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    Director, Head Of Medical Review Immuno-Oncology

    Bristol Myers Squibb
    8 years years
    preferred by company
    10 Nov. 22, 2024
    Job Description
    Job Type: Full Time Education: MD or Equivalent Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description

    Working with Us
    At Bristol Myers Squibb, work is more than a job — it’s a chance to make a meaningful impact. Every day brings opportunities to engage in work that’s challenging, meaningful, and life-changing. From pioneering advancements in cell therapy to optimizing production processes, our work transforms patient lives and the careers of our team members. We provide an environment where you can grow, thrive, and collaborate with diverse, high-performing teams.

    Balance and flexibility are central to our work culture. We offer competitive benefits, services, and programs designed to support our employees in achieving their professional and personal goals. Discover more at careers.bms.com/working-with-us.

    Functional Area Overview
    The Worldwide Patient Safety (WWPS) group is dedicated to ensuring the safety of our medicines. Our responsibilities encompass all aspects of pharmacovigilance and pharmaco-epidemiology, including single-case and aggregate safety monitoring, safety reporting, benefit-risk assessment, risk management strategy and planning, execution of post-marketing commitments, and compliance with global regulatory requirements.

    Position Summary and Objective
    As the Therapeutic Area (TA) Head – Medical Safety Review, you will lead Medical Safety Review Physicians (MSRPs) and oversee vendor activities related to medical review of products within your assigned therapeutic area. You’ll provide expertise, make critical medical review decisions, and ensure patient safety, regulatory compliance, and the integrity of Bristol Myers Squibb (BMS) products.

    Position Responsibilities

    Strategic Responsibilities

    • Lead efforts to transform Pharmacovigilance (PV) Operations into an automated, efficient, and industry-leading function focused on quality, compliance, and cost-effectiveness.
    • Build medical review capabilities across global PV Operations sites.
    • Drive process innovation and manage change within medical review.
    • Create and oversee strategies for single-case processing vendors for TA products.

    Management Responsibilities

    • Develop and mentor Medical Safety Review Physicians (MSRPs) within the TA.
    • Provide training and ensure consistency in medical review practices.
    • Delegate effectively while ensuring talent retention and succession planning.

    Medical Review Responsibilities

    • Act as a Subject Matter Expert (SME) for products in the TA, providing medical oversight for Individual Case Safety Reports (ICSRs).
    • Lead case processing and review meetings for the TA.
    • Ensure high-quality medical assessments of ICSRs, particularly for critical cases (e.g., SUSARs, pDILI, pregnancies, or other significant events).
    • Collaborate on the development of safety documents, including Risk Management Plans (RMPs), Investigator’s Brochures (IBs), and product labels.

    Compliance Responsibilities

    • Ensure compliance with regulatory, quality, and safety standards.
    • Lead quality monitoring efforts for medical assessments within the TA.
    • Represent Medical Review in audits and inspections.
    • Align work practices with global SOPs and BMS operating philosophies.

    Collaboration

    • Partner with cross-functional teams, including PV Scientists, Case Management Leads, and external stakeholders.
    • Serve as a medical review SME on cross-functional teams and contribute to safety evaluations for TA products.
    • Monitor vendor quality, provide training, and ensure effective oversight for TA medical review activities.

    Process Development and Optimization

    • Address safety-related challenges using critical medical and regulatory analyses.
    • Identify process improvement opportunities and promote efficiency while maintaining quality and compliance.

    Education and Experience Requirements

    • Degree: MD or equivalent required. Board certification in a relevant medical specialty is preferred.
    • Experience: At least 7 years of combined relevant experience, including:
      • 2+ years in clinical practice or a related setting.
      • 5+ years in the pharmaceutical industry, with at least 3 years focused on medical evaluation and operational pharmacovigilance.
      • Previous management experience strongly preferred.

    Key Competency Requirements

    • In-depth knowledge of medicine and pharmaceutical product safety.
    • Expertise in ICH Guidelines and US/EU PV and GCP regulations.
    • Strong skills in medical case assessment, including differential diagnosis.
    • Proficient in using safety databases (e.g., Oracle ARGUS or ArisG) and coding systems like MedDRA and WHODrug.
    • Exceptional problem-solving and decision-making skills.
    • Demonstrated ability to build relationships, inspire others, and manage change.
    • Proven ability to operate autonomously while aligning with organizational goals.
    • Excellent written and verbal communication, presentation, and interpersonal skills.

    Additional Information

    • Travel: <10%.
    • If you’re intrigued by this role but feel your qualifications don’t perfectly align, we encourage you to apply. You may be closer to transformative work than you realize.

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