Counsel, Drug Development

About the role

Bristol Myers Squibb is seeking a Counsel, Drug Development to join our team in Lawrenceville, NJ. This role supports the Drug Development team in designing, executing clinical trials, and submitting to health authorities for the approval of BMS clinical trials and drugs worldwide.

Responsibilities

• Support Drug Development team with the design, execution of clinical trials, and the submissions to health authorities for the approval of BMS clinical trials and drugs around the world.
• Review documents to be submitted to health authorities, including responses to information requests by health authorities around the world, including FDA, EMA, TGA, etc.
• Collaborate with various teams to ensure early identification, prioritization, timely escalation, and resolution of the relevant Drug Development issues.
• Provide proactive, strategic legal, regulatory advice regarding design and execution of clinical trials, and generation of clinical trial data.
• Act as legal point of contact for the Asia Pacific region.
• Aid regional market lawyers on drug development legal issues.
• Provide comprehensive legal advice, including issues relating to sponsorship and clinical trial contracting.

Requirements

• Requires J.D., LLM, or foreign equivalent degree plus five (5) years of related legal experience.
• Must have active license to practice law in at least one jurisdiction.
• Must have five (5) years of experience with/in the following:
• Knowledge in Pharmaceutical regulatory law, global clinical trials, drug development, and health authority submissions;
• Conducting risk assessments, documentation, and mitigation processes to advise on clinical trial design;
• Leveraging knowledge of emerging legal and industry issues and trends to inform advice and address potential legal risk.

Qualifications

Not specified.

Skills

Not specified.

Benefits

Not specified.

Pay

$253,748.00 - $299,460.00

Schedule

Not specified.