Vice President, Commercial Product Law

Location
94080, South San Francisco
Posted
Jul 09, 2018
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

VICE PRESIDENT, COMMERCIAL PRODUCT LAW

Position Summary:

Global Blood Therapeutics (GBT) is seeking a seasoned attorney for the Company’s first Vice President, Commercial Product Law.  This position will serve as the lead US commercial attorney providing strategic counsel to the medical, commercialization and patient/advocacy teams team on a broad array of matters in support of the Company’s product portfolio, pre-launch and launch activities, including product launch planning, promotional support, and compliance (in coordination with GBT’s Chief Compliance Officer).  This position will report to the Chief Legal Officer (CLO) and will work collaboratively with a cross-functional commercial team, the Legal team and with outside counsel.

Essential Duties and Responsibilities:

  • Serves as lead attorney and strategic legal business partner to the GBT commercial, medical and regulatory affairs teams, as well as patient advocacy/support teams, in connection with GBT’s efforts to commercialize product candidates.  Serves on product launch teams
  • Provides comprehensive and high quality legal support to GBT in the areas of sales, marketing, promotional/medical/patient materials, patient access/support/ reimbursement, government contracts and pricing, managed care, and compliance with federal and state statutes, FCPA, rules and regulations, privacy, product liability law, and other laws, regulations and Company policies and procedures
  • Works collaboratively with Legal team partners (especially the CLO and Chief Compliance Officer) and key functions within GBT on all relevant topics.  Includes coordination with the VP, Corporate Law (e.g. on financings, disclosures and contracting), and with the VP IP (on publication review and IP/product lifecycle)
  • Partners with functional teams to establish a rapport and positive working relationship engaging legal counsel in the achievement of business objectives in the areas of commercial, regulatory, compliance, medical and patient advocacy activities and initiatives
  • Works collaboratively and creatively with stakeholders and provides broad spectrum legal support and day-to-day counseling. Clearly and effectively renders practical, timely legal advice
  • Drafts, review sand negotiates various commercial contracts including wholesale distribution agreements and vendor/fee-for-service arrangements
  • As requested, serves as primary Legal advisor in the negotiation and settlement of business disputes or product liability matters to protect the Company's interests
  • Performs special projects as assigned and demonstrates leadership ability on a wide range of issues
  • Identifies training needs within client groups and assists in the development and presentation of training (including in coordination with the Chief Compliance Officer on compliance-related topics)
  • Manages outside counsel to achieve timely and cost-effective work
  • Maintains a very strong working knowledge of applicable laws, regulations, and enforcement actions to identify emerging risks. Alerts the Company to trends and risks and assists in implementing policies and procedures in response thereto

Qualifications:

  • 10+ years legal experience including at least 5 years at a commercial-stage pharmaceutical or biotechnology company involved with product launches
  • JD degree from an accredited law school; licensed in good standing with California state bar strongly preferred
  • Broad knowledge of and significant legal experience counselling commercial and other functions in anti-kickback, FDCA, OIG, privacy, FCPA and other statutes, regulations, guidances, enforcement, and trends applicable to the development, marketing and sale of pharmaceutical products, especially the US environment.  Global experience preferred
  • Experience supporting pre-launch and launch activities for bio-pharmaceutical
  • Experience reviewing advertising, copy and promotional materials, conducting product reviews, advising on reimbursement and patient support activities and reviewing product labels
  • Experience drafting and negotiating pharma-related commercial contracts (e.g. supply, manufacturing, distribution, IST/clinical trial, managed markets, vendor) and/or other agreements
  • Proven ability to think strategically about achieving corporate objectives by addressing the needs of internal and external stakeholders
  • Excellent communication, negotiation, training and presentation skills and ability to interact with all levels of the organization
  • Strong organizational, project-management and teamwork skills required
  • Self-motivated, innovative, strategic, detail-oriented and able to provide high quality and timely work product
  • Able to manage multiple projects and work successfully in a fast-paced environment under time deadlines
  • Ability to analyze issues and propose options and recommended course of action
  • Ability and track record of successfully working in cross-functional teams
  • Strong client service orientation and business acumen
  • Demonstrated success in a fast-paced, high-performing, fluid, and collaborative culture
  • Ability work to collaboratively with individuals having diverse educational and cultural backgrounds
  • Ability to travel as necessary

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.