Director, Site Management & Monitoring

About the role

Supporting Pfizer Oncology, the Director of Site Management and Monitoring (DSMM), in partnership with the Director of Clinical Site Operations (DCSO) is accountable for ensuring appropriate Site Care Partner (SCP) resources are in place to deliver on country and site-level end to end study start up and site management activities in-line with study milestones in the designated for the United States, as well as providing line management and overseeing the job function of the Site Care Partner. This role partners cross functionally with others in Study Start Up (Start Up Project Management (SUPM), Site Activation Partner (SAP), Clinical Trial Assistant (CTA), Investigator Contracts Lead (ICL)), Optimization, Analytics, and Recruitment Solutions (OARS), Patient Recruitment and Study Management to provide input to country and site selection and collaborate with country regulatory/regional Clinical Trial Regulatory Operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their cluster when applicable. The role also executes investigator site/recruitment strategies and site-level end to end study start up, site management and monitoring activities. The Director of Site Management and Monitoring will lead, contribute to, and implement strategic initiatives as a representative of the GSSO Leadership. They will also lead initiatives that shape the clinical development environment within their country/cluster/region to facilitate Pfizer 's clinical development goals and scientific leadership. Responsibilities: Lead and coach allocated resources within assigned country/cluster/region. Overall accountability for the Growth and Development of the Site Operations organization Oversee job function as described in the Site Care Partners & Line Manager of SCPs job description and ensure compliance with training requirements. Closely liaise with the FSP Manager of Site Care Partner as described in standard contracts with the FSP organization to oversee FSP SCP roles. Where required, perform joint site visits with direct reports to assess performance. Demonstrate leadership in the resolution of site/country/cluster/regional issues to maintain site start-up, quality and solid investigator site relationships. Establish consistent direction and priorities across assigned countries/cluster/region. Responsible for country level input into country selection, pre-feasibility, study design and site identification and selection; when necessary, support and champion existing associated processes. Ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders. Demonstrate Therapy Area expertise, where appropriate. Responsible for timely and quality site start-up including activation. Mitigate systematic deficiencies in clinical trial conduct across sites, to improve quality and patient safety in selected investigational sites. Ensure sites with virtual monitoring and oversight capabilities are identified and enabled, as applicable. Share country/cluster/regional issues and trends with stakeholders (e.g., study/program teams, local Medical Affairs teams, local CROs, Medical Quality Assurance, etc.), as needed. (SUPM, CTA, SAP, ICL,), regulatory/CTRO, Investigator Payment leads, OAQS, Patient recruitment and study management to drive successful portfolio delivery in-country. Driving effective resource management across portfolio for given country to ensure balanced resource allocation for SCP and site monitors across the Therapeutic Areas (TA) and regions. Requirements: Must be fluent in English. Local language capabilities are an advantage in this role. In general, candidates for this job would hold the following levels of education/ experience: BS/BSc/MS/MSc or equivalent and extensive clinical research experience, PhD/MD or equivalent and extensive clinical research experience Extensive knowledge (minimum 10 years) of clinical trial methodologies with proven ability to deliver high quality clinical trial conduct obtained while working with a multi-national pharmaceutical company and/or clinical research organization. Demonstrated People management experience Ability to lead and manage diverse teams. Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities. Ability to lead and influence a matrix environment, capable of driving initiatives across GSSO. Demonstrated understanding of People Experience (PX) procedure and policies at global and local level. Demonstrated ability to engage with senior stakeholders internally and externally to the organization. Ability to work effectively with line support functions including finance, PX acrossthe region. Ability to both manage the resources required to deliver on organizational commitments and perform specific tasks of the roles managed. Ability to effectively coach and train direct reports including management of escalated issues from sites / investigators, and developme