Senior Director, Assistant General Counsel

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), as well as IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support. The company was named one of the Best Places to Work by BioSpace, emphasizing culture, career growth, leadership, and innovation.

About the role

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, this role advises 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 position requires coming into the NYC office once a week.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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, and other strategic initiatives.
• Conduct due diligence and advise on transaction-related risks and mitigation strategies.
• Draft, review, and negotiate a broad range of commercial and operational agreements.
• Manage outside counsel and legal spend effectively.
• Develop and improve contracting processes, templates, and legal operations efficiencies.
• Support enterprise risk management initiatives.
• Advise on data privacy and cybersecurity matters affecting clinical, commercial, and corporate operations.
• Counsel stakeholders on patient data, clinical trial data, secondary use of data, artificial intelligence initiatives, and cross-border data transfer issues and GDPR.
• Support implementation of privacy programs and governance frameworks.
• Build strong partnerships across business functions to foster a culture of compliance, accountability, and innovation.
• Contribute to strategic planning and legal department initiatives.

Qualifications

• Juris Doctor (J.D.) degree from an accredited law school.
• Active membership in good standing with at least one U.S. state bar.
• 12+ years of legal experience, including significant in-house experience within biotechnology, pharmaceutical, life sciences, or healthcare organizations.
• Demonstrated experience supporting oncology, rare disease, specialty pharmaceutical, or advanced therapy programs preferred.
• Strong knowledge of FDA regulatory frameworks and pharmaceutical commercialization.
• Experience supporting clinical development and Medical Affairs organizations.
• Significant contracts and transaction experience, including strategic collaborations and licensing arrangements.
• Prior law firm experience preferred.
• Deep understanding of the biotechnology and pharmaceutical legal landscape.
• Strong knowledge of:
  • FDA regulations
  • Healthcare fraud and abuse laws
  • Clinical trial regulations
  • Data privacy and data governance requirements
  • Commercialization and market access issues
• Exceptional drafting, negotiation, and communication skills.
• Ability to balance legal risk with business objectives in a fast-paced environment.
• Sound judgment and strong executive presence.
• Excellent relationship-building and influencing skills across all organizational levels.
• Demonstrated ability to manage complex, high-impact matters independently.
• Strategic thinker with strong analytical and problem-solving capabilities.
• High integrity and commitment to ethical leadership.

Preferred Qualifications

• Experience supporting global biotechnology organizations.
• Expertise in oncology, hematology, cell and gene therapy, rare disease, or orphan drug programs.
• Experience with launch and commercialization of specialty therapeutics.
• Familiarity with international regulatory and compliance frameworks.
• Experience supporting publicly traded biotechnology companies.

Skills

• Strong interpersonal skills, including ability to communicate effectively with diverse audiences and build strong relationships.
• Excellent written and oral communication and presentation skills.
• Ability to prioritize and multi-task successfully in a fast-paced environment.
• Excellent organizational skills and attention to detail.
• Ability to work with highly confidential information.
• Ability to manage both day-to-day operations as well as project work.
• Strong analytical and problem-solving skills.
• Ability to work both independently and in a collaborative team setting.
• Proficiency in data mining/data extraction.
• Demonstrated experience working with and presenting to senior level management.
• Ability to work through uncertainty.
• Proficiency in Microsoft Office Suite.

Must be a member of NY or another state Bar.

Benefits

• Competitive compensation package including incentive bonus and equity compensation.
• Matching 401(k).
• Medical, dental, and vision benefits.
• Commuter benefits.
• Fertility benefits.
• Generous paid holidays and unlimited PTO.
• Friendly, open, and fun team-oriented culture valuing unique and diverse perspectives.
• Flexible working hours/schedules.

Pay

Salary range is between $300,000 - $305,000 based on job-related knowledge, experience, education, and skills demonstrated.

Schedule

This position requires minimal travel; average travel is 5% with some variation based on business needs. The role requires coming into the NYC office once a week.