Overview
A leading organization in the Pharmaceuticals & Biotech sector is seeking an Associate General Counsel to lead the R&D legal function. This role involves providing strategic legal support to research and development activities, ensuring compliance, managing risk, and collaborating with cross-functional teams. The position offers significant visibility, growth opportunities, and the chance to impact key business outcomes.
Responsibilities
- Provide legal support to R&D teams, ensuring compliance with applicable laws and managing legal risks
- Collaborate with R&D leadership to develop strategies aligned with organizational goals
- Advise on regulatory matters related to clinical trials and product development
- Negotiate and draft agreements related to R&D, including collaborations and clinical trial contracts
- Monitor legal developments in biotechnology and communicate relevant updates to stakeholders
- Lead and mentor a high-performing legal team, promoting collaboration and professional growth
- Prepare and present legal analyses and recommendations to executive leadership
Requirements
- Juris Doctor (J.D.) degree from a U.S. law school and admission to a state bar in good standing
- Minimum of 15 years of legal experience in the biotech or pharmaceutical sectors, including at least 5 years in-house
- Expertise in laws governing human subject research and biotechnology
- Experience with clinical development processes and managing complex research collaborations
- Strong negotiation and strategic communication skills with the ability to influence diverse stakeholders effectively
Preferred Qualifications
- Knowledge of the Federal Food, Drug, and Cosmetic Act
- Familiarity with regulatory compliance and human subject research protection laws
- Experience with regulatory affairs and clinical trial management systems
- Understanding of data privacy regulations and risk management tools
- Proficiency with collaboration and contract management software (e.g., Microsoft Teams, Slack, DocuSign)
- Experience or knowledge related to AI, digital health, and Mandarin language proficiency is a plus
Compensation & Benefits
- Annual salary range: $340,100 – $430,100
- Comprehensive medical, dental, and vision insurance
- 401(k) plan with employer matching
- Generous paid time off and wellness programs
- Life insurance and flexible spending accounts
- Equity opportunities through an employee stock purchase plan
Location
- Remote position
- Candidates must be based in the United States
- No visa sponsorship available