Scientific Associate Director - Safety Pharmacology
BioSpace
Scientific Associate Director Safety Pharmacology 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. 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. Act as a 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. 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). Basic Qualifications Doctorate degree [and relevant post-doc where applicable] and 4 years of relevant scientific experience. Masters degree and 7 years of relevant scientific experience. Bachelors degree and 9 years of relevant scientific experience. Preferred Qualifications 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. Salary and Compensation The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a total rewards plan based on eligibility, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan. Stock-based long-term incentives. Award-winning time-off plans. Flexible work models where possible. Refer to the work location type in the job posting to see if this applies. Equal Opportunity and Accommodations Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr BioSpace
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