Description:
Salary Range:$285,438.00 To $328,702.00 Annually
Associate General Counsel, Commercial (Senior Director) – Solid Biosciences
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich's ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.
Patient-focused and founded by those directly impacted by Duchenne, Solid's mission is to improve the daily lives of patients living with devastating rare diseases.
We are 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.
Key Position Responsibilities
Experience Requirements:
Compensation:
Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid's long term company performance.
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich's ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.
Patient-focused and founded by those directly impacted by Duchenne, Solid's mission is to improve the daily lives of patients living with devastating rare diseases.
We are 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.
Key Position Responsibilities
- The ideal candidate combines 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.
- 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.
Experience 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.
Compensation:
- The base compensation range for this role is: $285,438 - $328,702
- Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid's long term company performance.
