VP, Legal, Commercialization & Head of Compliance

Position Overview:

Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, Navenibart, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in preclinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.

The VP, Legal, Commercialization & Head of Compliance will report to Astria’s Chief Legal Officer. You will be responsible for providing strategic legal advice and support for the functions involved in Astria’s commercialization strategy, commercialization planning and pre-approval activities. This includes working closely with departments such as Commercial, New Product Planning, Market Access, Medical Affairs and Patient Advocacy. In addition, you will serve as Astria’s Head of Compliance, focusing on Astria’s healthcare compliance activities and privacy and personal data compliance program.  As Head of Compliance, you will have the overall responsibility of overseeing, evolving and developing a robust compliance program consisting of compliance practices, policies and procedures appropriate for Astria in the near-term and as it evolves and prepares for potential commercial launch.   

Responsibilities:

• Oversee and lead the compliance function, providing strategic direction and oversight.
• Serve as Chair of Astria’s internal compliance committee, and establish and implement other committees, as necessary.
• Evolve, develop, implement and maintain comprehensive healthcare, privacy/data protection and other compliance policies, practices and procedures.
• Ensure compliance with global healthcare, privacy/data protection and corporate compliance related requirements, industry standards and internal policies.
• Advise executive/senior leadership and leadership teams on legal and compliance-related matters
• Monitor and report on the effectiveness of Astria’s compliance program to relevant committees, leadership teams and the Board of Directors.
• Provide strategic compliance advice and helping to ensure Astria’s compliance with industry standards, company policies and applicable laws and regulations. 
• Provide legal counsel on all aspects of pre-commercialization and, when applicable, commercialization activities, including launch preparation, launch execution, market development, disease awareness, product communication, advertising and promotion, and strategic brand planning.
• Lead the development and delivery of compliance training programs within areas of responsibility.
• Lead or oversee risk assessments, audits, addressing reports of violations and internal and external investigations, disputes and litigation within areas of responsibility.  
• Maintain awareness of legislation, pharmaceutical, regulatory and policy initiatives relevant to areas of responsibility.
• Partner with the CLO and other members of the Legal/Compliance team to develop, implement, and manage the Legal/Compliance team and the provision of legal and compliance services for Astria, to include selection/management of outside counsel and other advisors, resource/workforce planning, long-range planning and budgeting.
• Develop and mentor others on the Legal/Compliance teams and within the company, as appropriate

Qualifications:

• JD from a top-rated accredited law school
• License to practice law in the US and in good standing
• At least 15 years of legal and/or compliance experience gained through a combination of law firm and in-house biotech/pharma experience
• Ability to handle multiple priorities in a dynamic and evolving environment
• Excellent oral and written communication skills with a demonstrated ability to present complex information accurately and concisely to influence others at all levels
• Proven capacity to cultivate strong client relationships and influence leadership, including ability to assess and help business colleagues handle risks in a highly regulated environment
• Strong analytical skills and demonstrated learning agility and a deep aptitude for science and data analysis
• Committed to teamwork and collaboration across multiple functional areas
• Proficiency with SharePoint, and Microsoft Office programs such as Word, Excel, Teams, and PowerPoint
• Availability to work on site at our Boston office two to three days per week

Astria’s Commitment: 

At Astria, we are committed to building a diverse team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patient-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions.

People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.    

#LI-Hybrid