Senior Director, Assistant General Counsel
Protara Therapeutics
August 10, 2026
Remote friendly (New York, NY)
United States
Corporate Functions
Job Overview
Senior Director, Assistant General Counsel (supports development and commercialization of TARA-002 and IV Choline Chloride).
Reporting & Leadership
- Report to the Chief Legal and Compliance Officer; advise R&D, Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Market Access, Business Development, Manufacturing, and corporate functions.
- Provide legal leadership and strategic risk-balanced guidance in a highly regulated biotech environment.
- Onsite requirement: NYC office once per week.
Essential Duties and Responsibilities
- Serve as trusted advisor to senior leadership on legal/regulatory/business matters for oncology and rare disease.
- Advise on emerging legal/regulatory/healthcare/industry developments; support Board/executive initiatives.
- Counsel on clinical development issues including investigator-sponsored studies, expanded access, and patient support; review/draft/negotiate agreements for clinical trials, CRO/vendor, collaborations, investigator agreements, biomarker/translational partnerships, and data-sharing/real-world evidence.
- Partner with Regulatory Affairs/Quality for FDA/EMA/global requirements; advise on product development, labeling, promotional review, scientific exchange/medical communications, lifecycle management, health authority interactions, inspections/enforcement, and regulatory frameworks.
- Review promotional/communications materials and campaigns; support scientific exchange, publications, advisory boards, investigator engagements, medical education; advise Commercial/Market Access on contracting, pricing, reimbursement, patient support, and HCP/institution interactions.
- Ensure compliance with Anti-Kickback Statute, False Claims Act, FDA promotional rules, Sunshine Act/Open Payments, HIPAA/privacy, and PhRMA/AdvaMed codes; perform legal risk assessments; support investigations/audits/corrective actions; deliver training/guidance.
- Support business development/corporate transactions (licensing/collaboration/co-development/co-promotion/supply/manufacturing/partnerships); negotiate complex strategic agreements; support M&A/divestitures/joint ventures; conduct due diligence and risk mitigation.
Supervisory Responsibilities: None currently (subject to change).
Qualifications
- J.D. from an accredited law school.
- Active U.S. state bar membership (at least one; NY or another state).
- 12+ years legal experience with significant in-house biotech/pharma/life sciences/healthcare.
- Preferred: experience supporting oncology/rare disease/specialty pharma/advanced therapy programs.
- Strong knowledge of FDA regulatory frameworks and pharmaceutical commercialization; clinical development and Medical Affairs support; contracts/transaction experience; prior law firm experience (preferred); deep biotech/pharma legal landscape.
Required/Preferred Skills
- Knowledge of FDA regulations, healthcare fraud/abuse, clinical trial regulations, data privacy/governance, commercialization/market access.
- Exceptional drafting, negotiation, and communication; balance legal risk with business objectives; sound judgment/executive presence; relationship-building/influencing; manage complex high-impact matters independently; strategic/analytical problem-solving; integrity/ethical leadership.
Preferred Qualifications
- Global biotechnology experience; oncology/hematology/cell & gene therapy/rare disease/orphan drug expertise.
- Specialty therapeutic launch/commercialization experience.
- International regulatory/compliance familiarity.
- Publicly traded biotech experience.
Computer Skills
- Proficient in Microsoft Office Suite.
Senior Director, Assistant General Counsel (supports development and commercialization of TARA-002 and IV Choline Chloride).
Reporting & Leadership
- Report to the Chief Legal and Compliance Officer; advise R&D, Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Market Access, Business Development, Manufacturing, and corporate functions.
- Provide legal leadership and strategic risk-balanced guidance in a highly regulated biotech environment.
- Onsite requirement: NYC office once per week.
Essential Duties and Responsibilities
- Serve as trusted advisor to senior leadership on legal/regulatory/business matters for oncology and rare disease.
- Advise on emerging legal/regulatory/healthcare/industry developments; support Board/executive initiatives.
- Counsel on clinical development issues including investigator-sponsored studies, expanded access, and patient support; review/draft/negotiate agreements for clinical trials, CRO/vendor, collaborations, investigator agreements, biomarker/translational partnerships, and data-sharing/real-world evidence.
- Partner with Regulatory Affairs/Quality for FDA/EMA/global requirements; advise on product development, labeling, promotional review, scientific exchange/medical communications, lifecycle management, health authority interactions, inspections/enforcement, and regulatory frameworks.
- Review promotional/communications materials and campaigns; support scientific exchange, publications, advisory boards, investigator engagements, medical education; advise Commercial/Market Access on contracting, pricing, reimbursement, patient support, and HCP/institution interactions.
- Ensure compliance with Anti-Kickback Statute, False Claims Act, FDA promotional rules, Sunshine Act/Open Payments, HIPAA/privacy, and PhRMA/AdvaMed codes; perform legal risk assessments; support investigations/audits/corrective actions; deliver training/guidance.
- Support business development/corporate transactions (licensing/collaboration/co-development/co-promotion/supply/manufacturing/partnerships); negotiate complex strategic agreements; support M&A/divestitures/joint ventures; conduct due diligence and risk mitigation.
Supervisory Responsibilities: None currently (subject to change).
Qualifications
- J.D. from an accredited law school.
- Active U.S. state bar membership (at least one; NY or another state).
- 12+ years legal experience with significant in-house biotech/pharma/life sciences/healthcare.
- Preferred: experience supporting oncology/rare disease/specialty pharma/advanced therapy programs.
- Strong knowledge of FDA regulatory frameworks and pharmaceutical commercialization; clinical development and Medical Affairs support; contracts/transaction experience; prior law firm experience (preferred); deep biotech/pharma legal landscape.
Required/Preferred Skills
- Knowledge of FDA regulations, healthcare fraud/abuse, clinical trial regulations, data privacy/governance, commercialization/market access.
- Exceptional drafting, negotiation, and communication; balance legal risk with business objectives; sound judgment/executive presence; relationship-building/influencing; manage complex high-impact matters independently; strategic/analytical problem-solving; integrity/ethical leadership.
Preferred Qualifications
- Global biotechnology experience; oncology/hematology/cell & gene therapy/rare disease/orphan drug expertise.
- Specialty therapeutic launch/commercialization experience.
- International regulatory/compliance familiarity.
- Publicly traded biotech experience.
Computer Skills
- Proficient in Microsoft Office Suite.