Description:
What if the work you did every day could impact the lives of people you know? Or all of humanity?At A Biotechnology Company, we are expanding access to genomic technology to realize
health equity for billions of people around the world. Our efforts
enable life-changing discoveries that are transforming human health
through the early detection and diagnosis of diseases and new treatment
options for patients.
Working at A Biotechnology Company means
being part of something bigger than yourself. Every person, in every
role, has the opportunity to make a difference. Surrounded by
extraordinary people, inspiring leaders, and world changing projects,
you will do more and become more than you ever thought possible.
VP, Legal - US1
Summary:
Responsible
for setting Legal vision, mission and strategy for Regulatory Affairs.
Evaluates, directs strategy and manages complex internal and external
legal issues, regionally and globally, in collaboration with management
and outside counsel.Key Responsibilities:
- Working directly with clients, provide strategic and practical legal counsel on a wide variety of drug and medical device development legal and regulatory issues.
- As a strategic partner, work to identify and advise on business and regulatory issues with important legal implications both independently and as part of a larger, global legal team.
- Collaborate with internal clients and Legal Department colleagues in different countries and across departments.
- Create and maintain a positive leadership image, providing strategic direction, positioning and effective communication/partnering to a team of legal professionals, including attorneys, paralegals and administrative support.
- Act as a strategic key point of contact for Legal advisory services for all regions (AMR, EMEA & APAC overflow), exercising significant influence with executive leaders. Serves as the internal legal expert but also external expert by maintaining influential outside contacts such as vendors and professional associations.
- Provides legal counsel to the highest executive levels regarding best practices, strategic advisement with respect to mitigating risk and to ensure legal compliance for Illumina. Provides strategic direction and legal counsel to all other levels with respect to Regulatory Affairs.
- This position will be remote, in Washington, D.C. and will report to the General Counsel who is located at Illumina headquarters in San Diego, CA. The V.P., Legal, Regulatory Affairs will have 1 direct report, a Sr. Director, Legal, Regulatory Affairs.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Qualifications Minimum Requirements
- J.D. degree or LL.M. degree from an ABA accredited law school, admission to practice law in a U.S. jurisdiction and at least 15 years of experience practicing law.
- 15+ years of experience as an attorney in a large law firm, biopharmaceutical company, or in a major government agency practicing law related to biotechnology, pharmaceutical, medical device and/or healthcare.
- Experience working with the FDA and the laws and regulations relating to the discovery, development, approval, sales & marketing of biotechnology/pharmaceutical/medical device products (including federal and state anti-kickback and healthcare/fraud and abuse laws).
- Experience with clinical and consultant contracts, and/or products liability.
- Excellent interpersonal skills.
- Ability to handle, prioritize and follow through on diverse issues on a timely basis.
- Resourceful and able to participate in highly collaborative, cross-functional team-oriented environment.
- Ability to meet demanding deadlines.
- Strong research and writing skills.
- Manage multi-dimensional projects in fast paced environment.
