US Legal Director

4 weeks ago

San Francisco, California, United States Dompé farmaceutici S.p.A. Full time
US Legal Director

Job Area: Legal/Compliance

Job Category: Professionals

Job Site: Hybrid

Location: San Mateo, CA, US

The US Legal Director will provide a broad range of legal services and guidance to a rapidly growing biotech company, primarily providing advice and support to the commercial and medical affairs organization. The US Legal Director will be a partner to the organization providing seasoned 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.

Main Responsibilities:

  1. Providing seasoned, 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;
  2. Providing advice, education, and legal direction on healthcare fraud and abuse laws, 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;
  3. Counseling on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, and government entities;
  4. Serving as the brand attorney in support of key customer-focused groups; regularly interacts with team members in the commercial, medical affairs, and policy and payer departments;
  5. Participating in the multidisciplinary committee reviewing promotional, marketing, and advertising materials;
  6. Participating in the multidisciplinary committee reviewing medical affairs materials;
  7. 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;
  8. 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;
  9. 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 the commercial and medical affairs organizations, acting as a standing or ad hoc member of business or leadership teams.

Requirements:

  1. 8+ years of recent relevant experience counseling on matters related to the sales, marketing, and commercialization of bio/pharmaceutical products;
  2. JD degree with admission to the California Bar or Registered In House Counsel;
  3. 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;
  4. 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;
  5. Excellent oral and written communications skills;
  6. Demonstrated leadership and organizational savvy necessary to lead and collaborate effectively with cross-functional client teams;
  7. Strong ability to influence and present complex information to senior leaders and tackle challenging issues beyond the practice area;
  8. Proven ability to assess, calibrate, and effectively communicate legal risk;
  9. Demonstrated success in proactively and independently driving for and delivering results with high impact;
  10. Must thrive in a fast-paced, quickly evolving and growing environment and enjoy working on a variety of items each day;
  11. Operate independently with autonomy and limited supervision;
  12. Ability to travel domestically up to 30% of the time.

Skills:

  1. Network of support within legal and regulatory space;
  2. Excellent oral and written communication skills and interpersonal skills;
  3. Adept at forming and maintaining a collaborative work environment in and among cross-functional teams, including global teams;
  4. Ability to respond appropriately to needs of key stakeholders and manage expectations;
  5. Demonstrated ability to effectively manage time and set priorities in circumstances of conflicting requirements;
  6. Excellent project management skills and follow-through, as well as a proven ability to delegate and lead through others for key deliverables;
  7. Demonstrated ability to excel in smaller fast-paced entrepreneurial organizations;
  8. High performer with the ability to set a vision and provide clear direction across diverse internal and external stakeholders;
  9. Results-oriented;
  10. Self-starter who thrives in fast-paced, start-up environment;
  11. Critical thinker and active listener;
  12. Influential in driving outcomes and buy-in for ideas;
  13. Ability to manage multiple priorities and simplify approach based on priorities;
  14. The desire to actively solicit feedback on performance and skill development needs;
  15. Appreciation for diversity of perspectives and approaches among peers.

Salary: $180,000 - $235,000 a year. At Dompé, we offer an attractive compensation package to our team members, including a competitive base salary, 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.

Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

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