Associate General Counsel, Commercial (Senior Director)

Solid Biosciences•Boston, MA

38d•$285,438 - $328,702•Hybrid

About The Position

Solid Biosciences is seeking an Associate General Counsel, Commercial to serve as a legal advisor supporting the Company’s commercial, medical affairs, market access, patient advocacy, and pre-commercialization activities. This individual will provide pragmatic, risk-based legal advice across the product lifecycle, helping the Company successfully transition from a clinical-stage organization to a commercial-stage gene therapy company. This role will report to the General Counsel and will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA and is a hybrid position with remote amenability.

Requirements

Juris Doctor (J.D.) from an accredited law school.
Active membership in at least one U.S. state bar.
10-15+ years of relevant legal experience.
Significant experience in biotechnology, pharmaceutical, gene therapy, cell therapy, or life sciences industries.
Demonstrated experience negotiating complex commercial agreements.
Strong knowledge of FDA regulations and healthcare compliance laws.
Experience advising commercial, market access, medical affairs, and compliance organizations.
Exceptional drafting, negotiation, communication, and counseling skills.
Ability to work independently in a fast-paced, growth-stage environment.
Experience supporting product launches.
Familiarity with global commercialization and ex-U.S. markets.

Nice To Haves

Deep life sciences transactional expertise with strong knowledge of FDA regulations, healthcare compliance, commercialization activities, and the unique legal challenges associated with gene therapy products, including treatment-center networks, patient support programs, specialty distribution models, and global expansion.

Responsibilities

Lead drafting, review, negotiation, and management of complex commercial agreements, including: distributor, patient support services, market access, data licensing, speaker bureau, advisory board, and commercial manufacturing and supply agreements and develop scalable processes and templates to support commercialization.
Serve as primary legal partner to commercial leadership in preparing for product launch and advise on planning, promotional strategy, market development activities, patient engagement initiatives, and commercial operations.
Provide legal guidance regarding interactions with healthcare professionals, healthcare institutions, patient advocacy organizations, and payers.
Counsel internal clients regarding Federal Anti-Kickback Statute, False Claims Act, HIPAA and health privacy requirements, Sunshine/Open Payments obligations, FDA advertising and promotion regulations, State healthcare compliance laws, Patient assistance and support program requirements and develop and maintain an effective healthcare compliance framework, participate in review and approval processes for promotional and non-promotional materials, advise on Medical-Legal-Regulatory (MLR) review activities and interactions with key opinion leaders and healthcare professionals globally.
Advise on U.S. and international privacy laws impacting patient data, clinical data, and commercial activities.
Review digital health, patient engagement, artificial intelligence, and data analytics projects.

Benefits

Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
401(k) program participation with competitive company matched contributions
Eligibility to participate in Solid’s Employee Stock Purchase Plan
Mobile phone subsidy for eligible employees
Tuition Reimbursement
Vision Coverage
Life Insurance
Voluntary Pet Insurance
Employee Discount Program on Travel, Entertainment, and Services
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)