Assoc Dir Global Site & Study Operations

Amgen • Warren, MO

1d

About The Position

Career Category Clinical Development Job Description Accountabilities •The Country Study and Site Operations Head is accountable to drive all country and hub & spoke execution and quality measures, including study operations, site operations, and site engagement, while ensuring operational capabilities support the delivery of the geographic portfolio with high-quality data in compliance with local regulations. •Ensure study execution aligns with global strategies across trials and act as a key advisor for country commitments. •Provide leadership and line management to the Country/Hub team, offering clear guidance, fostering capability development, and driving portfolio objectives. •Represent the country strategically in organizational initiatives at all levels. •Lead the Country Management Team (CMT). . Ensure Adequate resourcing Responsibilities •Accountable for all study execution in assigned geography and quality metrics including delivering study start-up, patient enrollment, retention trends, and data flow metrics in alignment with global strategies across trials, serving as key advisor for country commitments •Oversee clinical study budgets and forecasting to ensure efficient use of resources and financial accountability. •Build, lead, and develop the Country/Hub team to effectively manage resources, ensuring appropriately skilled and high-performing staff to deliver the portfolio and meet organizational deliverables. •Drive country site engagement by leading SEL AD and/or SELs, aligning with global strategy, ensuring compliance, strengthening partnerships, and securing Partner-of-Choice positioning through innovation and leadership collaboration.” •Shape and foster collaboration between local functional teams and global study teams to drive delivery of study portfolio in assigned geography •Partner with internal stakeholders to monitor study progress and drive local actions plan & issue resolution, and aggregates country progress and challenges for senior management •Represent country in governance meetings, communicating cross-study progress to region / CPSO •Advocate for study placement in considerations of strengths and growth opportunities of assigned geography •Lead internal and external meetings to ensure delivery on portfolio targets •Key advisor for site selection, and identifies & communicates priority sites, allocating resources as required •Point of escalation to support resolution of country-wide issues including risks which impact delivery or quality of clinical trials and/ patient safety •Lead country-level risk assessments and implement mitigation strategies to ensure patient safety, compliance, and trial continuity •Oversees vendor selection, setup, performance oversight across local roles (study delivery, monitoring) in alignment with budget considerations and serves as point-of-escalation •Promote continuous improvement and best practice sharing to enhance operational efficiency and site engagement. •Build and develop strong local leadership and study teams to deliver on portfolio goals and support long-term organizational capability •Ensures adherence to key requirements (e.g., ICH-GCP, SOP, country regulations), study inspection readiness, internal audits and CAPA processes •Work with SDRM to ensure timely and adequately resourcing for all roles • . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

Responsibilities

• Accountable for all study execution in assigned geography and quality metrics including delivering study start-up, patient enrollment, retention trends, and data flow metrics in alignment with global strategies across trials, serving as key advisor for country commitments
• Oversee clinical study budgets and forecasting to ensure efficient use of resources and financial accountability.
• Build, lead, and develop the Country/Hub team to effectively manage resources, ensuring appropriately skilled and high-performing staff to deliver the portfolio and meet organizational deliverables.
• Drive country site engagement by leading SEL AD and/or SELs, aligning with global strategy, ensuring compliance, strengthening partnerships, and securing Partner-of-Choice positioning through innovation and leadership collaboration.”
• Shape and foster collaboration between local functional teams and global study teams to drive delivery of study portfolio in assigned geography
• Partner with internal stakeholders to monitor study progress and drive local actions plan & issue resolution, and aggregates country progress and challenges for senior management
• Represent country in governance meetings, communicating cross-study progress to region / CPSO
• Advocate for study placement in considerations of strengths and growth opportunities of assigned geography
• Lead internal and external meetings to ensure delivery on portfolio targets
• Key advisor for site selection, and identifies & communicates priority sites, allocating resources as required
• Point of escalation to support resolution of country-wide issues including risks which impact delivery or quality of clinical trials and/ patient safety
• Lead country-level risk assessments and implement mitigation strategies to ensure patient safety, compliance, and trial continuity
• Oversees vendor selection, setup, performance oversight across local roles (study delivery, monitoring) in alignment with budget considerations and serves as point-of-escalation
• Promote continuous improvement and best practice sharing to enhance operational efficiency and site engagement.
• Build and develop strong local leadership and study teams to deliver on portfolio goals and support long-term organizational capability
• Ensures adherence to key requirements (e.g., ICH-GCP, SOP, country regulations), study inspection readiness, internal audits and CAPA processes
• Work with SDRM to ensure timely and adequately resourcing for all roles

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed