Description:
What You'll Be Doing:The Executive Director, Legal at A Stealth Biotechnology Company will be responsible for leading the healthcare and commercial law function, including overseeing all legal functions relating to the launch and commercialization of A Stealth Biotechnology Company's oncology products.
This person will also be a key collaborator with the Commercial team and will work closely with cross-functional stakeholders across the A Stealth Biotechnology Company organization. This role reports to the VP, Legal and will be based in one of A Stealth Biotechnology Company's corporate offices (San Francisco or New York City) or remote in the U.S. (although may be required, as needed, to perform duties at A Stealth Biotechnology Company's corporate offices).
You will be responsible for…
- Act as lead brand attorney for A Stealth Biotechnology Company's first product candidate, advising on commercialization strategies, planning and execution, including with respect to sales, marketing, pricing, market access, medical affairs and regulatory strategies and initiatives
- Review and advise upon pre-approval, promotional and medical affairs materials
- Draft and negotiate high value commercial agreements including distribution, market access/rebate, GPO, specialty pharmacy, and patient hub and patient assistance agreements, as well as agreements with healthcare providers including advisory board and speaker bureau agreements
- Serve as an internal subject matter expert and provide practical guidance and legal advice to business partners on healthcare law and compliance matters relating to commercialization of pharmaceutical products in the U.S
- This includes FDA regulations, anti-kickback, fraud and abuse, privacy, government price reporting, pharmaceutical state licensing, and notification and reporting requirements
- Develop policies and training materials to support compliance with laws relating to commercialization of pharmaceutical products
- Advise on risk management with respect to commercialization of pharmaceutical products, including identification, prioritization, and mitigation of risk
- Manage the Commercial legal budget
- Juris doctor (J.D.) from an accredited law school
- Admission to a state bar and active license to practice law
- Minimum of 10 years practicing law in a pharmaceutical or biotechnology company legal department and/or well-recognized law firm
- Significant experience interacting with commercial, medical affairs, and research & development departments, and handling complex legal issues
- Specific expertise in the U.S. Food and Drug Administration advertising and promotion regulations, FDCA, False Claims Act, Anti-Kickback Statute, OIG Guidance, foreign anti-bribery laws, privacy laws, and US and ex-US transparency reporting laws and industry codes (e.g., Sunshine Act, US PhRMA Code)
- Experience with at least one pharmaceutical product launch preferred
- Strong organizational, interpersonal and people-management skills
- Strong critical thinking skills and the ability to grasp important business and legal issues and to appropriately balance risk mitigation with corporate objectives and priorities.
- Outstanding interpersonal and leadership skills, with the ability to build strong relationships across functions and to communicate effectively with senior business leaders, as well as other professionals and colleagues at all levels of an organization.
- Ability to work under pressure and meet deadlines
- Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with internal clients
- Dedication to quality and the highest professional and ethical standards
- Behavioral skills to be successful...
- Problem-Solver - As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
- Emotional intelligence, curiosity, and a knack to figure out a way to build something better
- Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
- Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
- Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
