Scientific Associate Director - Safety Pharmacology
Amgen
Summary
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.
Job description
Key Responsibilities
Laboratory Leadership & Talent 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 cell–derived cardiomyocytes and other NAMs).
- Contribute to industry thinking on emerging modality-specific safety considerations (e.g., oligonucleotides and novel therapeutics).
Requirements
- Doctorate degree and 4 years of relevant scientific experience OR Master’s degree and 7 years of relevant scientific experience OR Bachelor’s degree and 9 years of relevant scientific experience
- PhD in Pharmacology, Neuroscience, Physiology, Biomedical Sciences, or related field
- Broad experience in in vitro and or in vivo safety pharmacology across cardiovascular, respiratory and CNS domains
- Working knowledge of cardiac ion channel assays (e.g., hERG, Nav1.5, Cav1.2) and hiPSC-derived cardiomyocyte and isolated heart assays
- Experience managing outsourced studies and CRO relationships
- Experience supporting discovery and development project teams as a safety pharmacology SME or toxicology representative
- Familiarity with GLP-enabling safety pharmacology packages and integration with toxicology studies
- Demonstrated people leadership and laboratory management experience
- Strong cross-functional communication and problem-solving skills
- Track record of scientific publications and participation in external scientific forums or consortia
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life & Disability Insurance
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-Based Long-Term Incentives
- Paid Time Off
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.