Associate General Counsel (Commercial)

Orca Bio•Menlo Park, CA

39d•Remote

About The Position

Reporting into our SVP, Legal, the Associate General Counsel will lead the commercial legal function with primary responsibility to support our first U.S. product launch. This individual serves as a trusted strategic partner and provides practical, timely and business-savvy legal advice to the Commercial (Sales, Marketing, Market Access), Medical Affairs and Patient Support functions. This role is the subject matter expert (SME) on U.S. healthcare laws, FDA promotional regulations and industry codes to enable legal and compliant pre-launch, launch and ongoing commercial and medical activities. This role partners with and may oversee Compliance to ensure that the Company’s U.S. compliance program remains risk-based, fit-for-purpose and aligned with our corporate values, while supporting cross-functional teams through advisory responsibilities, training and policy development. The ideal candidate will combine a strategic and seasoned mindset with hands-on tactical and operational excellence.

Requirements

JD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech preferred)
Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, and industry codes, and ability to stay current on evolving trends and enforcement
Experience reviewing promotional and medical materials
Ability to interpret and apply healthcare laws to complex business plans
Experience supporting product launch planning and cross functional review committees (experience building for first US launch preferred)
Strong business partnering skills with ability to balance risk and business goals
Excellent communication skills
Ability to manage multiple priorities in a fast-paced environment; comfortable working in a demanding start-up culture with evolving processes; flexible and able to adapt to new situations as the business demands

Responsibilities

Serve as key legal partner and SME to commercial and medical teams
Provide practical legal advice on pre-launch activities and launch strategy, including medical (e.g., MSL activities and programs), disease awareness, sales, marketing (brand messaging, activities and campaigns), marketing analytics, patient advocacy programs, advisory boards, incentive compensation for commercial personnel and other business activities
Counsel market access on pricing, reimbursement, distribution and contracting structures; advise on payer engagement issues including PIE and FDAMA 114; draft and lead the development of market access and patient support agreements; advise patient support team on legal issues related to patient support and hub services
Act as Legal representative reviewing content and messaging on Promotional Review Committee, Medical Legal Regulatory (Medical) Review Committee, Publications Review Committee, ISR reviews, grants and sponsorships committees and similar bodies
Training of applicable personnel
Oversee outside counsel; conduct and respond to diligence for financings, business development activities and the like as needed; and review other external corporate content such as press releases
Provide thought partnership to Compliance to advise commercial, medical, and advocacy teams on compliance obligations
Partner with Compliance to evolve the U.S. compliance program consistent with company size and scope and aligned with company values
Partner with Compliance to coordinate training activities including legal and compliance responsibilities, ethics, policies and procedures
Support development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes