JOB SUMMARY

• Reporting to the Head of Site & Country Operations, the Pfizer Oncology Division (POD) Director of Clinical Site Operations (DCSO) is a dynamic leader supporting the Head of Site & Country Operations to deliver their strategic vision and representing POD operations at the country level.
• Represents POD within country establishing and cultivating relationships with KOLs, strategic sites/ networks, HAs/governments and industry clinical research associations to become the Face of Pfizer and positioning Pfizer as a partner of choice within their country.
• Supports and cultivate a collaborative partnership with Medical Affairs, creating a framework for an end-to-end continuum linking investigator relationships to future prescribers within the country.
• Demonstrated knowledge and understanding of the local marketplace, and industry trends, providing insights and enabling teams to successfully position and deliver oncology clinical trials
• Leads the GSSO organization within their country to deliver the Pfizer oncology portfolio, driving a meaningful increase in patient recruitment whilst meeting and exceeding speed and quality deliverables and best in class cycle times to bring medicines to patients faster.

JOB RESPONSIBILITIES

• The DCSO is accountable for ensuring appropriate Site Care Partner (SCP), and Site Monitor resources are in place to deliver on, country and site-level end to end activities in-line with study milestones in the designated country. This role provides line management and oversees the Site Care Partner and Site Monitor ensuring compliance with training requirements. The DCSO is accountable to ensure overall monitoring, operational site partnership, management and oversight activities within a designated country and supervises the monitoring, oversight activities of sites to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.
• Overall accountability for the Growth and Development of the Site Operations organization (Managers and Individual Contributors) and to ensure compliance with training requirements.
• Partner with the FSP Manager of Site Care Partner & Site Monitors as described in standard contracts with the FSP organization to oversee FSP SCP and Site Monitor roles. DCSO is accountable to ensure timely resource assignments and will provide feedback on the performance of FSP resources.
• Where required, perform joint site visits with direct reports to assess performance.
• Accountable for country budget in accordance with financial expectations.
• Demonstrate leadership in the resolution of site/country issues to ensure project delivery, patient safety, quality and maintain investigator site relationships
• Coordinates cross functionally with Study Start Up, Operational Analytics and Quantitative Sciences (OARS), Patient Recruitment and Study Management, providing local knowledge and critical input to country and site selection. investigator site relationships
• Collaborate with country regulatory/regional Clinical Trial Regulatory operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their country.
• The DCSO represents Pfizer Oncology Divisions (POD) as the operational partner for the local country/regional Medical Affairs teams. This role drives the end-to-end connection of country stakeholders across the portfolio and collaborates with other stakeholders at the global level to ensure country input into the clinical development and country strategy.
• Responsible for country level input into country selection, pre-feasibility, study design and site identification and selection and ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders.
• The DCSO provides insights on local trends to facilitate the conduct of clinical trials and where appropriate is responsible for developing analyses and offering options for mitigation (both at the country and site level); collaborating with and informing stakeholders (e.g., study/program teams, local, Medical Affairs teams, local CROs, Medical Quality Assurance, etc.), as needed.
• Working within the directions of a global strategy, build portfolio-aligned, investigational sites/network relationships and participating in local industry forums to shape performance of ethical clinical research, as needed and shapes the local clinical research environment by promoting GCP, ethics, regulatory process and investigator training.
• The Director of Site operations is a Subject Matter Expert (SME) on country / site management, processes and works with their Head of Site & Country Operations to facilitate the sharing of regional/ country intelligence/expertise and best practices within cross functional lines as needed.
• As applicable, act as the POD representative on Country Medical Councils to ensure transparent communication within relevant Pfizer stakeholders in the country.

QUALIFICATIONS / SKILLS

Basic Qualifications

• Bachelor’s degree with 10+ years of pharmaceutical/Biotech clinical development experience
• Master’s degree with 9+ years of pharmaceutical/Biotech clinical development experience
• PhD/MD degree with 7+ years of pharmaceutical/Biotech clinical development experience
• 8+ years of people management / leadership
• Must be fluent in English. Local language capabilities are an advantage in this role.

Skills

• 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 navigate the right stakeholder internal and externally for the required escalation
• when appropriate and resolve issues in a timely manner
• Ability to lead change with can-do attitude and support team to go through change management cycle.
• Demonstrated ability to engage with senior stakeholders internally and externally to the organization.
• Ability to work effectively with line support functions including finance, PX across the 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 development of core competencies.

Requirements

• Availability to travel up to 50% of time.

ORGANIZATIONAL RELATIONSHIPS

• Provide the primary groups or key role(s) that this role will interact with as a regular part of the Job responsibilities. Include any external interactions as appropriate.

• Partners with local Medical Affairs and colleagues at country and regional level
• Partners with Internal stakeholders to ensure full awareness of Pfizer trial portfolio at country level.
• Ensures close collaboration with country and/or regional managers/leadership and key global stakeholders (e.g., MQA, Regulatory Affairs, CTRO, PharmSci, Legal, Drug Safety Unit, PRD, etc.)
• Partners with Study Team (e.g., Clinician, Clinical Study team Lead, Study Manager, Data Manager, Project Planner, SUPM), and Country/Regional Study Team Members (Country Operations Manager (SOM), (SAP), (CTA), ICL and their line manager, as needed
• Partners with OARS, Patient Recruitment teams as needed
• Partners with contracted organizations e.g., FSP monitoring, and 3rd party vendors as applicable
• When necessary, represents GSSO as the single point contact for the country. This role is key in providing clinical development portfolio updates to country management.
• Represents Pfizer in key external bodies in support of enhancing the Clinical Trial Environment at Country Level.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.