Scientific Associate Director - Safety Pharmacology

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At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Let’s do this. Let’s change the world. The Scientific Associate Director will lead safety pharmacology lab-based activities within the Safety Pharmacology Sciences team and contribute directly to the success of Translational Safety & Risk Sciences (TSRS), the department responsible for nonclinical safety evaluation within Amgen Research. This role reports to the Senior Director of Safety Pharmacology Sciences.

This leadership role has multiple components: management of in vitro cardiac safety and electrophysiology laboratory and staff; lead and coordinate safety issue resolution studies (in vitro; in vivo); serve as a Safety Pharmacology Subject Matter Expert (SME) on project teams; and contribute to external scientific initiatives. The role requires integration of data across multiple assay systems and modalities to support candidate selection, risk assessment, clinical translation, regulatory strategy, and advancement of industry best practices.

Key Responsibilities

• Oversee the cardiac safety and electrophysiology laboratory, a core function responsible for ion channel, hiPSC-derived cardiomyocyte, and isolated heart assays.
• Manage exploratory and GLP-compliant studies, including outsourcing, protocol development, data review, and report finalization.
• Supervise scientific staff, promote their development and ensure high-quality timely data generation, study tracking, QC, reporting and stakeholder communication
• Maintain compliance with data integrity, safety, and environmental standards.
• Interface with internal & external partners to establish qualified NAMs models for safety assessment.

• Provide expertise to support discovery and development programs and partner with TSRS project team representative (PTR) and other team members (PKDM, pathology, etc) to ensure aligned and efficient execution of safety strategies
• Ensure appropriate evaluation of target- and off target-based safety risks for diverse drug modalities in accordance with evolving ICH guidelines (S7A, S7B/E14, etc.).
• Guide study design, data interpretation, and next-step recommendations to support both lead optimization and clinical candidate selection and contribute to regulatory filings or inquiries.
• Provide oversight of safety pharmacology strategy across modalities, including small molecules, biologics, and emerging therapeutic approaches
• Coordinate investigative studies (e.g. human primary tissue acquisition, functional studies, etc.) and partner with internal and external (CRO) labs to execute.
• Collaborate with relevant experts to evaluate and integrate in vitro and in silico approaches.

• Build and maintain…