Senior Director, Translational Safety and Bioanalytical Sciences - PTR Team Leader

Career Category

Scientific

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Senior Director, Translational Safety and Bioanalytical Sciences - PTR Team Leader

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What you will do

Let’s do this. Let’s change the world. Amgen’s Translational Safety and Bioanalytical Sciences (TS&BA) function is actively seeking a Senior Director to join the Leadership Team overseeing the Portfolio Scientific Leadership (PSL) function. As a crucial member of the PSL Leadership Team, the Senior Director will play a strategic role in guiding the PSL Team, which consists of Project Team Representatives (PTRs) and Data Scientists.

In this pivotal position, the Senior Director will provide overarching leadership for a group of PTRs within TS&BA, contributing to the seamless progression of projects from discovery through registration and life cycle management. Our team's scope extends across Amgen's Therapeutic Areas, including Oncology, Inflammation, Rare Disease, and General Medicine/Cardiometabolic Disease, encompassing biosimilars programs and a wide array of modalities, such as small molecules, large molecules, and RNA therapeutics.

The Senior Director will contribute as a Senior Advisor on the TS&BA Portfolio Scientific Advisory Committee, act as delegate and advisor to the Executive Director US and EU Heads of PSL for key meetings (e.g., the TS&BA Portfolio Impact Meeting), represent TS&BA on R&D Initiatives, and actively contribute to the evolution of TS&BA to enable our rolling 3-year strategic vision. It is anticipated that the Senior Director will hold subject matter expertise and continue to develop as a subject matter expert (SME) in a particular area e.g., a toxicology specialty area, TA, or modality. The Senior Director will participate in external industry initiatives to improve drug safety assessment paradigms.

As a people leader for TS&BA PTRs, you will further develop the scientific, drug development, and leadership skills of the team through coaching, identifying experiential learning opportunities, and ensuring individually tailored career developments plans are continuously evolved. In partnership with your team of PTRs, you will influence the development of fit-for-purpose translational safety strategies based on a strong scientific foundation, flexibly evolve the strategy in response to team goals and emerging data and encourage effective team behaviors. A strong understanding of the expertise and toolbox available at Amgen will be developed through networking to fully leverage our internal and external resources. It is expected that you will apply your toxicology, drug development, and regulatory experience to the novel targets and/or modalities in Amgen’s pipeline.

The Senior Director will report to the Executive Director of TS&BA Portfolio Scientific Leadership (US) and is expected to periodically travel to Amgen R&D sites within the USA and EU.

The successful candidate will have:

• Organizational leadership experience including leadership of translational safety project team representatives, familiarity with leading global teams with cultural intelligence, and proven track record in people development, leadership of critical initiatives and leading within a dynamic organization.
• Expert knowledge of principles and theories in Biopharmaceutical Toxicology and Pharmacology and proficient knowledge of related and adjacent disciplinary areas such as Pharmacokinetics.
• In-depth knowledge of the functions and processes behind drug discovery and development, a strong understanding of cross-functional needs, and the ability to develop integrated plans to enable successful development of a therapeutic.
• A track record of successful nonclinical safety submissions to global Health Authorities including weight-of-evidence assessments and briefing documents, and effective responses to regulatory questions.
• Deep expertise in stages of development immediately preceding First-in-Human and continuing through clinical trials, registration, and life cycle management with a passion for biological understanding and application of biological insights to program success.
• Experience developing therapeutics of various modalities, e.g., small and large molecules, including fit-for-purpose study designs and selection of nonclinical species.
• Familiarity with ICH and Regional Regulatory guidance and working knowledge of GLP regulatio