Description:
The Senior Corporate Counsel, Commercial, is accountable for providing legal support to A Biotechnology Company's Commercial and Medical Affairs groups at a strategic and operational level for the launch of A Biotechnology Company's first product, a gene editing therapy in Phase 3 development for hereditary angioedema (HAE). The role requires strategic thinking and excellent execution. The position is diverse and demanding, requiring a broad range of experience and a desire to provide legal counsel across a growing and fast-paced organization.Duties/Responsibilities:
- The Senior Corporate Counsel will provide primary legal support for the launch of A Biotechnology Company's first product by working closely with leadership teams and other employees on all aspects of the commercial business.
- The Senior Corporate Counsel provides timely and strategic counsel to the program and launch teams on strategic and tactical initiatives with respect to relevant legal and regulatory requirements, including, for example, patient support programs, market access activities, advisory boards, patient ambassadors, speaker programs, and market research.
- The Senior Corporate Counsel identifies issues and collaborates with colleagues of all levels to find solutions to critical problems early in the strategic development process, and reviews strategic and tactical plans and various medical, promotional, and educational materials.
- The Senior Corporate Counsel serves on various A Biotechnology Company committees, including the medical, access, commercial committee (MAC); commercial, medical, legal regulatory committee (C-MLR); grants and sponsorships committee (GSC); and medical review committee (MRC).
- The Senior Corporate Counsel plays an integral role in enhancing A Biotechnology Company's compliance program, including drafting and implementing policies, preparing and delivering trainings, and preparing monitoring plans.
- As part of a growing business, the Senior Corporate Counsel will have the opportunity for a diverse workload with support of other business activities.
- The Senior Corporate Counsel will work with all levels of employees, including senior management. This role requires experience, good judgment and flexibility in a highly-regulated and compliant business. This role provides the opportunity for visibility as a leader in the organization.
Requirements:
Skills/Abilities:
- Knowledge of laws and regulations pertaining to the commercialization of biopharmaceuticals
- Knowledge of the biopharmaceutical business and understanding of key commercial activities, including sales and marketing, product distribution, market access, and patient support services
- Significant experience with business counseling, and promotional and medical materials review (both pre-launch and post-launch)
- Established leadership skills, both within business project and process teams and within law departments
- Prior experience supporting the commercial organization in small-to-medium-sized biotechnology company
- Experience supporting the launch of rare diseases products
- Strong communications skills, both verbal and written
- Solutions-oriented mindset; cross-functional team player
- Exceptional organizational skills and attention to detail
- Solid track record of building strong working relationships in a cross-functional matrix environment and working with different personality types
- Strong work ethic; positive outlook; commitment to legal and business teams
- Collaborative style; team player
JD, licensed to practice law in at least one US State
Experience:
- 12+ years practicing law
- Minimum of 8 years of relevant experience including regulatory and commercial support
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer