What are the responsibilities and job description for the Legal Director/Associate General Counsel position at Latigo Bio?
Reporting to the CFO, Latigo is seeking a Legal Director/Associate General Counsel to oversee legal operations in our fast-paced environment. This role requires deep expertise in contracts, regulations, intellectual property, compliance, and commercial transactions to support our research, development, and commercialization efforts. The ideal candidate will provide strategic legal guidance while ensuring compliance with FDA, EMA, and other global regulatory bodies.
Primary Responsibilities:
Contracts & Transactions
- Draft, review, and negotiate licensing, collaboration, research, and distribution agreements.
- Structure and manage partnerships, joint ventures, and other business transactions.
- Oversee contracts with CROs and CMOs.
Regulatory & Compliance
- Support compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) standards.
- Ensure compliance with FDA, EMA, FTC, HIPAA, GDPR, and other global healthcare regulations.
- Advise on clinical trials, drug development, and product approval processes, including IND, NDA, and BLA submissions.
Intellectual Property & Licensing
- Collaborate with IP counsel to protect patents, trademarks, copyrights, and trade secrets. Manage technology transfers, IP licensing agreements, and patent disputes.
- Risk & Litigation Management:
- Identify and mitigate legal risks related to product liability, clinical trials, and regulatory enforcement.
- Handle litigation, investigations, and dispute resolution in collaboration with external counsel.
Corporate & Commercial Support
- Advise leadership on corporate governance, securities, and public disclosures.
- Support market access, pricing strategies, and interactions with healthcare professionals.
- Ensure compliance with anti-kickback laws, fraud and abuse laws, and industry codes (e.g., PhRMA Code, AdvaMed).
Qualifications and Requirements:
- Juris Doctor (JD) degree from an accredited law school.
- 10 years of legal experience, preferably in biotech, pharmaceuticals, or life sciences.
- Deep understanding of FDA/EMA regulatory frameworks, intellectual property, and commercial transactions.
- Experience in contract negotiation, M&A, and corporate governance within the life sciences sector.
- Strong ability to assess legal risks, advise on business decisions, and interact with regulatory agencies.
- Excellent leadership, communication, and problem-solving skills.
Location:
This position can be located in Thousand Oaks, CA or the San Francisco Bay Area
Salary : $225,000 - $255,000
