Executive Medical Director - Clinical Development
We are seeking to recruit a physician executive who is experienced in neurology drug development as Executive Medical Director, Clinical Development. Reporting to VP, Clinical Development, this executive will be an integral member of the drug development organization and will contribute significantly to the advancement of programs into and through the clinic. The direct responsibilities of this position will cover Phase 1 through Phase 3 activities, expanding and advancing the company's programs from early clinical trial development to proof-of-concept and market approval. This will be a high profile and high impact position, responsible for executing and delivering on critical clinical milestones. The individual hired for this position will, therefore, have significant influence shaping the future of the company. Responsibilities:
- Evaluate and understand the unmet medical needs in SMA and other rare neurologic disorders.
- Establish and approve scientific methods underlying the design and implementation of clinical protocols.
- Design and manage clinical studies in collaboration with the Biometrics, Clinical Operations, and Medical Affairs groups, including supervising or writing protocols and managing the clinical programs.
- Recruit, guide, and motivate clinical investigators.
- Act as and/or supervise Medical Monitor for AveXis sponsored clinical trials as needed and provide adverse event safety monitoring and reporting.
- Author or supervise writing relevant sections of Clinical Study Reports, BLA reports, investigator brochures, and other clinical/regulatory/safety documents.
- Educate AveXis staff and external audiences on the science and clinical applications of the program.
- Present technical information to internal teams; represent AveXis externally where necessary through publications, presentations at scientific meetings and congresses.
- Assist in medical affairs activities which may include medical information efforts, FAQ document creation, health economic efforts, etc.
- Assist with business development and pipeline activities.
- MD or MD/PhD in Neurology or Pediatrics is strongly preferred; pediatric neurology training would be ideal. Physicians with training in other medical specialties will be considered, but must have substantial industry experience in design, oversight and reporting of CNS clinical trials.
- Minimum four to ten years' experience in the design, execution and evaluation of clinical trials, with an emphasis on phases 2-3.
- Substantive experience in the pharmaceutical/biotechnology industry and in-depth understanding of pharmaceutical regulatory requirements and their impact on the development of clinical trials and BLAs.
- An active network in key segments of the CNS field is strongly preferred. This will include KOLs, key research centers, patient advocacy groups and a variety of patient care organizations.
- Able to write clearly and succinctly in a variety of communication settings; open, transparent and succinct communication skills, both verbal and written.
- Experience designing and managing clinical trials.
- Familiarity with statistics.
- Advanced knowledge of Microsoft Word, Excel and PowerPoint preferred (knowledge of Gmail, Google Apps and Adobe Acrobat desired).
- 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.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.