Associate Director, Study Start-up

Amgen

. Drive world-class study start-up planning and execution across a global portfolio .

Posted 9/23/2026full-timeRemote • United StatesSenior💰 $182,145 - $212,860 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in driving study start-up planning and execution within the life sciences industry, ensuring compliance with ICH-GCP and regulatory requirements while managing global teams and delivering projects on time and within budget.

Highest-signal resume keywords

Pharma And Clinical Trial Processes ExpertiseProject Management ExperienceLeadership Experience Managing Global TeamsClinical Execution ExperienceBiopharmaceutical Clinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Study Start-Up PlanningStudy Start-Up ExecutionPerformance ManagementRisk ManagementCoaching And MentoringContinuous ImprovementOperational ReadinessResource AllocationMetrics AnalysisCompliance Management

Soft Skills

Collaborative Culture BuildingSolution-Focused RecommendationsKnowledge Sharing

Industry Keywords

ICH-GCPLife Sciences IndustryClinical TrialsBiotechPharmaceutical Company

About the role

Key responsibilities & impact

Drive world-class study start-up planning and execution across a global portfolio
Lead and manage a team of Study Start-up Managers
Ensure high-quality, compliant study start-up delivery across multiple programs and therapeutic areas
Drive end-to-end study start-up planning and execution from global to local
Deliver milestones on time, within budget, and in line with ICH-GCP and regulatory requirements
Provide portfolio-level oversight of study start-up performance, resourcing, and delivery metrics
Escalate risks with solution-focused recommendations
Build team capability through coaching, mentoring, performance management, and role modelling best practices
Partner with functional and hub leaders to strengthen study start-up capabilities, ways of working, and operational readiness
Own and embed study start-up business processes
Deliver training, knowledge sharing, and continuous improvement
Foster a collaborative, high-engagement culture
Contribute to the evolution of the Study Start-up Hub model and future ways of working

Requirements

What you’ll need

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Doctorate degree and 3 years of clinical execution experience OR Master’s degree and 7 years of clinical execution experience OR Bachelor’s degree and 9 years of clinical execution experience OR Associate’s degree and 12 years of clinical execution experience OR high school diploma/GED and 14 years of clinical execution experience
Minimum of 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Managerial experience may run concurrently with the required technical experience
7 years’ work experience in the life sciences industry, particularly clinical trial work, including 5 years of biopharmaceutical clinical research experience at a biotech or pharmaceutical company (preferred)
Experience managing multiple teams/direct reports across multiple clinical functions (preferred)
No prior Veeva experience required

Benefits

Comp & perks

Comprehensive employee benefits package
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Career development opportunities
Work/life balance support