Overview
US Legal Director at Dompé. Under the direction of the General Counsel, provide a broad range of legal services and guidance to a rapidly growing biotech company, primarily transactional support and advice to the commercial and medical affairs organizations. Partner with the organization on matters related to all stages of drug development, including regulatory issues, advertising and promotion, privacy, healthcare fraud and abuse, and general legal liability. Requires a self-motivated attorney with excellent judgment and ethics, delivering solutions-oriented, proactive, and strategic legal advice.
OXERVATE is a first-in-class treatment for neurotrophic keratitis. With growth in the US team and partners in Italy, the US Legal Director will provide advice supporting the rare-disease model, including disease awareness, patient advocacy and patient support services.
Responsibilities
- Providing transactional support to the business, partnering with the European Legal Team as needed
- Providing risk-based advice on 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 relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, and government entities
- Collaborating with the compliance department to ensure policies and training programs support Dompé’s commitment to compliance with governing laws and regulations
- Negotiating and documenting commercial relationships, including with vendors, collaborators, clinicians and business partners
- Proactively identifying opportunities to create value, manage legal issues, foster relationships with client groups, and advise senior leaders in commercial and medical affairs
Experience and Education
8+ years of relevant experience counseling on matters related to the sales, marketing, and commercialization of bio / pharmaceutical productsJD degree from an accredited law school and a member in good standing of the California Bar or Registered in-house CounselStrong understanding of the U.S. Food, Drug and Cosmetic Act and related regulations, and U.S. healthcare fraud and abuse laws (including the False Claims Act and Anti-Kickback Statute)Experience applying U.S. healthcare laws in real-world biotech / biopharma contexts and developing innovative legal solutionsWillingness to support broader legal areas (governance, employment, litigation, privacy) as neededExcellent oral and written communication skills; ability to lead cross-functional teamsAbility to influence and present complex information to senior leaders and manage legal riskProven ability to drive for and deliver results in a fast-paced startup environment; travel domestically up to 20%Strong contract negotiation, interpretation, and drafting skills; experience with collaborations and licensing in biotechSelf-starter with entrepreneurial mindset and ability to work with diverse stakeholdersTeam-oriented with strong interpersonal skills and ability to foster collaboration across global teamsBenefits
Comprehensive medical benefitsGenerous vacation / holiday time offCompetitive 401(K) matchingBay Area office in San Mateo with views and easy access to amenitiesCollaborative team focused on transforming lives through innovative therapiesLocation & Other Details
This role is hybrid with 3 days onsite at Dompé US headquarters in San Mateo, CA. Domestic travel required; occasional international travel. Salary range : 226,000 – 275,000 per year.
About Dompé
At Dompé, we offer a competitive compensation package and benefits, with the actual pay determined by experience, qualifications, location, and other factors permitted by law. We are committed to equal employment opportunity and do not discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, marital status, veteran status, or disability status. All information is kept confidential according to EEO guidelines.
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