Bristol-Myers Squibb is hiring: Senior Director, Head of Medical Review in Princ
Bristol-Myers Squibb, Princeton, NJ, United States
Senior Director, Head of Medical Review
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 rich in diversity. 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.
Functional Area Description
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines. This includes all pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of safety post-marketing commitments and ensuring compliance with global regulatory requirements.
Position Summary / Objective
The Head of Medical Safety Review provides leadership and direction for a department of up to 80 in-house and vendor-employed Medical Safety Review Physicians and their Therapeutic Area Heads across all PVOpS sites. Develops departmental strategy for best practice in delivering excellence in the Medical Review (MR) of Adverse Event reports for all BMS development and marketed products. Represents MR in the PV Operations and Systems Leadership Team and the WWPS Extended Leadership Team. Provides MR expertise and makes informed MR decisions in cross-functional meetings on most critical ICSRs in order to protect patients, BMS products, and BMS regulatory compliance.
Position Responsibilities
- Strategic: Decides Medical Review strategy with regard to driving continuous improvement and transformation of PV Operations into a highly automated, efficient organization dedicated to achieving industry-leading medical quality, compliance, and cost effectiveness.
- Management: Manages and develops the Therapeutic Area Heads / Directors within Medical Safety Review. Takes the global lead in assuring consistent application of work practices and processes.
- Medical Review: Provides guidance regarding medical review of individual clinical trial and post-marketing reports. Oversees single case processing vendor regarding medical review strategy and structure.
- Compliance: Accountable for compliance relating to complete and timely assessment of ICSRs for all BMS products for submission per local regulatory requirements.
- Process: Ensures high quality approach to medical assessment of ICSRs with particular attention to defining critical cases.
- Collaboration: Partners with WWPS personnel at similar leadership level and executives from other functions and external stakeholders.
- Development/Processes: Deals with safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Experience / Degree Requirements
- Education required: MD or Equivalent. Board certification and medical specialty relevant to BMS product portfolio preferred.
- Minimum of 7 years combined relevant experience, including at least 2 years in clinical practice or relevant setting and at least 5 years of pharmaceutical industry experience including management experience.
Key Competency Requirements
- Knowledgeable and skilled in medicine and pharmaceutical product safety with a track record of working in pharmacovigilance.
- Knowledgeable of ICH Guidelines and relevant US and EU PV and GCP regulations.
- Experience applying medical knowledge to the interpretation of individual case review.
- Working in a global corporate business context.
- Experienced in using MedDRA and WHODrug.
- People management experience mandatory.
- Ability to develop and present independent, reasoned solutions to identified safety issues.
- Demonstrated problem solving skills that enact change and drive continuous improvement.
- Excellent oral and written English skills.
- Excellent communication, presentation, interpersonal and time management skills.
- Demonstrated flexibility, open mindedness, and adaptability in a rapidly changing environment.
- Experience working in a team environment, including supporting other team members when necessary.
- Experience with a major safety database (e.g. Oracle ARGUS or ArisG).
Travel Required: <10%
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.