4 days ago

Associate Director Study Start-up

Amgen

Hybrid
Full Time
$200,000
Hybrid

Job Overview

Job TitleAssociate Director Study Start-up
Job TypeFull Time
CategoryCommerce
Experience5 Years
DegreeMaster
Offered Salary$200,000
LocationHybrid

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Job Description

Associate Director Study Start-up at Amgen

Join Amgen’s Mission of Serving Patients.

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Study Start Up Hub – Associate Director Study Start-up

 

What You Will Do

Let’s do this. Let’s change the world. In this vital role, you will drive world-class study start-up planning and execution across a global portfolio, ensuring clinical trials launch with quality, efficiency, and speed.

  • Lead and manage a team of Study Start-up Managers, ensuring 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, delivering 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, escalating risks with solution-focused recommendations.
  • Build team capability through coaching, mentoring, performance management, and role modelling of best practices in study start-up delivery.
  • Partner with functional and hub leaders to strengthen study start-up capabilities, ways of working, and operational readiness across the organisation.
  • Own and embed study start-up business processes, ensuring consistent application through training, knowledge sharing, and continuous improvement.
  • Foster a collaborative, high-engagement culture that encourages innovation, learning, and the sharing of knowledge and best practice.
  • Contribute to the evolution of the Study Start-up Hub model, shaping future ways of working through feedback, insights, and continuous improvement initiatives.

 

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.

Basic Qualifications:

  • Pharma Expertise: Requires pharma and clinical trial processes and operations expertise; no relevant therapeutic knowledge required.
  • Management Experience: Requires experience leading and managing global teams and project management experience.
  • Tech Skills: No prior Veeva experience required.
  • 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.
  • In addition to meeting at least one of the above requirements, you must have a minimum of 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

  • 7 years work experience in life sciences industry, particularly focusing on clinical trial work, including 5 years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company.
  • Experience managing multiple teams / direct reports across multiple clinical functions.

 

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The annual base salary range for this opportunity in the U.S. is $182,145 - $212,860.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and 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.

 

Key skills/competency

  • Clinical Trials
  • Study Start-up
  • ICH-GCP
  • Regulatory Requirements
  • Project Management
  • Global Team Leadership
  • Pharma Operations
  • Biopharmaceutical Research
  • Performance Management
  • Process Improvement

Tags:

Associate Director Study Start-up
Clinical trials
Study start-up
Global execution
Team leadership
Project management
ICH-GCP
Regulatory compliance
Process improvement
Portfolio oversight
Stakeholder partnership
Veeva
CTMS
eTMF
Clinical data systems
Project management software
Document management
Regulatory systems
Analytics platforms
Reporting tools
Collaboration tools

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How to Get Hired at Amgen

  • Research Amgen's culture: Study their mission, values, patient-centric focus, and biotech leadership.
  • Tailor your resume: Highlight extensive clinical trial experience, global team leadership, and process improvement successes.
  • Showcase Study Start-up expertise: Emphasize deep knowledge of ICH-GCP, regulatory requirements, and efficient global study execution.
  • Prepare for behavioral questions: Demonstrate collaboration, strategic problem-solving, and effective team management skills.
  • Network strategically: Connect with Amgen professionals on LinkedIn to gain insights and express genuine interest.

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