Associate Director Study Start-up
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assuranceveevagcpcro
Job description
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 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 o
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