Associate Director Study Start-up

Amgen; Northern (KY); On-site; USD 182,000 - 213,000; Full time

Benefits offered by this job

Competitive benefits

Annual bonus potential

Stock-based incentives

Flexible remote work options

Job summary

Amgen Inc. is seeking an Associate Director for Study Start-up to lead a global team and oversee end-to-end planning and execution of study start-ups across multiple programs. You will ensure timely, compliant delivery in line with ICH-GCP standards, while building capability and improving processes within the hub model.

The role emphasizes cross-functional collaboration, strategic oversight, and the evolution of study start-up practices to support rapid, high-quality trial launches.

Qualifications

• Pharma and clinical trial operations expertise.
• 3+ years of direct people management.
• Experience leading global teams and programs.
• Knowledge of ICH-GCP and regulatory requirements.

Responsibilities

• Lead and manage a team of Study Start-up Managers across programs.
• Drive end-to-end study start-up planning from global to local.
• Provide portfolio-level oversight and escalate risks with solutions.
• Foster capability and continuous improvement in process and ways of working.

Skills

Pharma & clinical trial operations

Global team leadership

Project management

ICH-GCP knowledge

Regulatory compliance

Education

Doctorate degree in a relevant field

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Job description

## Associate Director Study Start-upApplyremote type: Remotelocations: United States - Remotetime type: Full timeposted on: Posted Todayjob requisition id: R-249972## **Career Category**Clinical## ## **Job Description****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 candidatewe 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**Apply now****for a career that defies imagination**Objects in your future are closer than they appear. Join us.**careers.amgen.com**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 serious disease.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 to participate in 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.