Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.
Mirum is seeking experienced counsel to serve as its primary attorney to lead and manage its Legal department. The candidate will play a key role in executing a broad range of legal activities for all business units within the company including corporate governance, contract negotiations, IP, data privacy matters, and securities compliance.
- Advise on all legal matters related to Mirum’s business activities, including healthcare legislation, privacy, product liability, securities, and other laws relevant to the commercialization of pharmaceutical products.
- Keep informed of new laws, rules and regulations and industry trends impacting Mirum’s business.
- Assist in the development and implementation of company policies and procedures.
- Provide strategic, practical legal advice to accounting, communications, investor relations, HR, stock administration, tax, and finance teams.
- Support corporate development in launching collaborations and integration efforts. Advise on contract interpretation issues and work with corporate development on maintenance and performance of existing partnerships and other commercial arrangements.
- Serve as the legal representative on the medical, legal, and regulatory (MLR) review committee.
- Manage outside legal counsel engaged by the company on matters requiring specialized knowledge or expertise.
- Collaborate with finance and business partners in international corporate structure design and implementation.
- Provide advice and guidance on contractual matters to the company’s contracts management team.
- Provide corporate governance support, including preparing board and committee meeting agendas and minutes, presentations, resolutions, and other materials.
- Ensure compliance with NASDAQ and SEC rules and requirements and assist with SEC filings, including Form 8-K, Form 10-K, Form 10-Q and proxy statements.
- Supervisory responsibilities, including department employee management and performance tracking; hiring and career development.
- J.D. degree from an accredited law school.
- Active member in at least one U.S. State bar.
- 15+ years of related experience in legal counseling role specifically related to pharmaceuticals, biotech or medical devices in industry or major law firm; ideally majority of time spent in-house.
- Experience providing advice on a broad range of legal issues, including GxP, quality, safety counseling, IP, and commercial transactions.
- International pharmaceutical/biotech experience a plus.
Knowledge, Skills and Abilities:
- Excellent interpersonal, communication, and presentation skills.
- Solid understanding of contracting concepts with experience negotiating complex agreements.
- 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 commercial and medical activities.
- Experience with product launches including accelerated approvals.
- Senior leadership and Board interactions.
- Strong analytical skills.
- Attention to detail.
To apply, please send your resume to email@example.com.