Senior Director of Clinical Site Operations

Location : France

The Senior Director of Clinical Site Operations works above Country/Cluster/Region, Area, and Department to sponsor, chair, or lead operational /strategic lines, in addition to significant strategic initiatives, to accomplish business objectives that are multifaceted and unique in complexity.

The Senior Director of Clinical Site Operations influences top management decisions that impact business directives.

The Senior Director of Clinical Site Operations builds and leverages constructive relationships externally and cross-functional internally. Influence regulatory authority or leading/contribute significantly in industry Clinical Research association and/or drive strategic initiative and innovative methodology implementation across Global Business Units.

The Senior Director of Clinical Site Operations is a significant Subject Matter Expert of the principles, concepts, and theories in an assigned discipline and represents the Enterprise to influence direct business drivers associated.

The Senior Director of Clinical Site Operations may serve as delegate to the Area Head for certain key activities, initiatives, and deliverables.

The Senior Director of Clinical Site Operations (Senior DCSO)  is accountable for ensuring appropriate Site Care Partner (SCP), as well as Site Monitor resources are in place to deliver on, country and site-level end to end study start up, management and monitoring activities in-line with study milestones in the designated countries/clusters/regions, as well as providing line management and overseeing the job function of the Site Care Partner and Site Monitor.

The role is also accountable to ensure overall monitoring, operational site management and oversight activities within a designated country/cluster/region 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.

This is a strategic role that coordinates 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)), Operational Analytics and Quantitative Sciences (OAQS), 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, management and monitoring activities.

The Senior Director of Clinical Site Operations represents Pfizer Research & Development (PRD) as the in- country/cluster/regional point of contact for the local country/regional Medical Affairs teams. This role drives the end-to-end connection of country/cluster/regional stakeholders across the portfolio and collaborates with other stakeholders at the global level to ensure country input into the clinical development and country strategy.

This role is also responsible for the communication of the future trial portfolio to appropriate country/cluster stakeholders. Applicable to certain countries/clusters/regions, the role also represents site operations in therapeutic area/asset/study-level discussions, working in coordination with other key PRD roles, including but not limited to, Clinician, Directors of Study Management and Clinical Study Team Leads.

The Senior Director of Clinical Site Operations 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. For example, this role actively manages risks and identifies opportunities for clinical trial conduct through engagement with local clinical development leaders and/or regulatory authorities, activate participates in local industry forums, builds portfolio-aligned, investigational sites/network relationships. To shape performance of ethical clinical research, as needed (e.g., DCT readiness/ virtual monitoring, and drive the cycle times reduction).

The Senior Director of Clinical Site Operations provides insights on local/regional 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/cluster and site level) on the trial’s conduct.

JOB RESPONSIBILITIES

Management of Site Care Partner roles (including line managers), and Site Monitors

Lead and coach allocated resources within assigned country/cluster/region.

Overall accountability for the Growth and Development of the Site Operations organization (Managers and Individual Contributors)

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. Senior DCSO will direct resource assignments and will provide feedback on performance of FSP Site Care Partners

Oversee job function as described in the Site Monitors Job description and ensure compliance with training requirements

Closely liaise with the FSP Manager of Site Monitors as described in standard contracts with the FSP organization to oversee FSP Site Monitor roles. Senior DCSO will direct resource assignments and will provide feedback on performance of FSP Site Monitors

Where required, perform joint site visits with direct reports to assess performance.

Manage country/cluster/regional budget in accordance with financial expectations.

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.

Country/Cluster/Regional Environment & Across Site/Study Management:

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.

Responsible for the oversight of the operational delivery including the monitoring activities as performed by the selected Monitoring FSP or by partner CROs, safety and quality of sites in the country/cluster/region.

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.

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.

Collaborate with local contract organizations (e.g., CRO) as needed to ensure overall delivery, quality, local regulatory and GCP compliance.

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.

Shape local clinical research environment by promoting GCP, ethics, regulatory process and investigator training.

When required, contribute to area or global GSSO strategy by leading and participating in area or global initiatives.

The Senior Director of Site operations is a Subject Matter Expert (SME) on country / site management processes and works with their Area Head to facilitate the sharing of regional/ country intelligence /expertise and best practices within cross functional lines as needed.

Relationship Management

As applicable, act as the PRD representative on Country Medical Councils to ensure transparent communication within relevant Pfizer stakeholders in the cluster/country.

Ensure a proactive relationship is maintained between GSSO colleagues and other in-country functional lines such as regulatory, safety and medical affairs.

Proactively manage the relationship with other functional lines within GSSO/PRD e.g., study start-up (SUPM, CTA, SAP, ICL,), regulatory/CTRO, Investigator Payment leads, OAQS, Patient recruitment and study management to drive successful portfolio delivery in-country.

Proactively manage the country relationship with local external stakeholders (e.g., investigators, regulators, ethics committees, pharma associations, etc.).

Develop relationships with the CROs/vendors locally in support of delivery of GSSO strategies.

Resource & Compliance Management

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.

Oversee and drive quality & compliance and goal related metrics for given country/ TA, including FSP management metrics. Provide status updates in order to manage progress proactively as needed.

QUALIFICATIONS / SKILLS

Education

Must be fluent in English and French.

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

Experience

Extensive knowledge (minimum 14 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.

Skills

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 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.

Availability to travel within the region and/or globally as required.

Agility to adapt to VUCA (Volatility, uncertainty, complexity and ambiguity)/evolving environment

ORGANIZATIONAL RELATIONSHIPS

Partners with local Medical Affairs and colleagues at country and regional level

Partners with Research and Development colleagues 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 OAQS, Patient Recruitment teams as needed

Partners with contracted organizations e.g., FSP monitoring, pCROs and 3rd party vendors as applicable

When necessary, represents GSSO as the single point contact for the country/cluster/region. This role is key in providing clinical development portfolio updates to country/cluster/region management.

Represents Pfizer in key external bodies in support of enhancing the Clinical Trial Environment at Country/Cluster/Regional Level.

Colleague should be based in France- Paris, in order to follow the LIFYD policy.

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

Égalité des chances & Emploi 

Nous croyons que des équipes diversifiées et inclusives sont essentielles à la réussite d'une entreprise. En tant qu'employeur, Pfizer s'engage à valoriser la diversité et l’inclusion sous toutes ses formes. Cette diversité se reflète également à travers les patients et les communautés que nous servons. Ensemble, continuons à bâtir une culture qui encourage, soutient et responsabilise nos employés.

Handicap & Inclusion

Notre mission est de libérer le potentiel de nos collaborateurs et nous sommes fiers d'être un employeur inclusif pour les personnes handicapées, garantissant ainsi l'égalité des chances en matière d'emploi pour tous les candidats. Nous vous encourageons à donner le meilleur de vous-même en sachant que nous apporterons tous les ajustements raisonnables pour soutenir votre candidature et votre carrière future. Votre expérience avec Pfizer commence ici !