Director Global Early Development Clinical Ops

To deliver our exciting and extensive pipeline of products moving into clinical development, Global Development Operations (GDO) has committed to building a world class Early Development Clinical Operations Function. The leaders of this organization are crucial to the success of our early phase assets as they move through the development lifecycle. The Director Early Development Clinical Operations will partner closely with Executive Director Early Development Clinical Operations and other cross functional leaders in Development. These roles are based in the Thousand Oaks and South San Francisco offices.

The primary responsibility of the Director includes: Global single point of accountability for operational strategy, planning, risk assessment and mitigation, and overall execution of clinical trial programs

Responsibilities:

• Oversee the operational design, planning, and management of program studies
• Contribute to the development of the Clinical Development Plan (CDP)
• Establish and monitor performance standards and metrics for assigned portfolio
• Oversee the development of study timelines and budgets; identifies possible resource constraints across the program and makes appropriate recommendations
• Provide input into EGP
• Provide visibility to study assumptions through the Long Range Planning process

• Ensure cross-study consistency of clinical input in the development of study-specific plans, CRFs, and other documents, considering regional differences where needed
• Ensure inspection readiness for respective TAs

• Participate in scientific engagement and collaboration with thought leaders at conferences / congresses

• Responsible for resource management; partners with Finance to develop accurate assumptions and prudent allocation of resources
• Build and retain high-performing teams; supervise direct reports and conduct performance evaluations
• Design, update, and implement SOPs and train teams as needed

Basic Qualifications:

Doctorate degree and 4 years of clinical experience

OR

Master's degree and 8 years of clinical experience

OR

Bachelor's degree and 10 years of clinical experience

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

M.D., D.O., PhD, PharmD, MSc

11 + years work experience in life sciences or medically related field, including 8+ years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company

Previous management experience of direct reports, including management level staff

Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.