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Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent's global biologics network and Wisconsin's growing life sciences ecosystem. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization.

Catalent Pharma Solutions, Inc.

Lead - Biomanufacturing Compliance - Investigator, Deviations

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Catalent Inc

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Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization.

Catalent

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Associate Lead I - Biomanufacturing Compliance, Lead Investigator

The Director of Medical Evidence Generation in Medical Affairs will lead the strategic development and execution of a robust evidence generation plan for an important asset within the Oncology portfolio, focused primarily in gastrointestinal (GI) and genitourinary (GU) cancers, including Clinical Research Collaborations (CRCs), Medical Affairs Sponsored Trials (MAST), and Investigator-Sponsored Research Studies (ISRs), designed to: Uncover new clinical development opportunities that will maximize the benefit our medicines can bring to patients. Responsibilities will include, but are not limited to, the following: Define and drive the integrated evidence generation strategy aligned with Medical Affairs and overall product strategy, spanning clinical trials (Phase II/IV), real-world evidence (RWE), non-interventional studies, registries, observational research, and health outcomes studies.

YEAR

Bristol Myers Squibb

Director, Global Medical Evidence Generation Lead, Oncology

Review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]). PS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.

Senior Director, Medical Safety Assessment Program Lead, Neuroscience

Support indication and ecosystem readiness by identifying specialty-specific barriers to future adoption, referral pathways, multidisciplinary care needs, patient identification considerations, institutional capability gaps, and opportunities to improve clinical practice excellence. Partner closely with Clinical Development, Translational Medicine, Regulatory, Commercial, HEOR, Market Access, Field Medical, regional medical teams, and other cross-functional stakeholders to support evidence generation, lifecycle planning, governance milestones, and indication readiness.

Senior Director, Worldwide Cell Therapy Autoimmune Medical Affairs, Neurology/Lcm

The Director of Medical Evidence Generation in Medical Affairs, will lead strategy, development, and execution of robust evidence generation strategies for the Cardiovascular (CV) portfolio through Clinical Research Collaborations (CRCs), Medical Affairs Sponsored Studies (MAST), and Investigator-Sponsored Research Studies (ISRs), designed to inform clinical development, support product value, and underpin medical strategy across the product lifecycle. This will be a scientific and strategic leader collaborating across internal functions (Medical Strategy, RWE/Epidemiology, Clinical Operations, Regulatory, HEOR, Access & Value) and with external stakeholders including key opinion leaders (KOLs), academic partners, and data collaborators.

Director, MEG Lead Cardiovascular, Medical Evidence Generation

Responsible for creation and update of the EDSR to proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS). Key partner and strategic advisor to Medical Safety Assessment Physician (MSAP)/Safety Management Team (SMT) Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence to influence decision-making for assets in development and marketed products by evaluating and mitigating risks.

Associate Director, Patient Safety Scientist

Cross-Functional and Global Collaboration: Partner across US and Global Medical, Commercial, Clinical Development, Regulatory, Market Access, Pharmacovigilance, Statistics, Translational Research, Manufacturing and Quality, Project Leadership, and Field Medical to align priorities and advance the US lymphoma medical strategy. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Security Investigator Jobs in Madison, WI

Lead - Biomanufacturing Compliance - Investigator, Deviations Catalent Pharma Solutions, Inc.

Lead - Biomanufacturing Compliance - Investigator, Deviations Catalent Inc

Lead - Biomanufacturing Compliance - Investigator, Deviations Catalent

Associate Lead I - Biomanufacturing Compliance, Lead Investigator Catalent Pharma Solutions, Inc.

Associate Lead I - Biomanufacturing Compliance, Lead Investigator Catalent

Associate Lead I - Biomanufacturing Compliance, Lead Investigator Catalent Inc

Director, Global Medical Evidence Generation Lead, Oncology Bristol Myers Squibb

Senior Director, Medical Safety Assessment Program Lead, Neuroscience Bristol Myers Squibb

Senior Director, Worldwide Cell Therapy Autoimmune Medical Affairs, Neurology/Lcm Bristol Myers Squibb

Director, MEG Lead Cardiovascular, Medical Evidence Generation Bristol Myers Squibb

Associate Director, Patient Safety Scientist Bristol Myers Squibb

Senior Director, US Medical Affairs, Lymphoma Bristol Myers Squibb

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