Senior Director, Assistant General Counsel

Protara Therapeutics, Inc.•New York, NY

8d•$300,000 - $305,000•Hybrid

About The Position

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.

Requirements

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
Must be proficient in Microsoft Office Suite
Must be a member of NY or another state Bar
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
Demonstrated 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

Nice To Haves

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

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, and biomarker and translational research partnerships
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, and 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 advice 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