Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

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. 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.

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, and 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, and industry codes
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

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, and 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
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
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
Minimal travel; average travel for this position is 5% with some variation based upon the demands of the business imperatives.

Skills

FDA regulatory frameworks
Pharmaceutical commercialization
Clinical development
Medical Affairs
Contracts
Transactions
Strategic collaborations
Licensing arrangements
Biotechnology legal landscape
FDA regulations
Healthcare fraud and abuse laws
Clinical trial regulations
Data privacy
Data governance
Commercialization
Market access issues
Drafting
Negotiation
Communication
Risk management
Executive presence
Relationship-building
Influencing
Analytical skills
Problem-solving
Integrity
Ethical leadership
Microsoft Office Suite
Interpersonal skills
Written communication
Oral communication
Presentation skills
Prioritization
Multi-tasking
Organizational skills
Attention to detail
Confidentiality
Data mining
Data extraction
Working with senior management
Working through uncertainty

Location

NYC office

Work Type

Hybrid

Experience Level

Senior Director
12+ years of legal experience

Education Level

Juris Doctor (J.D.) degree
Active membership in good standing with at least one U.S. state bar

Salary/Compensations

$300,000 - $305,000

Benefits

Incentive bonus
Equity compensation
Matching 401(k)
Medical
Dental
Vision
Commuter benefits
Fertility benefits
Flexible working hours/schedules
Generous Paid Holidays
Unlimited PTO

About the Company

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.

Equal Opportunity

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.