US Legal Director

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Job Area:
Legal/Compliance

Job Category:
Professionals

Job Site:
Hybrid

Location:

San Mateo, CA, US

Dompé is an Italian bio‑pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand‑in‑hand with a commitment to research and development to meet unsatisfied therapeutic needs.

Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).

Under the direction of General Counsel, the US Legal Director will provide a broad range of legal services and guidance to a rapidly growing biotech company, primarily providing transactional support and advice and support to the commercial and medical affairs organization. The US Legal Director will be a partner to the organization providing advice on a variety of matters related to all stages of drug development, including regulatory issues, advertising and promotion, privacy, healthcare fraud and abuse, and general legal liability.

This position requires a self‑motivated attorney who consistently demonstrates excellent judgment and ethics when delivering solutions‑oriented, proactive, and strategic legal advice.

OXERVATE is a first in class treatment for neurotrophic keratitis, a rare disease impacting approximately 65,000 people in the United States. Given the first‑in‑class nature and strong clinical profile of OXERVATE, the US team, as well as our partners in Italy will be growing in the coming years. With a rare disease product, the US Legal Director will need to provide advice and support for the rare disease model, including disease awareness, patient advocacy and patient support services.

• Providing transactional support to the business, partnering with the European Legal Team as needed
• Providing risk‑based advice on a variety of matters related to all stages of drug development, including regulatory issues, advertising and promotion, healthcare fraud and abuse, and general legal liability.
• Providing advice, education, and legal direction on contracting and pricing, FDA labeling and promotional matters, patient support programs, managed markets, government pricing, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
  Counseling on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, and government entities.
• Collaborating with the compliance department to assure that appropriate policies and training programs for employees are implemented to support and sustain Dompé’s strong commitment to compliance with governing laws and regulations.
• Providing advice on and assistance in negotiating and documenting commercial relationships, compliance and business matters over a broad range of business relationships including vendors, collaborators, clinicians and business partners.
• Proactively identifying and seizing opportunities to create value and manage legal issues, fostering strong relationships with client groups, creating efficient and effective processes for working with clients, advising senior leaders in commercial and medical affairs organizations, acting as a standing or ad‑hoc member of business or leadership teams.

• 8+ years of recent relevant experience counseling on matters related to the sales, marketing, and commercialization of bio/pharmaceutical products.
• JD degree from an accredited law school and a member in good standing of the California Bar or Registered in‑house Counsel.
• Excellent current understanding of the U.S. Food, Drug and Cosmetic Act and related regulations, and U.S. healthcare fraud and abuse laws, including the federal False Claims Act and the Anti‑Kickback Statute, as well as up‑to‑date familiarity with guidance and enforcement priorities of government enforcement and regulatory agencies.
• Substanti…