Scientific Director

Amgen•South San Francisco, CA

22h

About The Position

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. You will 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 and lead multidisciplinary TSRS teams. As a project team representative (PTR), you will 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. The successful candidate will have: A proven sustained track record of scientific leadership in drug development (including IND/CTA filings) as well as in nonclinical development with a strong understanding of cross-functional needs and the ability to develop integrated plans to enable successful development of a therapeutic. Experience with matrix management and demonstrated effective mentoring skills. Presented nonclinical safety issues at national and international regulatory meetings and participate in external industry initiatives to improve drug safety assessment paradigms What we expect of you We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is innovative with these qualifications.

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 proven sustained track record of scientific leadership in drug development (including IND/CTA filings) as well as in nonclinical development with a strong understanding of cross-functional needs and the ability to develop integrated plans to enable successful development of a therapeutic.
Experience with matrix management and demonstrated effective mentoring skills.

Nice To Haves

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

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) to treat diseases in inflammation, oncology and/or cardiometabolic diseases, including obesity and rare diseases.
Conduct scientific due diligence for business development opportunities in oncology and CMD therapeutic areas.
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