Scientific Associate Director - Safety Pharmacology

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

Amgen is seeking a Scientific Associate Director for Safety Pharmacology to lead lab-based activities within the Safety Pharmacology Sciences team. This role reports to the Senior Director, TSRS, and involves managing the cardiac safety lab, coordinating studies, and contributing to regulatory strategy.

The leader will oversee staff, ensure data quality, and collaborate with internal and external partners to advance safety strategies across modalities and translational programs.

Responsibilities

• Laboratory leadership and talent management.
• Oversee the cardiac safety and electrophysiology laboratory, coordinating ion channel and hiPSC-derived cardiomyocyte assays.
• Manage exploratory and GLP-compliant studies, including outsourcing, protocol development, data review, and report finalization.
• Supervise scientific staff 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 and external partners to establish NAMs models for safety assessment.
• Serve as Safety Pharmacology SME on TSRS teams; support discovery and development programs.
• Guide study design, data interpretation, and recommendations to support lead optimization and regulatory filings.
• Coordinate investigative studies and collaborate with CROs and internal labs.

Skills

Laboratory leadership

Staff management

Safety pharmacology

Project coordination

Data interpretation

Tools

GLP studies

In vitro assays

Ion channel assays

Job description

Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Scientific Associate Director Safety Pharmacology

What you will do

Lets do this. Lets 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

• Laboratory Leadership & Talant Management
• 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.
• Safety Pharmacology Subject Matter Expert (SME) on TSRS Teams
• 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.
• External Scientific Influence
• Build and maintain external collaborations with academic, industry, and consortium partners to advance mechanistic safety understanding and safety pharmacology best practices
• Develop scientific eminence through peer-reviewed publications, presentations, and invited talks
• Promote adoption of human-relevant in vitro models (e.g., stem cellderived cardiomyocytes and other NAMs)
• Contribute to industry thinking on emerging modality-specific safety considerations (e.g., oligonucleotides and novel therapeutics)

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.