Senior Director, Assistant General Counsel
$300,000–$305,000 year
RemoteNew York, United States
Job Summary
Advise R&D, Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, and corporate functions on legal, regulatory, and business matters impacting the oncology and rare disease portfolio. Counsel stakeholders on clinical trial activities, investigator-sponsored studies, expanded access programs, and patient support initiatives while reviewing and negotiating agreements with CROs, vendors, and academic partners. Partner with Regulatory Affairs and Quality teams regarding FDA, EMA, and global regulatory requirements, including product development, labeling, and promotional review. Support licensing, collaboration, co-development, and commercial partnership transactions, leading negotiations for complex strategic agreements and due diligence. Draft, review, and negotiate a broad range of commercial and operational agreements while managing outside counsel and legal spend. Conduct legal risk assessments, support investigations and audits, and deliver training on compliance obligations including the Anti-Kickback Statute, False Claims Act, and HIPAA. Advise on data privacy, cybersecurity, and cross-border data transfer issues affecting clinical and corporate operations. Report to the Chief Legal and Compliance Officer, with a requirement to come into the NYC office once a week.
Required 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
- Must be able to come into the NYC office once a week
- 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
- Must be proficient in Microsoft Office Suite
- Must be a member of NY or another state Bar
- 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
- Must be able to effectively lead and coach others
- Must be able to lift 50 lbs
Desired Qualifications
- Demonstrated experience supporting oncology, rare disease, specialty pharmaceutical, or advanced therapy programs preferred
- 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
- 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
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