Summary of Position:Scholar Rock is seeking an experienced biopharmaceutical attorney with rare disease product launch experience to serve as VP, Commercial Legal Counsel. The position reports to the General Counsel & Corporate Secretary and is a key partner to the U.S. commercial and medical affairs organization, responsible for providing strategic legal guidance related to Scholar Rock's planned commercialization activities.
Position Responsibilities- Provide legal advice on a wide range of commercialization issues with broad enterprise impact.
- Strategic legal partner for U.S. commercial and medical affairs organization.
- Advise business on advertising and promotional messaging, materials and activities, including serving on review committees to review and advise on promotional, medical, scientific exchange, and educational materials.
- Review and advise on interactions with external stakeholders, including patients, physicians, payors and patient advocacy groups.
- Provide strategic legal advice related to patient support programs, patient hubs, market access, pricing, reimbursement, and distribution channels and manage commercial contracting.
- Collaborate with compliance to ensure commercialization activities conducted compliantly, in accordance with applicable laws and company policies.
- Monitor healthcare regulatory laws and emerging legal trends, including FDCA and related regulations, fraud and abuse laws and guidance (Anti-Kickback Statute, False Claims Act, OIG guidance and advisory opinions), and assess their impact on Scholar Rock.
- Work closely and collaboratively with broader legal team on legal initiatives.
- Provide company-wide education/trainings on healthcare regulatory laws and emerging trends.
- Develop and mentor legal colleagues to help build a successful legal team.
Candidate Requirements- Juris Doctorate (J.D.) from a fully accredited law school.
- Admission to the Massachusetts bar.
- 15+ years of legal experience, with leadership experience at a commercial stage biopharma company preferred.
- Deep familiarity with healthcare compliance laws, including FDA advertising and promotion compliance.
- Exceptional executive-level written and verbal communication skills with ability to convey complex legal risks in clear, business-centric terms.
- Experience supporting rare disease product launches.
- Ability to maintain confidentiality and operate with high ethical standards and professionalism.
- Exceptional interpersonal skills and ability to work collaboratively in a fast-paced global environment.
- Hybrid schedule (in-office required for a portion of the week).
$325,000 - $400,000 a year
