Postes à Sao Paulo, United States

Responsibilities

• Actively partners with cross-functional stakeholders to support R&D strategy. Leadership of GSO-SM team in country/hub.
• Oversight of local strategy including feasibility and country operational plans. Accountable for local feasibility activities and approve final site selection.
• Review and approve forecast, baseline and re-baseline study targets. Accountable for execution of clinical studies.
• Ensure timely collection and validation of clinical trial data.
• Responsible for timely, quality communication to both functional / cross-functional teams to support data monitoring, flow, and validation activities.
• Partner with GSO-SM FSP and GCPM organization to monitor study progress and drive local action plans.
• Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and Local Regulations. Risk mitigation and quality management.
• Proactively identifies risks and develops risk mitigation strategies to ensure operational effectiveness.
• Interpret analytics to monitor clinical study delivery (timelines, enrollment, data flow).
• Representing GSO-SM in internal and external stakeholder interactions. Performance management of local staff and oversight of GSO-SM Functional Service Provider(s) (FSP).
• Partner to maintain appropriate resource levels and manage within budget.
• Supporting local and global process improvement initiatives.
• Engage local cross-functional teams (e.g. Medical, Scientific Affairs and GRAAS) to maximize local support of clinical trials.
• Maintain relevant therapeutic knowledge and clinical research best practices.
• Participate in external industry activities (e.g. pharma associations, regulatory agencies).

Basic Qualifications

• Doctorate degree and 4 years of clinical experience OR Master’s degree and 8 years of clinical experience OR Bachelor’s degree and 10 years of clinical experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Preferred Qualifications

• M.D., D.O., PhD, PharmD, Master’s Degree.
• 11+ years work experience in life sciences or medical field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company).
• Previous management experience of direct reports, including management level staff. Experience at, or oversight of, outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.). Country clinical operations experience and/or regional study management experience.
• Detailed knowledge of US and international clinical trial management including regulations and guidelines.
• Advanced knowledge of global clinical trial management.
• Clinical trial processes and operations.
• Extensive knowledge of ICH/GCP, local regulations, clinical trial environment, requirements, and guidelines. Project and Program management including oversight of quality, study deliverables, budgets and timelines.
• Various therapeutic area knowledge.
• Fluency in written and spoken English.
• Clinical trial management systems and reporting tools.

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy.