Senior Medical Director, PVRM

Sumitomo Pharma America, Inc.

Senior Medical Director overseeing medical safety aspects of clinical trials at Sumitomo Pharma. Responsible for safety data analysis, regulatory submissions, and cross-functional collaboration.

Posted 6/12/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $288,200 - $360,200 per yearWebsite

About the role

Key responsibilities & impact

Lead safety strategy and key messaging in NDA/BLA/MAA submissions
Lead ongoing safety monitoring of assigned investigational and marketed products
Providing PVRM Medical representation on product specific and/or clinical study team meetings and governance committees
Prepare and present safety data analysis to project teams and senior management, for assigned products
Evaluate safety data and contribute/author safety sections as a medical safety subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), and Investigator’s Brochures (IB)
Contribute to preparation and update of Company Core Data Sheets (CCDS), Locally labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics (SmPC), Canadian Product Monograph (PM), and Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS)
Medical review of Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports)
Handle Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries
Perform aggregate safety data review in support of signal and trend detection activities, safety evaluation/analysis/investigation, risk benefit management and other departmental activities as appropriate
Participate/contribute to other activities such as literature evaluation, investigator site training, continuing education for internal staff, audits, and inspections
Develop and maintain strong relationship with cross-functional teams such as Clinical Development, pre-clinical Safety, Clinical Operations and Clinical Pharmacology
Maintain a working knowledge of applicable global regulatory authority regulations
Support PVRM or cross-functional ad-hoc projects or assignments that require safety input
Ensure compliance with regulations/internal SOPs and fosters a culture of “Patient first” in line with SMPA’s values and related behaviors
Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements

Requirements

What you’ll need

Medical Degree (MD)
12+ years of relevant experience in biotech or pharmaceutical industry
Experience in Oncology and Neurology is preferred
Experience with NDA/BLA/MAA submission
Prior people management experience

Benefits

Comp & perks

merit-based salary increases
short incentive plan participation
eligibility for our 401(k) plan
medical, dental, vision, life and disability insurances
flexible paid time off
11 paid holidays
additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

safety data analysissafety monitoringmedical safety subject matter expertaggregate safety data reviewrisk management plansadverse event codingcausality statementsNDA submissionBLA submissionMAA submission

Soft Skills

leadershipcommunicationrelationship buildingcollaborationorganizational skillspresentation skillsteamworkproblem-solvingtrainingcompliance

Certifications

Medical Degree (MD)