US Legal Director - San Mateo - Dompé farmaceutici S.p.A.

Description

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US Legal Director

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).

Job Summary

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.

Essential Functions

• 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.
  

Experience and Education

• 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.
  
• Substantial previous experience applying U.S. Healthcare laws in the context of real‑world bio/pharmaceutical business scenarios, and expertise in developing and implementing innovative solutions for complex legal matters.
  
• Other areas of legal capability and experience, including, but not limited to, governance, employment, litigation and privacy, are not required, but would be welcome to provide broader legal support as possible.
  
• Excellent oral and written communications skills.
  
• Demonstrated leadership and organizational savvy are necessary to lead and collaborate effectively with cross functional client teams.
  
• Strong ability to influence and present complex information to senior leaders and tackle challenging issues beyond the practice area.
  
• Proven ability to assess, calibrate, and effectively communicate legal risk.
  
• Demonstrated success in proactively and independently driving for and delivering results with high impact. Must thrive in a fast‑paced, quickly evolving and growing environment and enjoy working on a variety of items each day.
  
• Operate independently with autonomy and limited supervision. Ability to travel domestically up to 20% of the time.
  
• Strong contract negotiation, interpretation and drafting skills.
  
• Prior experience with collaborations, licensing agreements in the biotech industry.
  
• Results oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
  
• Network of support within legal and regulatory space.
  
• Adept at forming and maintaining a collaborative work environment in and among cross functional teams, including global teams.
  
• Ability to respond appropriately to needs of key stakeholders and manage expectations.
  
• Demonstrated ability to effectively manage time and set priorities in circumstances of conflicting requirement. Excellent project management skills and follow through, as well as a proven ability to delegate and lead through others for key deliverables.
  
• Demonstrated ability to excel in smaller fast‑paced entrepreneurial organizations.
  
• High performer with the ability to set a vision and provide clear direction across diverse internal and external stakeholders.
  
• Results‑oriented.
  
• Self‑starter who thrives in fast‑paced, start‑up environment.
  
• Critical thinker and active listener.
  
• Influential in driving outcomes and buy‑in for ideas.
  
• Ability to manage multiple priorities and simplify approach based on priorities.
  
• Teamwork & collaboration.
  
• The desire to actively solicit feedback on performance and skill development needs.
  
• Appreciation for diversity of perspectives and approaches among peers.
  

Benefits of Joining Our Team

• Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees
  
• Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle
  
• Competitive 401(K) matching
  
• Bay Area office with great views, located in vibrant downtown San Mateo and within walking distance to restaurants, coffee shops, and the Cal Train
  
• A super cool team who's excited to transform lives through innovative therapies
  

This role is considered hybrid with 3 days onsite requirement out of the Dompe US headquarters in San Mateo, CA. The role will occasionally require domestic travel and potentially internationally.

226,000 – 275,000 per year

At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law.

We believe that the unique contributions of all employees create our success. To ensure that our products and culture continue to incorporate everyone's perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status. xhmxlyz All your information will be kept confidential according to EEO guidelines.