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Executive Director/Director of Medical Affairs
New York City, NY

Company

Founded in January 2018, Neurogene Inc. is a start-up biotech company focused on developing disease modifying therapeutics for severe neurologic diseases. The Company’s pipeline includes multiple gene therapy products for ultra-rare diseases, as well as a novel technology that has the potential for use in monogenic autism spectrum disorders and indications not well suited for gene therapy. Neurogene Inc. is sponsoring research, working closely with leading universities, and will continue to in-license programs to support drug discovery. The Company has secured lab space for early stage gene therapy manufacturing and is planning to build its own GMP manufacturing facility to support its strategic plan. Neurogene Inc. is currently self-funded and plans to secure a Series A round of financing in the next few months to support its ambitious objectives.

Rachel McMinn, Ph.D. founded Neurogene Inc. with the mission to provide long overdue medicines to improve the lives of neurologically impaired and developmentally delayed children and their families. Dr. McMinn currently serves as President and CEO of Neurogene Inc., and prior to that spent 17 years in biotechnology. Previously, she served as the Chief Business and Strategy Officer of Intercept Pharmaceuticals, a company dedicated to improving the lives of patients with serious liver disease. Prior to that, Dr. McMinn was an award-winning biotechnology analyst at Bank of America Merrill Lynch, Cowen, and Piper Jaffray.

Neurogene Inc.’s management team consists of experienced leaders from the biopharma industry including executives from AveXis, Pharmasset, Novartis, Intercept and Lonza.  The company is headquartered in New York City.

Responsibilities

Neurogene Inc. seeks to recruit an Executive Director/Director of Medical Affairs, who will provide expert medical, scientific, strategic and operational leadership across multiple parallel programs in different neurologic genetic disorders. Reporting to the Chief Medical Officer, the Executive Director of Medical Affairs will focus on building external relationships with relevant disease experts, patient foundations and advocacy groups. The individual will be responsible for creating educational content for use both internally and externally for physicians and patients, organizing medical advisory boards, contributing to the development of a publications and conference strategy, overseeing Medical Science Liaisons and collaborating with Clinical Development colleagues in the review of clinical data, protocols and of relevant sections of regulatory documents. In addition, this individual will work closely with Patient Engagement colleagues to support patient identification efforts. Importantly, this individual will need to be able to work very closely within a cross-functional team, while having the ability to work independently in a fast-paced environment. Ideally, the candidate will be located in/relocate to the New York City area; however, our Client may have some flexibility regarding a virtual location or commuting situation.

Specific responsibilities include:

  • Developing and nurturing thought leader relationships and collaborations within the medical community of lysosomal storage disease, pediatric neurologic disease, genetics and gene therapy, in order to execute Medical Affairs initiatives.
  • Closely collaborating with internal Patient Engagement colleagues to develop and nurture relationships with key patient advocacy group leaders and patient identification experts.
  • Developing and leading society relationship management plan.
  • Developing a publications strategy and data dissemination plan.
  • Creating educational materials for internal and external use.
  • Representing Medical Affairs at regional and international conferences.
  • Driving or contributing to planning, content development, leading of advisory boards, expert panels and family meetings.
  • Providing medical expertise to cross-functional projects (e.g. provide medical guidance on patient identification efforts, educational website and Facebook pages).
  • Close collaboration as needed with Clinical Development in the execution of natural history and clinical studies.
  • Contributing to the analysis, assessment and interpretation of natural history and clinical study data, in addition reviewing relevant regulatory documents.

Qualifications

The ideal candidate will possess excellent Medical Affairs experience contributing to the development and execution of Medical Affairs-specific activities. An M.D. is required. The successful candidate executes medical affairs initiatives independently and works collaboratively with colleagues to deliver on these initiatives. Although some experience in pediatrics, neurology, rare diseases and/or gene therapy would be ideal, it is most important to recruit someone who understands best-in-class drug development and the urgency to advance medicines to sick patients with no available treatment options. Most importantly, this individual will be passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.

Specific qualifications include:

  • Minimum of 5 years of Medical Affairs experience within the biopharmaceutical industry. Gene therapy, rare disease and/or pediatric neurology experience highly preferred.
  • MD required from an accredited institution.
  • Demonstrated track record of success in leading the development and execution of Medical Affairs strategy and initiatives.
  • Ability to create an active network with KOLs, key research centers, patient advocacy groups and a variety of patient care organizations.
  • Ability to develop educational materials.
  • Ability to manage Medical Science Liaisons.
  • Proven leadership and critical decision-making skills.
  • Exceptional analytical, critical thinking, and problem-solving abilities; strong attention to detail.
  • Demonstrated organizational and collaboration skills.
  • Ability to deliver professional and quality work products while working on multiple projects.
  • Desire and ability to work in a fast-paced, dynamic start-up environment.
  • Thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
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