Associate Director Study Start-up

Amgen SA; Northern (KY); Hybrid; USD 182,000 - 213,000; Full time

Benefits offered by this job

Flexible work models

Total Rewards Plan

Retirement and savings plan

Job summary

Amgen seeks an Associate Director Study Start-up to lead planning and execution across a global portfolio, ensuring clinical trials launch with quality, efficiency, and regulatory compliance.

You will manage Study Start-up Managers, drive end-to-end start-up activities from global to local, build team capability, and partner with functional leaders to strengthen operational readiness.

Qualifications

• Pharma and clinical trial processes and operations expertise; no relevant therapeutic knowledge required.
• Experience leading and managing global teams and project management experience.
• PhD with 3+ years clinical execution, or Masters with 7+ years, or Bachelors with 9+ years of clinical execution experience.
• Minimum 3 years’ experience directly managing people and/or leadership experience.

Responsibilities

• Lead and manage a team of Study Start-up Managers across multiple programs.
• Drive end-to-end study start-up planning and execution from global to local with milestones on time and within budget.
• Provide portfolio-level oversight of start-up performance, resources, risks, and metrics.
• Partner with hub leaders to strengthen study start-up capabilities and operational readiness.
• Embed start-up business processes through training and knowledge sharing.

Skills

Pharma expertise

Management experience

Veeva experience

Education

Doctorate degree + 3 years of clinical execution

Master's degree + 7 years of clinical execution

Bachelor's degree + 9 years of clinical execution

Associate's degree + 12 years of clinical execution

High school diploma + 14 years of clinical execution

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel likeyou’repart of something bigger,it’sbecause you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980,we’vehelped 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’llhelp 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’llthrive 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’sdo this.Let’schange the world. In this vital role you willdrive world-class study start-upplanning andexecution across a global portfolio, ensuring clinical trials launch with quality, efficiency, andspeed.

• Lead andmanage 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-upplanning andexecution 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. Thecandidateweseekisan individualwith the following qualifications.

Basic Qualifications:

• Pharma Expertise:Requires pharma and clinical trial processes and operationsexpertise; no relevant therapeutic knowledgerequired

• Management Experience:Requires experience leading and managing global teams and project management experience

• Tech Skills:No prior Veeva experiencerequired

• 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 3years’ experiencedirectly 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:

• 7yearswork 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’llsupport 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,comprisingof 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

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against seriousdisease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.