Senior Director – Counsel, Clinical Development, Regulatory Legal

📋 Description

• Deliver strategic, solutions-focused legal advice and expertise in regulatory matters and Good Clinical Practice (GCP) to support Lilly’s clinical development initiatives.

• Act as the main legal partner for the Clinical Trials Capabilities team.

• Assist in AI and automation projects throughout clinical development and clinical trial operations.

• Provide counsel on legal, regulatory, and GCP compliance regarding R&D Quality issues.

• Stay informed about the changing global expectations and emerging laws, regulations, and guidance related to clinical trials.

• Influence both internal and external partners on key regulatory policy initiatives.

⛳️ Requirements

• Bachelor’s Degree and a Doctor of Jurisprudence (J.D.).

• Must be licensed to practice law in one of the 50 states in the USA.

• A minimum of 5-10 years of experience as an in-house attorney in either a law firm or industry (pharmaceutical or device).

• A highly motivated and collaborative team member with excellent communication skills.

• Strong judgment and a high level of attention to detail.

• Outstanding written and verbal communication skills with the ability to influence others.

• Proven capability to handle highly confidential information appropriately.

• Demonstrated commitment to expanding knowledge and adapting to a fast-paced, changing environment.

• Proven leadership and efficiency in collaborating with senior management.

• Previous experience with regulatory agencies.

🏝️ Benefits

• Comprehensive benefits program.

• Eligibility to participate in a company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Eligibility for medical, dental, vision, and prescription drug coverage.

• Flexible benefits options (e.g., healthcare and/or dependent daycare flexible spending accounts).

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).