Senior Director, Assistant General Counsel

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, and other strategic initiatives

Conduct due diligence and advice on transaction-related risks and mitigation strategies.

Contracting & Legal Operations

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

Privacy & Data Governance

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

Leadership & Cross-Functional Collaboration

Build strong partnerships across business functions to foster a culture of compliance, accountability, and innovation

Contribute to strategic planning and legal department initiatives

Supervisory Responsibilities: None currently, subject to change.

Education/ 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 commitme