Scientific Associate Director Safety Pharmacology - Thousand Oaks CA

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    "raw": "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.\nKey Responsibilities\n1. Laboratory Leadership & Talant Management\nOversee the cardiac safety and electrophysiology laboratory, a core function responsible for ion channel, hiPSC-derived cardiomyocyte, and isolated heart assays.\nManage exploratory and GLP-compliant studies, including outsourcing, protocol development, data review, and report finalization.\nSupervise scientific staff, promote their development and ensure high-quality timely data generation, study tracking, QC, reporting and stakeholder communication\nMaintain compliance with data integrity, safety, and environmental standards.\nInterface with internal & external partners to establish qualified NAMs models for safety assessment.\n2. Safety Pharmacology Subject Matter Expert (SME) on TSRS Teams\nProvide 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\nEnsure appropriate evaluation of target- and off target-based safety risks for diverse drug modalities in accordance with evolving ICH guidelines (S7A, S7B/E14, etc.).\nGuide study design, data interpretation, and next-step recommendations to support both lead optimization and clinical candidate selection and contribute to regulatory filings",
    "city": "study tracking",
    "region": "QC",
    "country": "Canada",
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      "raw": "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.\nKey Responsibilities\n1. Laboratory Leadership & Talant Management\nOversee the cardiac safety and electrophysiology laboratory, a core function responsible for ion channel, hiPSC-derived cardiomyocyte, and isolated heart assays.\nManage exploratory and GLP-compliant studies, including outsourcing, protocol development, data review, and report finalization.\nSupervise scientific staff, promote their development and ensure high-quality timely data generation, study tracking, QC, reporting and stakeholder communication\nMaintain compliance with data integrity, safety, and environmental standards.\nInterface with internal & external partners to establish qualified NAMs models for safety assessment.\n2. Safety Pharmacology Subject Matter Expert (SME) on TSRS Teams\nProvide 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\nEnsure appropriate evaluation of target- and off target-based safety risks for diverse drug modalities in accordance with evolving ICH guidelines (S7A, S7B/E14, etc.).\nGuide study design, data interpretation, and next-step recommendations to support both lead optimization and clinical candidate selection and contribute to regulatory filings",
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      "Value": "<div>&nbsp;</div><div><b><i>ATTENTION MILITARY AFFILIATED JOB SEEKERS</i></b>&nbsp;- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to&nbsp;<i>Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers</i>. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is \"On-Site\" at the location detailed in the job post.<br>&nbsp;<div>What you will do<br>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 &amp; Risk Sciences (TSRS), the department responsible for nonclinical safety evaluation within Amgen Research. This role reports to the Senior Director of Safety Pharmacology Sciences.<br><br>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.<br><br>Key Responsibilities<br><br>1. Laboratory Leadership &amp; Talant Management&nbsp;<br><br>Oversee the cardiac safety and electrophysiology laboratory, a core function responsible for ion channel, hiPSC-derived cardiomyocyte, and isolated heart assays.<br>Manage exploratory and GLP-compliant studies, including outsourcing, protocol development, data review, and report finalization.<br>Supervise scientific staff, promote their development and ensure high-quality timely data generation, study tracking, QC, reporting and stakeholder communication<br>Maintain compliance with data integrity, safety, and environmental standards.<br>Interface with internal &amp; external partners to establish qualified NAMs models for safety assessment.<br>2. Safety Pharmacology Subject Matter Expert (SME) on TSRS Teams&nbsp;<br><br>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<br>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.).<br>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.<br>Provide oversight of safety pharmacology strategy across modalities, including small molecules, biologics, and emerging therapeutic approaches<br>Coordinate investigative studies (e.g. human primary tissue acquisition, functional studies, etc.) and partner with internal and external (CRO) labs to execute.&nbsp;<br>Collaborate with relevant experts to evaluate and integrate in vitro and in silico approaches.<br>3. External Scientific Influence&nbsp;<br><br>Build and maintain external collaborations with academic, industry, and consortium partners to advance mechanistic safety understanding and safety pharmacology best practices<br>Develop scientific eminence through peer-reviewed publications, presentations, and invited talks<br>Promote adoption of human-relevant in vitro models (e.g., stem cell–derived cardiomyocytes and other NAMs)<br>Contribute to industry thinking on emerging modality-specific safety considerations (e.g., oligonucleotides and novel therapeutics)</div></div><p class=\"MsoNormal\" dir=\"ltr\"><strong><o:p></o:p></strong></p>",
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