Director, ReveMate and PPP at Bristol-Myers Squibb

Kariya-shi, Aichi, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Strategic leadership in managing RevMate Pregnancy Prevention program (PPP) for IMiD products and designing/implementing PPP for future assets
Membership in Patient Safety Japan (PSJ) Leadership Team, driving organizational change and team development
Strong cross-functional partnerships and representation of PSJ across the organization
Ability to lead a team of several members and manage vendors for PPP execution
Expertise in pharmacovigilance, risk minimization, regulatory compliance with MHLW/PMDA
Effective communication and collaboration with internal (e.g., Soseli, Anseki, Brand team, Compliance, Legal) and external stakeholders (e.g., 3rd party evaluation committee, MHLW, HCPs, patients)

Responsibilities

Ensure benefit-risk balance across product lifecycle by executing MHLW-agreed safety measures
Oversee end-to-end operations of RevMate for post-marketing IMiD products and future PPPs, ensuring structure, performance, and efficiency
Ensure required revisions of RevMate at appropriate timings
Ensure RevMate activities comply with requirements, including implementation of required education
Supervise required audits and activities of on-site workers for RevMate compliance
Ensure operation of RevMate steering committee
Manage effective communication with internal stakeholders (e.g., Soseli, Anseki, Brand team, Compliance, Legal)
Manage appropriate communications with external organizations (e.g., 3rd party evaluation committee, MHLW)
Develop PPP documents for clinical studies
Support clinical study teams from a safety perspective
Train staff on product safety profile and risk minimization measures
Lead cross-functional teams

Skills

Key technologies and capabilities for this role

PharmacovigilancePharmaco-epidemiologyRisk ManagementBenefit-Risk AssessmentRegulatory CompliancePregnancy Prevention ProgramStrategic LeadershipPatient Safety

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What are the key responsibilities of this role?

The role involves strategic leadership in managing the RevMate Pregnancy Prevention program for IMiD products, leading a team and vendors, designing future PPPs, and collaborating with stakeholders for regulatory compliance.

What is the company culture like at Bristol Myers Squibb?

The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and emphasis on balance and flexibility.

What makes a strong candidate for this Director position?

Strong candidates will have experience in pharmacovigilance, strategic leadership in risk minimization programs like PPP, team leadership, vendor management, and cross-functional collaboration in a regulatory environment.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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