Associate Director, R&D Legal Operations

POSITION ID: ADR&D 1412
CATEGORY:
PRACTICE AREA: ,
LOCATION: New York

Global publicly traded pharmaceutical company in New York is seeking an experienced attorney for the position Associate Director, R&D Legal Operations. You will provide legal support to the Research and Global Development teams supporting the company’s robust drug pipeline. You will be responsible for providing advice and counsel on a wide range of legal and regulatory issues related to drug discovery and development. The attorney will serve as a proactive, solutions-oriented ethical counselor to internal teams.

As an R&D Attorney, a typical day may include:

  • Provides advice and counsel to teams accountable for clinical studies across the Hematology therapeutic area
  • Partner with Regulatory and Global Patient Safety teams to ensure compliance with laws and regulations
  • Provide legal support to teams handling GCP non-compliance investigations
  • Serve as a subject matter authority on R&D matters within the Law Department and collaborate with other legal functions (e.g., Business Development and Contracting, Compliance, Litigation and Products/Regulatory Law group)
  • Conduct training to client groups on a variety of legal and regulatory issues

This role may be for you if you have:

  • Experience with regulations and laws impacting the Research and Development departments within the biopharmaceutical industry. These include ICH GCP, US FDA regulations relating to clinical trials, GDPR and other privacy laws
  • Working knowledge and understanding of the Food, Drug & Cosmetic Act, Anti-Kickback statute, Foreign Corrupt Practices Act a plus
  • Proficient in drafting and negotiation of Clinical Trial Agreements and Informed Consent Forms
  • Understanding of biopharmaceutical industry trends, legislative initiatives and impact on the company
  • Strong interpersonal skills, including diplomacy and flexibility, and the ability to communicate effectively with personnel at all levels
  • Good judgment and ability to maintain an objective perspective, particularly when determining the legal risk of clinical matters
  • Ability to work well independently and on a team and can prioritize multiple matters
  • Resilience and patience while supporting a complex growing clinical business

To be considered for this position you must posses BA/BS and JD with excellent law school credentials. Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel with 5+ years experience. In-house biotech/pharmaceutical experience a significant plus.

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