Manager, Legal & Compliance Operations
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 clinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.
Astria Therapeutics, Inc. is seeking a Manager, Legal & Compliance Operations to join our Legal team. The successful candidate will be responsible for collaborating with internal and external stakeholders to support the implementation and maintenance of Astria’s compliance program and provide support with Astria’s contract management system along with other Legal and Compliance projects.
Responsibilities
- Assist in the development, revision, and pull through of policies, procedures, and training
- Support implementation of needs assessment workflow and external funding reviews
- Support Astria’s cross-functional privacy initiatives and project plans to ensure on-track, timely completion in compliance with all applicable laws and codes
- Support execution of Compliance Committee materials and activities
- Assist with the review/negotiation of privacy language in various contracts
- Assist in operationalizing Astria’s compliance & legal training program, including collaborating with internal stakeholders on assignments and communications plans
- Transactional review of business activities, such as advisory boards, sponsorships/exhibits, and medical education initiatives for FCPA, fraud and abuse, FDA and other regulatory agency compliance, as well as in consideration of anti-kickback, anti-bribery, antitrust, privacy, laws, rules, regulations, and guidance
- Provide legal operations support including responding to questions regarding legal processes and the contract lifecycle management system
- Knowledge with SmartSheet and have proven track record in developing review and approval flows in SmartSheet
- Assist in operational tasks, as necessary
Qualifications
- Bachelor’s degree required
- 3 + years of compliance and or legal operations experience.
- Prior experience in the Pharmaceutical/Biotech/Life Sciences industry strongly preferred.
- Outstanding written communication skills with a proven track record partnering with business owners on writing and modifying policies & SOPs.
- Demonstrated pragmatism and operational focus, seeking to assist others in finding practical, business solutions.
- Strong oral and written communication skills.
- Must be detail-oriented, precise, and meticulous when reviewing data and records amid demanding deadlines.
- Previous privacy experience preferred.
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 diversity, equity, and 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.
