Translational Medicine effort, integrating development and prioritization of therapeutic hypotheses, preclinical research, toxicology and biomarker assay development, with clinical strategies including pharmacology, regulatory and medical to design and efficiently complete first-in-human and proof-of-concept (PoC) trials.
• Contribute to activities in support of the company’s regulatory submissions, including authoring clinical sections for INDs, NDAs, and other related documents.
• Collaborate with Clinical Operations, Research, Program Management, CMC, and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to early-stage clinical development programs.
• Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing literature, attending medical/scientific meetings, and through personal interactions with consultants, thought leaders, investigators, and internal stakeholders.
• Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
• Provide medical information on existing and emerging data, in response to questions from internal and external stakeholders.
• Participate in safety review meetings and provide medical monitoring of ongoing clinical trials.
• Participate in the analysis and interpretation of data, ensure integrity of trial data, and assist in reporting of study results, including preparation of scientific summaries, abstracts, and manuscripts.

We seek candidates with the following qualifications:

• An advanced degree (MD,MD/PhD, or equivalent) with a minimum of 2+ years of pharmaceutical or biotechnology industry drug development experience required.
• Experience in inflammation and immunology is required.
• Must have preclinical and early-stage clinical development experience.
• Proven track record of regulatory experience, including interactions with FDA/EMA and submitting INDs/IMPDs and NDAs/BLAs/MAAs.
• The position requires strategic thinking and technical expertise in varied areas of research, medicine, and drug development.
• Experience developing clinical and biomarker strategies to develop and differentiate products in the market, to patients, prescribers, regulators, and payors.
• Strong collaborative skills that cross the scientific disciplines involved in R&D, along with a willingness to cross those boundaries.
• Excellent verbal, written, and interpersonal communication and presentation skills.
• Strong leadership skills to influence decision-making.

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.