Senior Director, Clinical Site Operations

ROLE SUMMARY:

The Senior Director, Clinical Site Operations (DCSO) 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.

 

This Senior DCSO position will lead Centralized Platform Services in the US. This includes the Centralized ICD Team and Audit Coordination. They will influences top management decisions that impact business directives.

 

The Senior DCSO 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.

 

They will act as 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.

They may serve as delegate to the Area Head for certain key activities, initiatives, and deliverables.

 

ROLE RESPONSIBILITIES:

• The Senior Director, 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.

QUALIFICATIONS:

• BA/BS with at least 12 years of experience or MBA/MS with at least 10 years of experience or PhD/JD with at least 7 years of experience or MD/DVM with at least 5 years of experience
• People management experience
• Ability to lead and manage diverse teams
• Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities
• Ability to leadand influence in a matrix environment, capable of driving initiatives across GSSO
• Demonstrated understanding of HR procedure and policies at global and local level
• Ability to work effectively with line support functions including finance, HR 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

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment: Remote

The annual base salary for this position ranges from $204,700.00 to $341,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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