Amgen

Executive Director, Study Start-Up

Amgen

full-time

Posted on:

Location Type: Hybrid

Location: Thousand Oaks • California • Kentucky • United States

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Salary

💰 $281,634 - $336,501 per year

Job Level

Lead

About the role

  • Lead SSU Hub as a global center of excellence, defining and overseeing the global SSU capability strategy
  • Represent the SSU Hub in enterprise and governance forums, influencing portfolio decisions and ensuring start-up insights to inform program and study planning
  • Champion innovation and continuous improvement in start-up approaches, embedding digital solutions, predictive analytics, and harmonized ways of working across the global portfolio.
  • Shape the long-term vision and strategy of the SSU Hub, ensuring alignment with CPSO, GDO, and enterprise priorities
  • Integrate and harmonize strategies from the six sub-functions into a single global capability strategy, balancing standardization with local/regional adaptability
  • Act as the global escalation point for study start-up risks and issues, ensuring timely resolution and portfolio-level visibility
  • Embed within the industry - bringing outside ways of working and representing Amgen back into the industry
  • Build and develop a high-performing global SSU leadership team (Directors, Sr Managers) creating a culture of accountability, innovation and operational excellence
  • Drive consistent performance management, alignment, and calibration across sub-functions to ensure equitable resourcing and delivery
  • Oversee start-up planning and execution across all new studies globally, ensuring timelines and quality standards are consistently achieved
  • Maintain and strengthen cross-functional and global business relationships, representing the SSU Hub in governance forums and enterprise initiatives

Requirements

  • Doctorate degree and 6 years of clinical execution experience OR Master’s degree and 10 years of clinical execution experience OR Bachelor’s degree and 12 years of clinical execution experience AND 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
  • 12+ years’ work experience in life sciences industry, particularly focusing on clinical trial work, including 10+ years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
  • Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
  • Experience driving and leading organizations through​ cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs
  • Experience leading cross-functional / cross-geography / cross-trial teams, ensuring operational excellence and smooth decision-making; ability to escalate and resolve challenges in alignment with global study strategy priorities
  • Extensive knowledge of the clinical and pharmaceutical drug development process, from early to late-stage development with a deep understanding of relevant therapeutic areas to meet the highest scientific and regulatory standards
  • Adept in cross geography, cultural dynamics and running efficient global teams - Ability to lead and motivate geographically dispersed teams in an inclusive manner
  • Experience in assessing internal capabilities and identifying key capabilities to build training content, monitoring skill improvement, and drive competency builds across function and within teams
  • Demonstrates clear understanding of how to build collaborative networks across cross-functional teams, senior management, and external stakeholders, internally and externally to drive efficiency across processes
  • Big picture, proactive thinking with the ability to assess broad impacts across multiple product portfolios to identify innovative solutions
Benefits
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • life and disability insurance
  • flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical executionclinical trial managementbiopharmaceutical researchpredictive analyticsoperational excellenceresource allocationcross-functional change initiativestraining content developmentproblem-solvingglobal study strategy
Soft Skills
leadershipteam managementcross-functional collaborationinnovationaccountabilitycommunicationcultural dynamicsproactive thinkingrelationship buildingmotivation
Certifications
Doctorate degreeMaster’s degreeBachelor’s degree