Counsel, Drug Development

Bristol Myers Squibb; Princeton (NJ); On-site; USD 253,748 - 299,460; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being and Protection

Annual discretionary bonus

Job summary

Bristol Myers Squibb in Lawrenceville, NJ, is seeking a Counsel, Drug Development to join our global team. You will support design and execution of clinical trials and regulatory submissions, review documents for health authorities, and collaborate with cross‑functional partners to manage risk and drive compliant drug development.

The role requires a J.D. or foreign equivalent with licensing and several years in pharmaceutical regulatory law, with experience drafting and negotiating clinical

Qualifications

• J.D., LL.M., or foreign equivalent degree plus five years of related legal experience.
• Active license to practice law in at least one jurisdiction.
• Five years of experience in pharma regulatory law, global clinical trials, drug development, and health authority submissions.
• Three years in pharma/biotech/medical device and drafting, reviewing, and negotiating clinical trial contracts.

Responsibilities

• Support Drug Development team with the design and execution of clinical trials and health authority submissions.
• Review documents submitted to health authorities (FDA, EMA, TGA, etc.).
• Collaborate with teams to identify, prioritize, escalate, and resolve drug development issues.
• Provide proactive legal/regulatory advice on trial design and data generation.
• Act as legal point of contact for the Asia Pacific region.
• Assist regional market lawyers on drug development issues.
• Provide comprehensive legal advice on sponsorship and clinical trial contracting.
• Up to 10% telecommuting.

Skills

Legal expertise

Regulatory affairs

Clinical trial understanding

Contract negotiation

Education

J.D./LL.M. or foreign equivalent

Job description

Working with Us

Challenging. Meaningful. Life-changing. Those aren\'t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You\'ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Employer: Bristol-Myers Squibb Company

Job Title: Counsel, Drug Development

Location: 3401 Princeton Pike, Lawrenceville, NJ 08648

Wage Range: $253,748.00- $299,460.00

Bristol-Myers Squibb Company is hiring a(n) Counsel, Drug Development (in Lawrenceville, NJ).

Duties

• 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.
• Up to 10% telecommuting permitted.

Requirement

• 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; and
• 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; and
• Drafting, reviewing, and negotiating clinical trial contracts.

Additionally, employees are eligible for an annual discretionary bonus, and benefits including healthcare, leave benefits, and retirement benefits. BMS operates a pay-for-performance compensation philosophy and your total compensation may vary based on role, location, and firm, department and individual performance.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment.

• 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.

Work-life benefits include

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

Based on eligibility*, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Eligibility Disclosure

Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients’ lives through science" , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1603202 : Counsel, Drug Development