Location: New York, NY
Axsome Therapeutics is currently searching for a Counsel/Senior Counsel role to provide comprehensive legal, regulatory, and healthcare compliance support to support Axsome Therapeutics’ ongoing commercialization efforts.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders.
The Axsome team is comprised of a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders.
Axsome is based in New York City, New York.
The Counsel/Senior Counsel role will be responsible for providing comprehensive legal, regulatory, and healthcare compliance support primarily to the Commercial team as they prepare for upcoming commercial launches. In addition, this person will serve in a generalist role supporting various matters including general business contracts and other corporate counsel functions to support Axsome Therapeutics’ commercialization efforts.
- Partner with commercial, regulatory, and medical colleagues to ensure timely review of promotional and some non-promotional materials. Contribute actively to the review team by evaluating potential risk and providing counsel.
- Provide legal advice and assistance related to commercial programs, including patient assistance, marketing programs and promotional campaigns in accordance with laws and internal policies.
- Manage the operational aspects of the development and administration of the Company’s corporate compliance program which includes Policy/SOP development, training, auditing/monitoring and reporting.
- Responsible for coordinating all policy development across the organization and also for coordination of policies with external partners/vendors.
- Develop functional plans for managing legal matters, including activities to be performed in-house or through outside counsel to best manage company’s legal activities and minimize risk for the business.
- Collaborate with IT to evolve the Company’s compliance-related systems.
- Partner with various business functions to explore ways in which monitoring-related data may be used to support business strategy and objectives in a compliant manner.
- Be committed to meeting patient unmet needs and be energized by rising to new challenges and coming up with creative yet compliant solutions to serve patients
- Understand and actively provide legal analysis and advice related to new and existing strategies
- Exercise judgment during times of ambiguity or conflict while providing guidance
- Proactively monitor latest development in key areas of Legal expertise that have an impact on current and long-term profitability of the company
REQUIRED EDUCATION AND EXPERIENCE
- Law degree and admission to at least one State Bar (New York Bar admittance strongly preferred). Minimum 10 years of relevant work experience at a large law firm and/or pharmaceutical/biotechnology, with significant experience developing U.S. compliance programs
- Familiarity with FDA regulations, federal fraud and abuse laws, including FDA/OIG guidelines, False Claims Act, Anti-Kickback Statute, Industry Codes and privacy laws and requirements affecting promotional, commercial, and medical activities
- Extensive experience with compliance matters relating to the development, approval and commercialization of pharmaceutical products. Ideal candidate will have been in a U.S. compliance role
- Experience with product launches including accelerated approvals
- Ability to work in a fast-scaling organization, collaborate with business partners, influence peers and interact with both senior management and leadership in Marketing, Field Sales, Medical, and Market Access teams.
- Ability to manage and serve a wide range of stakeholder groups by recognizing and responding quickly and pragmatically to urgent situations.
- In-depth understanding of business objectives and how those translate into healthcare compliance priorities to deliver advice and guidance to the business.
- Excellent interpersonal and influencing skills, an inquisitive mind, and the ability to work effectively in an entrepreneurial environment with multiple functions, together with a positive attitude and strong work ethic.