22 часа назад
Senior Director, Assistant General Counsel (Biotechnology)
300 000 - 305 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Assistant General Counsel (Biotechnology): Advising clinical, regulatory, commercial, medical affairs, and corporate functions on legal and compliance matters supporting oncology and rare disease therapeutics, with an accent on FDA-regulated activities, clinical development, transactions, commercialization, and healthcare compliance. Focus on negotiating strategic agreements, managing regulatory and privacy risks, and balancing complex legal issues with business objectives in a highly regulated biotechnology environment.
Location: New York, NY, with remote work and required attendance at the NYC office once a week
Salary: $300,000–$305,000 annually, plus incentive bonus, equity compensation, and benefits.
Company
is a clinical-stage biotechnology company developing transformative therapies for cancer and rare diseases, including TARA-002 and IV Choline Chloride.
What you will do
- Advise senior leadership and cross-functional teams on legal, regulatory, business, and compliance matters affecting oncology and rare disease programs.
- Support clinical development, investigator-sponsored studies, expanded access programs, research collaborations, CRO relationships, data sharing, and global clinical trials.
- Partner with Regulatory Affairs and Quality on FDA, EMA, and other regulatory requirements, product labeling, promotional review, medical communications, inspections, and enforcement matters.
- Advise Commercial, Market Access, and Medical Affairs on promotional materials, pricing, reimbursement, patient support programs, healthcare professional interactions, publications, and advisory boards.
- Lead negotiation and drafting of licensing, collaboration, co-development, supply, manufacturing, commercial partnership, M&A, and other strategic agreements.
- Manage legal operations, outside counsel, contracting processes, privacy programs, data governance, cybersecurity matters, and legal risk assessments.
Requirements
- Juris Doctor degree from an accredited law school and active membership in good standing with the NY or another U.S. state bar.
- At least 12 years of legal experience, including significant in-house experience in biotechnology, pharmaceuticals, life sciences, or healthcare.
- Strong knowledge of FDA regulations, clinical trial requirements, healthcare fraud and abuse laws, pharmaceutical commercialization, market access, and data privacy.
- Significant experience with contracts, strategic collaborations, licensing arrangements, clinical development, and Medical Affairs support.
- Exceptional drafting, negotiation, communication, analytical, and problem-solving skills, with the ability to manage complex matters independently.
- Proficiency in Microsoft Office Suite, data mining and data extraction, confidential information handling, and presentation to senior management.
Nice to have
- Experience with oncology, hematology, cell and gene therapy, rare disease, or orphan drug programs.
- Experience launching and commercializing specialty therapeutics.
- Experience supporting global or publicly traded biotechnology organizations.
- Familiarity with international regulatory and compliance frameworks.
- Prior law firm experience.
Culture & Benefits
- Team-oriented culture valuing diverse perspectives, collaboration, integrity, and innovation.
- Flexible working hours and schedules.
- Generous paid holidays and unlimited PTO.
- Medical, dental, vision, commuter, fertility, and matching 401(k) benefits.
- Incentive bonus and equity compensation.
- Minimal travel, averaging approximately 5%.
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