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 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.
Other Skills and Abilities:- 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 are essential
- It is essential that this individual demonstrates the ability to work with highly confidential information.
- Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
- 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.
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.
Work Environment: 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. The requirements listed above are representative of the knowledge, skill, and/or ability required. 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, and fertility benefits.
