Senior Director, Assistant General Counsel

Protara Therapeutics; New York (NY); Hybrid; USD 300,000 - 305,000; Full time

Benefits offered by this job

Incentive bonus

Equity compensation

401(k) matching

Medical

Dental

Vision

Commuter benefits

Fertility benefits

Job summary

Protara Therapeutics seeks a Senior Director, Assistant General Counsel to serve as a strategic legal leader supporting TARA-002 and IV Choline Chloride programs. The role partners with R&D, Clinical Development, Medical Affairs, Regulatory, Commercial, Market Access, and corporate functions to enable business objectives while managing compliance risks in a regulated biotech environment.

This senior in-house attorney will oversee complex strategic transactions, licensing, sponsored research,

Qualifications

• J.D. from an accredited law school.
• Active U.S. state bar in good standing.
• 12+ years legal experience, including significant in-house experience in biotech/pharma or healthcare.

Responsibilities

• Serve as strategic legal counsel to senior leadership on oncology and rare disease initiatives.
• Provide legal guidance on clinical development, regulatory affairs, and product commercialization.
• Lead complex transactions including collaborations, licensing, and strategic partnerships.
• Support clinical trials, CROs, and vendor agreements; oversee data sharing and real-world evidence initiatives.
• Ensure compliance with FDA, HIPAA, Sunshine Act/Open Payments, and other healthcare laws.

Skills

Strategic leadership

FDA regulatory

Biotech experience

In-house counsel

Contracting & negotiations

Licensing & transactions

Cross-functional collaboration

Regulatory affairs

Clinical development support

Education

Juris Doctor (J.D.)

Active state bar membership

Tools

Microsoft Office Suite

Job description

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:
• 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

Privacy & Data Governance

Leadership & Cross-Functional Collaboration

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 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.

The ideal candidate is a pragmatic, business-oriented attorney who thrives in a dynamic biotechnology environment and is passionate about advancing therapies for patients with serious and life-threatening diseases. This individual combines strong legal expertise with strategic thinking, collaboration, and leadership to help the company achieve its scientific, clinical, and commercial objectives while maintaining the highest standards of integrity and compliance.

Computer Skills

• Must be proficient in Microsoft Office Suite.

Certificates, Licenses, Registrations: must be a member of NY or another state Bar.

Physical Demands

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• This position requires minimal travel; average travel for this position is 5% with some variation based upon the demands of the business imperatives.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

No specific work demands.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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

We offer a competitive Compensation & Benefits package including:

• incentive bonus
• equity compensation
• matching 401(k)
• medical
• dental
• vision
• commuter
• fertility benefits

Why You’ll Love Working at Protara

• Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
• Company-wide dedication to profoundly impacting patients’ lives.
• Amazing culture whereby our core values and behaviors are shared cross-functionally.
• Generous Paid Holidays and Unlimited PTO.

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws