US Legal Director

YOUR ROLE AT DOMPÉ

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 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. 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. 
 

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;
• 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;
• Participating in the multidisciplinary committee reviewing promotional, marketing and advertising materials;
• Participating 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 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 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:

• 8+ years of recent relevant experience counseling on matters related to the sales, marketing, and commercialization of bio/pharmaceutical products.  
• 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 domestically up to 30% of the time.

SKILLS 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 stakeholders 

SKILLS 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 peers