Senior Director, R&D Counsel
Our client is a mission-driven, publicly traded biopharmaceutical company focused on developing and commercializing transformative therapies for patients with rare diseases. With an innovative pipeline, a blockbuster product, and a commitment to innovation, the Company is entering an exciting phase of growth and scientific advancement.
Reporting to the General Counsel, the Company is seeking a strategic and experienced Senior Director, R&D Counsel to join the Legal team. This critical role will provide legal support across our research and development functions, including clinical operations, regulatory affairs, and medical affairs. The ideal candidate will be a collaborative, business-minded attorney with deep experience in the life sciences industry and a passion for improving patient outcomes.
Key Responsibilities:
- Serve as the primary legal advisor to R&D teams, including clinical development, regulatory, and medical affairs.
- Develop, implement, and advice on strategy and initiatives relating to R&D and clinical activities.
- Draft and negotiate R&D related agreements, including clinical trial agreements, informed consent forms, and investigator-initiated studies, etc.
- Advise on regulatory matters, including interactions with FDA and other global health authorities.
- Support compliance with applicable laws, regulations, and industry standards (e.g., FDA, EMA, ICH, PhRMA).
- Collaborate cross-functionally with Legal, Compliance, and other departments to ensure alignment and mitigate risk.
- Assist in the development and implementation of policies, training, and procedures related to R&D activities.
- Monitor legal and regulatory developments relevant to clinical research and rare disease drug development.
Qualifications:
- J.D. from an accredited law school and admission to practice law in at least one U.S. jurisdiction.
- Minimum of 12 years of legal experience, with significant in-house or law firm experience supporting biopharma R&D.
- Deep understanding of clinical development, regulatory frameworks, and rare disease drug development.
- Strong interpersonal and communication skills, with the ability to influence and advise senior stakeholders.
- Proven ability to manage complex legal issues in a fast-paced, innovative environment.
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