Scientific Associate Director – Project Toxicologist

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $194.3k - $262.8k / year

⏰ Full Time

🟠 Senior

👔 Director

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Serve as the key scientific interface between Translational Safety & Risk Sciences and cross-functional project teams from discovery through post-marketing • Serve as TSRS Project Team Representative and lead the TSRS sub-team on core project teams • Develop and implement fit-for-purpose nonclinical safety strategies aligned with regulatory expectations • Adapt safety strategies in response to emerging data and project team needs • Partner with teams developing biotherapeutics, small molecules, targeted protein degraders, RNA-based therapies, and other complex modalities • Coordinate the TSRS sub-team and leverage the TSRS advisory network to inform human risk assessment and development strategy • Design, implement, oversee, and interpret nonclinical safety assessment programs • Develop innovative study designs using AI-enabled approaches and New Approach Methodologies to enhance translational risk assessment • Evaluate experimental data and author sections of nonclinical strategy, governance, and regulatory submissions, including first-in-human applications and marketing authorizations • Communicate with TSRS, project teams, leadership, governance bodies, and regulatory agencies • Balance multiple project teams and stakeholders in a fast-paced, highly matrixed environment • Collaborate with internal scientists and external partners • Contribute to licensing evaluations, due diligence assessments, and external partnerships • Mentor and support fellow scientists in nonclinical studies and development programs

🎯 Requirements

• Doctorate degree (PhD, PharmD, or MD) and 4 years of Toxicology experience, or Master’s degree and 7 years of Toxicology experience, or Bachelor’s degree and 9 years of Toxicology experience • Minimum of 8 years of drug development experience as a Project Toxicologist/Nonclinical Safety Project Team Representative at all stages of development, including late-stage assets and interactions with global regulatory agencies • End-to-end small- and large-molecule safety assessment experience across multiple therapeutic areas and modalities • Preferred experience in nonclinical safety assessment of siRNA therapeutics, antibody-drug conjugates, antibody-peptide conjugates, and/or targeted protein degraders • Proven ability to serve as a cross-functional thought partner and drive alignment across R&D functions • Subject matter expertise in a defined area of toxicology • Experience supporting business development efforts through due diligence evaluations • Scientific leadership with matrixed management experience • Excellent communication and ability to influence diverse partners • External visibility as a toxicology subject matter expert through presentations, publications, and/or participation in external collaborative groups • Board certification by the American Board of Toxicology (preferred qualification)

🏖️ Benefits

• 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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support