Executive Medical Director
Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.
The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.
We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.
The Executive Medical Director is an integral member of the AveXis drug development organization and contributes significantly to the advancement of programs into and through the clinic. The near-term priority for this role is to champion the development of AVXS-101 for the treatment of SMA. The direct responsibilities of this position 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.
- Collaboration with the clinical operations, business strategy and commercial teams to optimize the success of AVXS-101.
- 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 Novartis Gene Therapies 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 and adhoc regulatory request.
- Educate Novartis Gene Therapies staff and external audiences on the science and clinical applications of the program.
- Present technical information to internal teams; represent Novartis Gene Therapies 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.
- May Build and establish relationships with external investigators
- Other Related duties as assigned.
- 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.
- Prefer a minimum of 1 year background in pharmaceutical industry.
The level of this position will be based on the final candidate's qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.