Director, Head Of Medical Review Immuno-Oncology

Working with Us
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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 certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Position Summary / Objective

The TA Head – Medical Safety Review provides leadership for Medical Safety Review Physicians (MRSPs) and oversight for vendor activities regarding Medical Review (MR) of all products within the assigned therapeutic area (TA). Provides MR expertise and makes informed MR decisions in cross-functional meetings on critical ICSRs from the TA in order to protect patients, BMS products, and BMS regulatory compliance.

Position Responsibilities

Strategic:Drives continuous improvement and transformation of PV Operations into a highly automated, efficient organization dedicated to achieving industry-leading quality, compliance, and cost effectiveness. Collaborates to build Medical Review capabilities in all global PVOpS sites. Drives change-management in Medical Review regarding process innovation. Creates strategy and provides oversight of single case processing vendor re: medical review for TA products.

Management:Manages and develops the Medical Review Safety Physicians (MRSPs) within the therapeutic area. Provides training and acts as mentor to Medical Review Safety Physicians. Takes the lead in assuring consistent application of work practices and processes. Delegates to and develops MRSPs to ensure talent retention and succession planning.

Medical Review:Subject Matter Expert (SME) for products within the assigned TA, provides medical review oversight of ICSRs. Leads Case Processing & Review Meetings for TA. Oversees execution of RMP re: ICSR-related PV activities. Involved in HA-commitment review and execution pertaining to ICSR assessment and reporting. For products within the assigned TA, ensures high quality medical assessment of ICSRs with particular attention to critical cases (SUSARs, AEs of Interest, potential Drug-Induced Liver Injury [pDILI], pregnancy, any critical events). Provides final decision when needed on seriousness, causality and expectedness assessment and determines regulatory reportability of ICSRs. Provides input the development of the Reference Safety Information section of the Investigator's Brochure; provides peer review as needed for safety documents (RMP, IB, aggregate reports, labels for marketed products).

Compliance:Ensures MRSPs meet/exceed expectations for compliance, quality, regulatory and safety initiatives. Leads all quality monitoring efforts related to TA product knowledge and medical assessment. Collaborates with PV Operational Excellence and CQL Teams to ensure consistency of work practices and SOPs. Supports audits and health authority inspections representing Medical Review. Applies BMS operating philosophy and operate within company policies and procedures and appropriate regulations.

Collaboration:Partners with WWPS personnel at similar leadership level (Case Management Leads, PV Scientist Leads, and SMT Chairs, MSA TA Heads) and personnel from other functions and external stakeholders. Serves as the medical review SME of assigned TA on cross-functional teams. Contributes to the evaluation the safety profile of BMS compounds within the therapeutic area of responsibility. Ad hoc member of SMT. Identifies potential safety signals from individual case reports and informs the appropriate SMT Chair / MSA TA Head of all potentially important cases and issues. Leads Medical Review vendor quality monitoring, training and oversight for the therapeutic area.

Development/Processes:Deals with safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions. Influences and impacts others through clear reasoned argument, helps to drive consensus, and catalyzes action to meet critical regulatory objectives. Represents MR within areas of responsibility, competence and experience. Identifies process improvement and automation opportunities and ensures that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and safety in accordance with company cost effectiveness goals.

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Degree / Experience Requirements
Education required: MD or Equivalent. Board certification and medical specialty relevant to the assigned TA 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 of which at least 3 years were dedicated to medical evaluation and operational pharmacovigilance.

Management experience strongly preferred.

Key Competency Requirements
Knowledgeable and skilled in medicine and pharmaceutical product safety.

Knowledgeable of ICH Guidelines and relevant US and EU PV and GCP regulations. Able to interpret regulations and create new processes as needed.

Experience applying medical knowledge to the interpretation of individual case review; strong skills in differential medical diagnosis.

Previous experience in patient safety / pharmacovigilance.

Experience with reporting of individual adverse events.

Experienced in using MedDRA and WHODrug.

Experience working in a team environment, including supporting other team members when necessary; promoting collegiality and teamwork among peers.

People management experience preferred.

Ability to think clearly and decisively and present independent, reasoned solutions to identified safety issues, support to drive consensus of opinion, and to catalyze action to meet critical regulatory objectives.

Demonstrated problem solving skills that enact change and drive continuous improvement.

Seeks to develop self and others. Aligns objectives with organizational goal.

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.

Ability to build and manage interrelationships by motivating and inspiring others.

Ability to operate autonomously.

Experience with a major safety database (e.g. Oracle ARGUS or ArisG).

Travel: <10%

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 an inclusive culture, promoting diversity 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 a diverse 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.

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

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