Senior Director, Assistant General Counsel

BioSpace; New York (NY); Hybrid; USD 180,000 - 320,000; Full time

Job summary

Protara Therapeutics is seeking a Senior Director, Assistant General Counsel to lead legal strategy and partner with R&D, Regulatory, Medical Affairs, and Commercial teams. The role focuses on FDA-regulated activities, clinical development, and strategic transactions in a highly regulated biotech environment.

The successful candidate will advise on product development, labeling, promotional review, and lifecycle management while ensuring compliance with healthcare laws and industry codes.

Qualifications

• Deep experience in biopharma law, regulatory affairs, and clinical development.
• Proven ability to advise on strategic transactions and product commercialization.
• Strong governance, risk management, and compliance orientation.

Responsibilities

• Advise senior leadership on legal, regulatory and business matters affecting oncology and rare diseases portfolio.
• Provide practical, risk-balanced legal guidance aligned with corporate objectives and patient-focused values.
• Guide on regulatory, healthcare and industry developments impacting the biotech sector.
• Support Board and executive management initiatives as needed.
• Counsel on clinical development, investigator-sponsored studies, and patient access programs.

Skills

Legal leadership

Regulatory affairs

Clinical development

Healthcare compliance

Negotiation

Tools

Contract drafting

Clinical trial agreements

Job description

Company Overview

Protara Therapeutics is a clinical‑stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA‑002, an investigational cell‑based therapy in development for the treatment of non‑muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA‑002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette‑Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Company Overview

Protara Therapeutics is a clinical‑stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA‑002, an investigational cell‑based therapy in development for the treatment of non‑muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA‑002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette‑Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes. Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation. Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

Job Overview

The Senior Director, Assistant General Counsel, serves as a legal leader and strategic business partner supporting Protara’s mission to develop and commercialize TARA 002 and IV Choline Chloride for patients with non‑muscle invasive bladder cancer, (NMIBC) and rare diseases.

Reporting to the Chief Legal and Compliance Officer, the incumbent will advise R&D, Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Market Access, Business Development, Manufacturing, and corporate functions to enable business objectives while managing legal and compliance risks in a highly regulated biotechnology environment.

This is a critical leadership role requiring deep experience in the biopharmaceutical industry, including expertise in FDA‑regulated activities, clinical development, strategic transactions, product commercialization, and healthcare compliance.

• This person must be able to come into the NYC office once a week.

Essential Duties and Responsibilities

include the following. Other duties may be assigned.

Strategic Legal Counsel

• Serve as a trusted advisor to senior leadership on legal, regulatory, and business matters impacting the company’s oncology and rare disease portfolio
• Provide practical, risk‑balanced legal guidance aligned with corporate objectives and patient‑focused values
• Advise on emerging legal, regulatory, healthcare, and industry developments affecting the biotechnology sector
• Support Board and executive management initiatives as needed

Clinical Development & Research Support

• Counsel stakeholders on legal issues related to clinical development, investigator-sponsored studies, expanded access programs, and patient support initiatives
• Review, draft, and negotiate agreements related to:
  • Clinical trial activities
  • CROs and vendors
  • Academic and research collaborations
  • Investigator agreements
  • Biomarker and translational research partnerships
  • Data‑sharing and real‑world evidence initiatives
• Provide legal support for global clinical trials and cross‑border research activities

Regulatory & Product Counsel

• Partner with Regulatory Affairs and Quality teams regarding FDA, EMA, and other global regulatory requirements
• Advise on product development, labeling, promotional review, scientific exchange, medical communications, and lifecycle management activities
• Support interactions with health authorities and advise on regulatory enforcement issues, inspections, and compliance matters
• Counsel business partners on evolving regulatory frameworks affecting oncology and rare disease therapeutics

Commercial & Medical Affairs Support

• Review and advise on promotional materials, disease‑awareness campaigns, digital initiatives, and medical communications
• Partner with Medical Affairs on scientific exchange, publication strategies, advisory boards, investigator engagements, and medical education programs
• Advise Commercial and Market Access teams on contracting, pricing, reimbursement, patient support programs, and interactions with healthcare professionals and institutions

Healthcare Compliance & Ethics

• Collaborate with Compliance leadership to ensure adherence to:
  • Anti‑Kickback Statute
  • False Claims Act
  • FDA promotional regulations
  • Sunshine Act/Open Payments requirements
  • HIPAA and privacy laws
  • Industry codes, including PhRMA and AdvaMed
• Conduct legal risk assessments and support investigations, audits, and corrective action initiatives
• Deliver training and guidance to business stakeholders on legal and compliance obligations

Business Development & Corporate Transactions

• Support licensing, collaboration, co‑development, co‑promotion, supply, manufacturing, and commercial partnership transactions
• Lead negotiation and draft complex strategic agreements
• Provide legal support for mergers, acquisitions, divestitures, joint ventures,