Associate General Counsel, Healthcare Law (Sr. Director)

Company: Domp-- farmaceutici S.p.A.
Location: San Mateo
Posted on: May 29, 2023

Job Description:

Ciao! At Domp--, our success is rooted in our team and our history. We are a private, rapidly growing global biopharmaceutical company. Founded in Milan, Italy, we have a 165-year legacy of medical innovation. Domp--'s rich history has greatly influenced its priorities today: to innovate for the benefit of patients facing both everyday wellness needs and rare conditions. Domp-- operates in two strategic areas in select markets around the world: Primary Care, which includes prescription and over-the-counter products; and Biotechnology and Rare Disease, which recently expanded into the United States.Today Domp-- has 800 employees worldwide and we are excited to be rapidly scaling in the United States. Our R&D hub is currently based in Boston, and the commercial organization is housed in the San Francisco Bay Area.YOUR ROLE AT DOMP--Under the direction of Global Chief Legal Officer, the Associate General Counsel, Healthcare Law 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 Associate General Counsel 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. 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 and China will be growing in the coming years. Additionally with pipeline products Domp-- has the ability in grow rapidly with new franchises and the Director of Global Development & enrichment will be responsible for providing foundational structures and programs across the entire organization. The role will require the current candidate to have strong communication, relationship building, strategic thinking, and leadership skills to support their team in delivering on the core responsibilities. Also collaborating with the broader organization to evolve our employee development and enrichment strategy in the US as well as globally. As a Director, this individual is an integral part of the Domp-- leadership team and is responsible for overseeing the work of future direct reports and the work delegated to vendors to ensure quality and timely completion of deliverables or provision of services.WHAT YOU'LL BE DOING: MAIN RESPONSIBILITIES--- 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;--- 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;--- Counseling on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, and government entities;--- Serves 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;--- Participates in the multidisciplinary committee reviewing promotional, marketing and advertising materials;--- Participates in the multidisciplinary committee reviewing medical affairs materials;--- Collaborating with the compliance department to assure that appropriate policies and training programs for employees are implemented to support and sustain Domp--'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 opportunity 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.YOU COULD BE THE PERFECT FIT IF YOU HAVE:

• 12+ years of recent relevant experience counseling on matters related to the sales, marketing, and commercialization of bio/pharmaceutical products (preference of at least 10 years experience serving as in house counsel)
• JD degree with admission to 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.
• Excellent oral and written communications skills.
• Demonstrated leadership and organizational savvy 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 locally domestically and internationally up to 30% of the job requirementsSKILLS YOU'LL NEED FOR SUCCESS: TECHNICAL
  • Network of support within legal and regulatory space
  • Excellent oral and written communication skills and interpersonal skills
  • 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 stakeholdersSKILLS YOU'LL NEED FOR SUCCESS: PERSONAL
    • 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 peersBUILDING INTERNAL RELATIONSHIPS WITHIN DOMPE:
      • Global and US based Legal and Compliance
      • Marketing
      • Field Marketing
      • Market Access
      • Finance
      • Sales Leadership
      • Regulatory
      • Medical AffairsBUILDING EXTERNAL RELATIONSHIPS TO WORK WITH OUTSIDE OFDOMP--
        • External law firms, Government regulators, and moreBENEFITS 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
          • A super cool team who's excited to transform lives through innovative therapies
          • Bay Area office with great views, located in vibrant downtown San Mateo and within walking distance to restaurants, coffee shops, and the CaltrainWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: Domp-- farmaceutici S.p.A., San Mateo , Associate General Counsel, Healthcare Law (Sr. Director), Executive , San Mateo, California