The role leads defined safety science activities for assigned cell therapy assets, integrating safety data, supporting benefit-risk decisions, and managing patient risks across the product lifecycle.
Compensation
The annual base pay for this position ranges from $132K to $199K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Conduct and coordinate safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets.
Develop MedDRA search strategies with appropriate guidance.
Translate emerging safety data into clear analyses and recommendations for asset teams.
Lead defined components of pharmacovigilance and risk-management planning, including RMPs, REMS, risk-minimization tracking and benefit-risk assessments.
Author and project-manage aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, REMS and ad hoc analyses.
Requirements
Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline
The purpose of the Associate Director Analysis role is to support the design of clinical programs and trials by bringing together internal and external data and information, analyses and insights to drive excellence in clinical trial design.
Responsibilities
Analyze, create visualizations in support of, and communicate data, insights, and recommendations
Create and adapt queries to extract vital data from internal and external data sources
Extract and curate data from multiple data sources to build integrated datasets and visualizations
Partner cross-functionally to ensure consistency, completeness, and robustness in data
Apply novel techniques to add efficiency and automation into Clinical Trial Design
Requirements
Bachelor’s Degree in a scientific, analytic, or health-related field
The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects, including clinical trials, patient safety, and global medical affairs.
Responsibilities
Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects.
Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs.
Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation).
Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management.
Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects.
Provide scientific leadership and technical support to the Executive Director of NAMs across a diverse portfolio of initiatives.
Responsibilities
Assist the Executive Director of NAMs in providing scientific direction, technical review, and execution support across the NAMs portfolio and NAMs Developer Coalition workstreams.
Support NAMs-DC working groups and member activities, including scientific priorities, technology-specific development plans, evidence gaps, milestones, and deliverables.
Provide scientific support for the ARPA-H CATALYST project and participating CATALYST teams, including technical assessment, regulatory science input, advisor engagement, and coordination of scientific deliverables.
Support NCAC initiatives, including the development, scientific review, harmonization, regulatory science input on validation studies, and maintenance of a NAMs Glossary and related terminology or standards activities.
Contribute scientific expertise to collaborative initiatives.
Requirements
PhD
PharmD
MD
or equivalent doctoral degree in a relevant scientific or clinical discipline
Nice to have: experience with NAMs applications in toxicology
A senior scientific leader within the Cell Therapy Patient Safety Unit leading safety science strategy and delivery for complex cell therapy assets, integrating clinical, nonclinical, epidemiologic, and real-world evidence to shape safety profiles.
Compensation
The annual base pay for this position ranges from $203K to $305K.
Responsibilities
Lead safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets
Set the safety science strategy for multiple, complex or high-priority assets and translate emerging data into clear recommendations
Lead proactive pharmacovigilance and risk-management planning, including Global Risk Management Plans, REMS, risk-minimization measures and benefit-risk assessments
Provide strategic leadership and oversight for aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, and REMS
Lead safety content and strategy for protocols, Investigator Brochures, Reference Safety Information, informed consent forms, clinical study reports, and core data sheets
Requirements
Bachelor’s degree in life sciences, pharmacy, nursing or a related discipline
Advanced degree (MSc, PhD, PharmD) preferred in immunology, autoimmune disease, pharmacology, epidemiology or a related discipline
Nice to have: cell therapy safety
Nice to have: immunology cell therapy development
Nice to have: pharmacoepidemiology
Therapeutic Area Lead, Lymphoid & Myeloid Malignancies, Medical Affairs Oncology
Johnson & Johnson Innovative Medicine · Posted Nov 9, 2026
Responsible for monitoring clinical trials, ensuring data integrity, patient safety, and compliance with regulatory standards across multiple sites.
Responsibilities
Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
Maintains submission of expenses according to travel and expense requirements within company guidelines
Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
Plans day-to-day activities for monitoring a clinical study and sets priorities per site
Requirements
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution
Licensed health-care professional (i.e., registered nurse)
Senior leader responsible for strategic, scientific, operational, and people leadership across a portfolio of immunology programs.
Compensation
$255,800.00 - $402,700.00
Responsibilities
Provide strategic oversight for a portfolio of immunology assets across multiple stages of development
Partner with the Immunology Therapeutic Area Head and leaders across Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Drug Safety and Pharmacovigilance, Translational Medicine, and Medical Affairs to drive development strategy execution and delivery of key portfolio milestones
Ensure Clinical Science contributions support development plans, regulatory submissions, health authority interactions, and lifecycle management activities
Apply Clinical Science expertise to inform therapeutic area and portfolio strategy across evolving science, treatment trends, competitive landscape, and regulatory considerations
Optimize allocation of Clinical Science resources and associated budgets across a complex and evolving portfolio to align with business priorities and organizational objectives
The Patient Safety & Pharmacovigilance Specialist is responsible for executing International Adverse Event and pharmacovigilance activities as required by Regulatory Agency regulations, coordinating Adverse Event and pharmacovigilance activities for sites worldwide.
Responsibilities
Monitor the Pharmacovigilance (PV) System through development of monthly performance reports to ensure regulatory compliance and process effectiveness.
Prepare and analyze periodic PV metrics including KPIs, quality incidents, CAPAs, audits, and inspection outcomes.
Compile and trend compliance data, conduct root cause assessments, gap analyses, and evaluate effectiveness of corrective actions.
Evaluate safety reports and study documents for completeness, accuracy, and clinical relevance.
Support audit and inspection readiness, and assist during internal audits and health authority inspections.
Requirements
Bachelor’s degree in a medical, nursing, pharmaceutical, or life sciences discipline
Advanced degree (e.g., BPharm, PharmD, RN, MD, MSc or equivalent)
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