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$84k–$114k/yr
Full-time
high school, associate degree, bachelor degree, postgraduate degree
Retirement And Savings Plan, Group Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Disability Insurance
Posted 24d ago
~40 hrs/week
Responsibilities
Lead the skill development of Local Study Operations Managers and oversee the delivery of the country's clinical study portfolio. Drive operational efficiency, manage resource allocation, and ensure alignment between local execution and global R&D strategies.
Requirements
Requires a degree with corresponding years of clinical execution experience (ranging from 2 years for a Doctorate to 12 for a High School diploma) and at least 2 years of people management experience. Preferred candidates have extensive biopharmaceutical research experience and a strong understanding of local regulatory requirements.
Full job description
Career Category
Research
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 ourfocus 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.
Local Study Operations Line Manager
What you will do
Let’sdo this.Let’schange the world.In this role, you will lead the skill development of Local Study Operations Managers, ensuring effective trial implementation within the country and strong alignment with global strategies. You will oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM.Working in close partnership with the Country GSSO Head, you will help foster, enhance, and sustainan optimalclinical research environment that supports global R&Dobjectives. Additionally, you will drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, andfacilitatingrobust knowledge sharing across the team.
Ensure the successful delivery of the study portfolio assigned to LSOMs.
Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out.
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs.
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country.
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials.
Build andmaintaina high-performing team.
Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio.
Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio.
Support discussionsregardingstudy placement decisions based on country capabilities and growth potential.
Proactively evaluate risks, quality trends, and resource requirements; implement mitigation strategies and drive continuous improvement in country operations.
Lead initiatives to enhance operational efficiency and encourage sharing of best practices.
Manage resource allocation and workload distribution across LSOMs, including both FSP and FTE personnel, tooptimizetrial execution and align with global priorities.
Ensure adherence to regulatory and quality standards where applicable.
Collaborate with and support thecountryhead in engaging cross-functional stakeholders,aligning ontrial deliverables, and managing escalations.
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:
Doctorate degree & 2 years of clinical execution experience OR
Master’s degree & 6 years of clinical execution experience OR
Bachelor’s degree & 8 years of clinical execution experience OR
Associate’s degree & 10 years of clinical execution experience OR
High school diploma / GED & 12 years of clinical execution experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2years experiencedirectly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation ofresources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
7yearswork experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience managing multiple teams / direct reports across multiple clinical functions / trials
Experience at, oroversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials
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.
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 accomplishedpeople 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.
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical