Vice President/Senior Vice President, Medical Affairs

Vice President/Senior Vice President, Medical Affairs

About Audentes Therapeutics

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases.  We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown.  Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.

Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.

Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.

The Role

Reporting to the Chief Medical Officer, the Vice President/Senior Vice President, Medical Affairs will be a key member of the Development Leadership Team. The Vice President, Medical Affairs will lead the continued development and execution of a Medical Affairs strategy, including external stakeholder management, communication, patient identification, evidence generation, publications and medical education. Audentes develops therapies in the highly innovative and specialized field of rare disease gene therapy, and will require a creative thinking, visionary, collaborative and curious individual to lead the Global Medical Affairs function. The position will be located in our San Francisco offices.

The specific responsibilities of this position include:

• Lead and continue to develop a capable Global Medical Affairs organization by developing/implementing a strategy, identifying and directing appropriate resources and attracting and retaining top talent
• Lead the development of Global Medical Affairs and associated activities including Strategic Publication Planning, Medical and Scientific Advisory Boards, Educational Programs, Conferences, and responding to requests for medical information
• In partnership with Commercial, develop patient finding and diagnostic initiatives, and present to groups of strategic importance
• Continue to build on established professional relationships with the Key Opinion Leader community, and develop new relationships as appropriate to exchange scientific knowledge and identify current and future business opportunities, patients both for clinical trials and commercial planning and understanding medical and health care practices
• In partnership with Clinical Development, lead the planning and implementation of Phase IV Studies, Registries and Disease Monitoring Programs and other relevant post-marketing commitments
• Collaborate internally with clinical and regulatory departments to support the planning, execution and management of clinical trial activities. Support registrational studies through site identification, patient identification, key opinion leader engagement through medical activities and clinical trial recruitment initiatives
• Evaluate health economics landscape in each disease area and establish an outcomes research plan that can support reimbursement and commercial activity
• Hold the overall management responsibilities and leadership for the company's Medical Affairs organization in meeting corporate goals and objectives while keeping in compliance with applicable policies and regulations
• Continue to build and grow an external field team of Medical Science Liaison officers
• Build a Medical Information function to respond to external requests for information regarding compounds in development and approved products
• Collaborate with internal stakeholders to ensure timely, accurate and compliant preparation and review of promotional and educational material
• Develop and lead KOL speaker programs on Audentes' disease state, current therapeutics and patient care gaps
• Work with internal team to develop key messages on disease state, MOA, target product profile, molecular diagnosis, etc.
• Represent Audentes as an organization, and present data at advisory boards, clinical investigator meetings, congresses, etc.
• Remain on the forefront of the relevant science and competitive landscape

Required Education, Skills and Experience

• Board Certified MD with 15+ years' medical affairs experience including a role as a Vice President and clinical development within pharmaceutical or biotech industries.
• Track record of success in building and leading teams and strong managerial experience, cultivating a high performance organization; effective as a mentor and coach; able to attract, develop, motivate and retain key talent.
• Strong innovator with medical affairs strategy and accurately anticipate future consequences and trends.
• Well-grounded in drug development with extraordinary leadership competencies and the strategic business perspective needed to bring products forward successfully.
• In-depth experience in partnering with Patient Advocacy organizations in a compliant manner; communicating with representatives from such organizations; and successfully managing their expectations.
• Demonstrated leader who leads by example and model collaborative behavior by soliciting opinions, coupled with the ability to make key decisions and be effective in getting the team behind the decisions.
• Excellent written and verbal communication and high-level negotiation skills; strong presentation skills are important
• Interacts and communicates openly and effectively with internal team, external opinion leaders, regulatory bodies and development team members.
• Strong analytical skills, especially with regard to understanding and interpreting scientific and clinical research and literature are essential.
• Demonstrated self-starter and team player with strong interpersonal skills.
• Adept, nimble, energetic and comfortable in a fast-paced, dynamic and collaborative environment.
• Capable of taking a hands-on approach and willing to "roll up one's sleeves."
• Strong computer skills including MS Office (Word, Excel, PowerPoint)
• Commitment to Audentes' values: Be Bold, Care Deeply, and #GSD
• Travel up to 40%, including internationally.

Preferred Education, Skills and Experience

• Gene therapy experience
• Rare disease experience