Vice President, Medical Affairs – Early Stage / Pipeline Products

Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The Vice President, Medical Affairs - Early Stage / Pipeline Products, will have overall responsibility for globally developing and executing the global medical affairs strategies and tactics for AveXis' portfolio of early stage assets and pipeline products focused on neurodegenerative diseases in partnership with the regional Clinical Development teams. This includes evidence generation, communication, and global external engagement. This role will report to the Vice President, Head of Medical Affairs.

Responsibilities

• Responsible for the early stage Global Medical Affairs plan for early stage development support neurodegenerative diseases aligned with AveXis' corporate strategy (e.g., Rett Syndrome and ALS) and tracking the execution of each tactic and in support of eventual launch teams.
• Partners with Clinical Development and Commercial functions in developing and implementing regional medical strategies for appropriate global lifecycle management.
• Develops and leads the execution of disease area of the overall Medical Affairs Strategy. Collaborates with the cross-functional teams (e.g., regional, commercial, clinical, compliance).
• Facilitate scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and medical value of AveXis' pipeline portfolio of assets in neurodegenerative diseases.
• Responsible for evaluating non-registrational clinical research globally, including: Investigator investigated trials (IIT), observational research, and Real World Evidence through registries.
• Serves as a global lead for scientific expertise in neurodegenerative diseases of interest (e.g., Rett Syndrome and ALS) and maintains in-depth understanding (scientific and clinical) of the disease state, product, competitors, marketplace, related medical areas and regulatory guidelines.
• Develops and delivers scientific presentations to internal and external audiences (reimbursement agencies, healthcare professionals, advocacy organizations and consumers as compliant, policy-making bodies, etc.).
• Supports robust scientific internal and external training activities and medical communication, including ensuring the successful dissemination of innovative clinical information to thought leaders.
• Develops and maintains positive professional relationships with thought-leaders based on mutual respect and reciprocal scientific information exchange related to medical therapies.
• Maintains budget responsibility for all early stage / pipeline related Medical Affairs activities.

Qualifications

• Scientific degree required, MD, DO, highly desirable.
• 10+ years of Medical Affairs experience required; minimum 8 years of progressive experience in the biotech or pharmaceutical industry, preferably in a similarly situated role in a small or mid-size company.
• Expertise in pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, preclinical and clinical development, clinical operations, commercial, compliance, regulatory, and medical affairs.
• Experience in preclinical and/or clinical development preferred.
• Neurology or neurodegenerative disease experience preferred.
• Experience or keen understanding and awareness of the cell and gene therapy space preferred.
• Existing global contacts with neurology research institutions and/or hospitals strongly preferred.
• Strong interpersonal skills commensurate with the need to effectively manage teams of peers and to work closely with both external physicians/scientists and numerous in-house support groups.
• Demonstrated ability to maintain scientific credibility while being commercially supportive, and to communicate scientific results and effectively respond to data queries from customers and/or consultants.
• Ability to maintain the highest degree of confidentiality and integrity, represent the company's high ethics, moral behavior, and professionalism. A genuine care for patients and their families.
• Must have a roll-up-your sleeves mentality and a passion for getting things done.
• Excellent planning and organization skills.
• High proficiency in problem solving ability and strong scientific analytical skills.
• Experience working with matrixed organization.
• Computer proficiency in all common IT work tools (e.g., Microsoft Office suite).
• Willingness/Ability to travel up to 70% and internationally at times is required.

This role is based at AveXis Headquarters in Bannockburn.

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.

AveXis 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.

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