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Scientific Director

Amgen
Remote friendly (Washington, DC)
United States
Clinical Research and Development

Role Summary

The Translational Safety & Risk Sciences (TSRS) function at Amgen is seeking a Scientific Director to serve as a Project Toxicologist and a Subject Matter Expert, reporting to the Senior Director Head Therapeutic Area Strategy Leaders and Business Development Liaisons.

Responsibilities

  • Develop and implement a fit-for-purpose nonclinical safety strategy based on a strong scientific foundation, evolve the strategy in response to team goals and emerging data, and lead multidisciplinary TSRS teams.
  • As a project team representative (PTR), partner with project teams developing therapeutics leveraging a variety of modalities (including biotherapeutics, small molecules and RNA therapies) to treat diseases in inflammation, oncology and/or cardiometabolic diseases, including obesity and rare diseases.
  • There is potential for opportunities with broader Inflammation and/or Oncology Therapeutic Area responsibilities and to conduct scientific due diligence for business development opportunities in oncology and CMD therapeutic areas.
  • PTRs are encouraged to develop subject matter expertise related to a specific modality, therapeutic area, or safety concern.

Qualifications

  • Required: Doctorate degree in Toxicology or a related scientific field, and 4 years of experience OR
  • Required: Masterโ€™s degree and 7 years of experience OR
  • Required: Bachelorโ€™s degree and 9 years of experience
  • Required: Excellent and professional communicator; proven ability to influence a broad spectrum of partners toward achieving business goals
  • Preferred: 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
  • Preferred: Expertise in the field of immunology, either through immune-toxicology, immune-oncology or immunology related drug-target support.
  • Preferred: 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
  • Preferred: External visibility as a toxicology expert as demonstrated by a strong external presentation and publication record and leadership of external collaborative groups
  • Preferred: Comfortable operating as a cross-functional and inter-functional thought partner on multi-disciplinary teams across R&D functions
  • Preferred: Experience supporting business development efforts in the conduct of due diligence evaluations as translational safety team member
  • Preferred: Experienced scientific leader with direct or matrixed management experience
  • Preferred: Diplomate of the American Board of Toxicology