Scientific Director developing nonclinical safety strategies at Amgen. Leading multidisciplinary teams in drug development across various therapeutic areas including oncology and immunology.
Responsibilities
Develop and implement a fit-for-purpose nonclinical safety strategy based on a strong scientific foundation
flexibly evolve the strategy in response to team goals and emerging data
lead multidisciplinary TSRS teams
partner with project teams developing therapeutics leveraging a variety of modalities (including biotherapeutics, small molecules and RNA therapies)
treat diseases in inflammation, oncology and/or cardiometabolic diseases, including obesity and rare diseases
develop subject matter expertise related to a specific modality, therapeutic area, or safety concern
present nonclinical safety issues at national and international regulatory meetings
participate in external industry initiatives to improve drug safety assessment paradigms
Requirements
Doctorate degree in Toxicology or a related scientific field, and 4 years of experience OR Master’s degree and 7 years of experience OR Bachelor’s degree and 9 years of experience
Excellent and professional communicator; proven ability to influence a broad spectrum of partners toward achieving business goals
A minimum of 10 years of drug development experience, at all stages of development including late-stage assets and interactions with global regulatory agencies for IND/CTA and NDA/BLA filings
Expertise in the field of immunology, either through immune-toxicology, immune-oncology or immunology related drug-target support.
End-to-end small and large molecule safety assessment experience across multiple therapeutic areas and modalities potentially including antibody drug conjugates and T-cell engagers
External visibility as a toxicology expert as demonstrated by a strong external presentation and publication record and leadership of external collaborative groups
Comfortable operating as a cross-functional and inter-functional thought partner on multi-disciplinary teams across R&D functions
Experience supporting business development efforts in the conduct of due diligence evaluations as translational safety team member
Experienced scientific leader with direct or matrixed management experience
Diplomate of the American Board of Toxicology
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
flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
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