Counsel, Drug Development

About the role

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.

Responsibilities

• 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.
• Must have three (3) years of experience with/in the following:
  • Working in a pharmaceutical, biotech, or medical device company;
  • Drafting, reviewing, and negotiating clinical trial contracts.

Benefits

• Health Coverage Medical, pharmacy, dental, and vision care.
• Wellbeing Support Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Pay

$253,748.00 - $299,460.00

Schedule

Up to 10% telecommuting permitted.