Director, Legal & Compliance - Hybrid Biotech Launch

Disc Medicine; Massachusetts; Hybrid; USD 207.000 - 253.000; Vollzeit

Benefits dieser Stelle

Flexible work arrangements

Competitive compensation & benefits

Company headquarters in Watertown

Zusammenfassung

Disc Medicine in Watertown, MA, seeks a Director, Legal and Compliance to provide strategic counsel across commercial, medical, market access and R&D, supporting pre-launch activities, regulatory compliance, promotional review and data privacy to ensure a compliant launch of late-stage assets.

The ideal candidate has 10+ years in pharma industry, a JD from an ABA-accredited school, and a proven ability to partner with senior management while mitigating legal risk in a highly regulated

Qualifikationen

• JD degree from ABA-accredited law school.
• 10+ years in pharma industry or related regulatory/compliance roles.
• Strong knowledge of FDA regulations and healthcare compliance laws.
• Experience with data privacy programs (HIPAA, GDPR).

Aufgaben

• Provide strategic legal and compliance guidance to support business objectives across all departments.
• Review promotional and medical materials for compliance.
• Collaborate with commercial and medical affairs on launch and market access.
• Enhance compliance culture and cross-functional initiatives.
• Support data privacy program in HIPAA and GDPR compliance.
• Conduct privacy risk assessments across initiatives incl. trials.
• Partner with external counsel as needed.
• Develop policies and trainings to strengthen the program.

Kenntnisse

Leadership

Cross-functional collaboration

Regulatory affairs

Data privacy

FDA regulatory knowledge

Ausbildung

JD degree from ABA-accredited law school

Jobbeschreibung

Disc Medicine in Watertown, MA, seeks a Director, Legal and Compliance to provide strategic counsel across commercial, medical, market access and R&D, supporting pre-launch activities, regulatory compliance, promotional review and data privacy to ensure a compliant launch of late-stage assets.

The ideal candidate has 10+ years in pharma industry, a JD from an ABA-accredited school, and a proven ability to partner with senior management while mitigating legal risk in a highly regulated