Director, Legal & Compliance

Disc Medicine; Massachusetts; On-site; USD 180,000 - 260,000; Full time

Job summary

Disc Medicine in Massachusetts seeks a Director, Legal and Compliance to provide strategic legal and compliance guidance across commercial, medical, market access and R&D functions. The role supports data privacy programs and regulatory compliance to ensure the compliant launch of late-stage assets and ongoing clinical programs.

The successful candidate will review promotional materials, collaborate on product launches, enhance the compliance culture, and manage outside counsel.

Qualifications

• JD degree from an ABA-accredited law school.
• Active member of state bar in good standing.
• 10+ years experience in the pharmaceutical industry, at a law firm and/or in-house legal or compliance department.
• Comprehensive understanding of FDA regulations, healthcare compliance laws, and data privacy laws.
• Proven ability to partner effectively with teams to achieve business goals while mitigating legal risks.
• Experience supporting product launches and navigating the complexities of commercialization in the healthcare sector is highly preferred.

Responsibilities

• Provide strategic legal and compliance guidance to support business objectives across all departments.
• Serve as legal reviewer on promotional and medical review committees, advising on promotional materials and disease awareness materials.
• Collaborate with the commercial and medical affairs organization to navigate legal and compliance aspects of product launch and market entry.
• Enhance compliance culture and promote effective cross-functional initiatives.
• Partner with Data Protection Officer to support and enhance Disc’s global data privacy program in compliance with HIPAA, GDPR, and other applicable federal and state privacy laws.
• Conduct Data Protection Impact Assessments and privacy risk assessments across company initiatives, including clinical trials and other studies conducted by third-party vendors.
• Partner effectively with the broader Legal team, and with internal clients as a trusted strategic business partner.
• Contribute to enhancement of Disc’s compliance program, including by developing policies and trainings and supporting monitoring efforts.
• Develop and maintain knowledge of key laws, regulations, and industry guidance, including the Anti-Kickback Statute, False Claims Act, Food Drug and Cosmetic Act, state and federal privacy laws, and various industry guidance.
• Manage and coordinate work with outside counsel, as appropriate.

Skills

Strategic counsel

Cross-functional collaboration

Regulatory compliance

Data privacy knowledge

FDA regulations

Education

Juris Doctor (JD)

Active state bar

Job description

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.

POSITION OVERVIEW:

Disc Medicine is hiring a new Director, Legal and Compliance to provide sound legal and compliance counseling on a wide variety of strategic and tactical initiatives. The successful candidate will be a key member of the Disc Medicine legal team and will be responsible for providing strategic counsel across all departments including commercial, medical, market access, and R&D. The Director, Legal and Compliance will support Disc’s growing compliance and data privacy programs. This role will support all aspects of commercialization, including pre-launch activities, regulatory compliance, promotional review, and data privacy to ensure the successful and compliant launch of our late-stage therapeutic assets and advancement of our clinical programs. The Director, Legal and Compliance will report to the VP, Legal and Chief Compliance Officer and will work with all levels of employees, including senior management. The role requires sound judgment and flexibility to support the highly-regulated and compliant business. This newly-created, broad role could provide meaningful opportunities for professional development and career growth to the right candidate with experience in most areas of responsibility.

RESPONSIBILITIES:

• Provide strategic legal and compliance guidance to support business objectives across all departments
• Serve as legal reviewer on promotional and medical review committees, advising on promotional materials, disease awareness materials, dissemination of scientific communication, field sales training, and other materials
• Collaborate with the commercial and medical affairs organization to navigate legal and compliance aspects of product launch and market entry
• Enhance compliance culture and promote effective cross-functional initiatives
• Partner with Data Protection Officer to support and enhance Disc’s global data privacy program in compliance with HIPAA, GDPR, and other applicable federal and state privacy laws
• Conduct Data Protection Impact Assessments and privacy risk assessments across company initiatives, including clinical trials and other studies conducted by third-party vendors
• Partner effectively with the broader Legal team, and with internal clients as a trusted strategic business partner
• Contribute to enhancement of Disc’s compliance program, including by developing policies and trainings and supporting monitoring efforts
• Develop and maintain knowledge of key laws, regulations, and industry guidance, including the Anti-Kickback Statute, False Claims Act, Food Drug and Cosmetic Act, state and federal privacy laws, and various industry guidance
• Manage and coordinate work with outside counsel, as appropriate

REQUIREMENTS:

• JD degree from an ABA-accredited law school
• Active member of state bar in good standing
• 10+ years experience in the pharmaceutical industry, at a law firm and/or in-house legal or compliance department
• Comprehensive understanding of FDA regulations, healthcare compliance laws, and data privacy laws
• Proven ability to partner effectively with teams to achieve business goals while mitigating legal risks
• Experience supporting product launches and navigating the complexities of commercialization in the healthcare sector is highly preferred.