Senior Director Clinical Site Operations (m/f/d)
Job Description
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Right now, we are seeking highly qualified candidates to fill the position:
Senior Director Clinical Site Operations (m/f/d)
About the role:
Reporting to the Head of Site & Country Operations, the Pfizer Oncology Division (POD) Senior Director of Clinical Site Operations (Senior DCSO) is a dynamic leader supporting the Head of Site & Country Operations to deliver their strategic vision and representing POD operations at the country or cluster level.
Represents POD at the country or cluster level playing a critical role 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/cluster.
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.
The Senior DCSO influences leadership decisions that impact business, will build and leverages constructive internal relationships within POD and PRD, to drive strategic initiative/success.
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/cluster 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.
The Senior DCSO may sponsor, chair, or lead operational strategic initiatives, to accomplish business objectives that are multifaceted and unique in complexity. Also encompassing and empowering an extensive team / line management, mentoring and coaching duties.
JOB RESPONSIBILITIES
The Senior 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 countries/clusters. This role provides line management and oversees the Site Care Partner and Site Monitor ensuring compliance with training requirements. The Senior DCSO is accountable to ensure overall monitoring, operational site partnership, management and oversight activities within a designated country/cluster 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. Senior 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/cluster budget in accordance with financial expectations.
Demonstrate leadership in the resolution of site/country/cluster issues to ensure project delivery, patient safety, quality and maintain investigator site relationships
This is a strategic role that 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/cluster.
The Senior 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/cluster 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 responsible for the communication of the future trial portfolio to appropriate country/cluster stakeholders.
Responsible for country level input into country selection, pre-feasibility, study design and siteidentification and selection and ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders.
The Senior DCSO will lead, contribute to, and implement strategic initiatives as a representative of the GSSO Leadership. Leading initiatives that shape the clinical development environment within their country/cluster 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 DCSO 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 (bothat the country/cluster and site level); collaborating with and informing stakeholders (e.g., study/program teams, localMedical 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.
When required, contribute to area or global GSSO strategy by leading and participating in area orglobal initiatives.
- The Senior 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 ensuretransparent communication within relevant Pfizer stakeholders in the cluster/country.
About You:
Basic Qualifications
Bachelor’s degree with 15+ years of pharmaceutical/Biotech clinical development experience
Master’s degree with 13+ years of pharmaceutical/Biotech clinical development experience
PhD/MD degree with 10+ 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
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
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 atcountry level.
Ensures close collaboration with country and/or regional managers/leadership and key globalstakeholders (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, ProjectPlanner, 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, and 3rd party vendors as applicable
When necessary, represents GSSO as the single point contact for the country/cluster/region. This role is k 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 atCountry/Cluster/Regional Level.
Requirements
Availability to travel up to 50% of time.
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