Director, Study Evidence & Readiness

Amgen•Thousand Oaks, CA

1d•$185,847 - $251,441

About The Position

The Director, Study Evidence & Readiness leads Amgen’s Study Evidence and Readiness function, encompassing TMF Operations and Inspection Readiness. The role ensures clinical studies can continuously demonstrate appropriate trial conduct through complete, reliable, retrievable, and inspection-ready evidence. It sets strategy and priorities, provides integrated oversight of TMF health and readiness across the study portfolio, and leads global teams and improvement initiatives. The position also manages departmental structure and resources, develops and maintains processes and guidance, partners across functions to resolve evidence issues, reports on evidence health and risks, and supports audits and inspections. Amgen’s mission is to serve patients living with serious illnesses through research, manufacturing, and delivery of innovative medicines. The company describes its culture as collaborative, innovative, and science based, and offers professional and personal growth support through its Total Rewards Plan and benefits package.

Requirements

Doctorate degree and 4 years of directly related experience or equivalent; or master’s degree and 8 years of directly related experience or equivalent; or bachelor’s degree and 10 years of directly related experience or equivalent.
At least 4 years of direct managerial and/or leadership experience or equivalent.
Preferred qualification: PhD, PharmD, MSc, BSc, or RN.
Preferred: 11 years of work experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research at a biotechnology company, pharmaceutical company, or CRO.
Preferred: Leadership experience managing direct reports, including management-level staff.
Preferred: Experience in TMF operations and inspection readiness, preparation, inspection support, or response.
Preferred: Experience managing or overseeing external clinical research vendors.
Preferred: Knowledge of global GCP and regulatory expectations for clinical trial conduct, TMF records, and inspection readiness, along with risk-based oversight, evidence health, resource planning, and organizational capacity.
Preferred: Experience leading cross-functional work in a matrix organization, including projects, budgets, timelines, and quality metrics; ability to build relationships, lead change, develop high-performing teams, and communicate clearly.

Nice To Haves

PhD, PharmD, MSc, BSc, or RN qualification.
11 years of work experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research at a biotechnology company, pharmaceutical company, or CRO.
Leadership experience managing direct reports, including management-level staff.
Experience in TMF operations and inspection readiness, preparation, inspection support, or response.
Experience managing or overseeing external clinical research vendors.
Knowledge of global GCP and regulatory expectations for clinical trial conduct, TMF records, and inspection readiness, along with risk-based oversight, evidence health, resource planning, and organizational capacity.
Experience leading cross-functional work in a matrix organization, including projects, budgets, timelines, and quality metrics; ability to build relationships, lead change, develop high-performing teams, and communicate clearly.

Responsibilities

Set strategy and priorities for TMF Operations and Inspection Readiness, aligning evidence stewardship with continuous inspection readiness.
Lead and develop global teams, including line management of Inspection Readiness Senior Managers and Managers; set goals, manage performance and engagement, and build succession and capability plans.
Provide integrated oversight of TMF health, critical evidence, inspection readiness, and material evidence gaps across the study portfolio; establish metrics, thresholds, and escalation recommendations.
Plan and manage departmental structure, capacity, resources, budget, suppliers, training, and business continuity to meet portfolio needs.
Lead improvement initiatives to strengthen evidence quality, completeness, retrievability, and readiness; represent the function in process improvement, standards development, and integration work.
Develop and maintain TMF and inspection-readiness processes, policies, SOPs, work instructions, and related materials, applying current procedures, industry practice, and relevant regulatory expectations.
Partner cross-functionally to resolve evidence issues, interpret trends, apply root-cause insights, and drive sustainable improvement.
Provide leadership reporting on evidence health, readiness risks, remediation progress, and portfolio trends; contribute to leadership forums and governance committees.
Support audits and inspections, including preparation, response support, and lessons learned for TMF and inspection-readiness process areas; build relationships with internal and external experts.