Counsel, Drug Development

Bristol Myers Squibb•Princeton, NJ

11d•Hybrid

About The Position

Bristol Myers Squibb is seeking a Counsel, Drug Development to support the Drug Development team. This role involves assisting with the design and execution of clinical trials, and preparing submissions to health authorities for the approval of BMS clinical trials and drugs globally. The position requires reviewing documents for submission to health authorities, including responses to information requests from agencies like the FDA, EMA, and TGA. The Counsel will collaborate with various teams to ensure early identification, prioritization, escalation, and resolution of Drug Development issues. A key aspect of the role is providing proactive, strategic legal and regulatory advice on clinical trial design, execution, and data generation. The Counsel will also serve as the legal point of contact for the Asia Pacific region, assisting regional market lawyers with drug development legal matters. Additionally, the role involves providing comprehensive legal advice on issues such as 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.
Must have five (5) years of experience with/in the following: Conducting risk assessments, documentation, and mitigation processes to advise on clinical trial design.
Must have five (5) years of experience with/in the following: 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.
Must have three (3) years of experience with/in the following: Drafting, reviewing, and negotiating clinical trial contracts.

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.
Assist regional market lawyers on drug development legal issues.
Provide comprehensive legal advice, including issues relating to sponsorship and clinical trial contracting.

Benefits

annual discretionary bonus
healthcare
leave benefits
retirement benefits
Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
unlimited paid sick time
up to 2 paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
an annual Global Shutdown between Christmas and New Years Day.