Site Organization Oversight Lead

Job Summary
The Optimization, Analytics & Recruitment Solutions (OARS) team provides fit for purpose, robust intelligence and data insights designed to optimize performance of the Research & Development (R&D) engine providing analytics & intelligence to customers and stakeholders across clinical and regulatory functions within PRD & POD.
The Site Intelligence, Experience & Site Partnerships team is a combination of key site focused capabilities within a single, site centric group allowing for end-to-end delivery. This function spans, strategic site partnerships, Site Organization Management, Site experience, Regional Intelligence and Due Diligence. These functions create a unified experience from initial feasibility outreach through to trial closure, embed diversity practices into site services, enable site experience to work closely with operations, connects local intelligence and site outreach with site partnership development and ensures centralized Due diligence/Third Party Risk Management activities associated with Primary Investigators (PIs), Sub Investigators and entities.
The Site Organization Oversight Lead is responsible for leading activities ultimately to protect Pfizer from reputational risk resulting from the conduct of work / collaboration with HCP's and Clinical Trial Sites / Organizations throughout the lifespan of their potential work with Pfizer.
The role will manage specific third-party entities (e.g., Site Organizations) and be accountable for the establishment and oversight of operational and quality delivery by a third-party entity. The role will provide guidance and be a point of contact for escalation and issue management for study teams.
Job Responsibilities

• Maintain regular and proactive communication channels with Site Organizations, ensuring collection of both informal and formal performance metrics, and valuable feedback.
• Serve as a centralized point of contact for Site Organizations, facilitating seamless communication and issue resolution by liaising with appropriate teams and ensuring timely escalation of queries. Follow up on issues and effectively close the loop with SOs to ensure awareness and resolution.
• Continue to build upon the strategic site partnership strategy, where deemed business appropriate
• Help to implement a strategic enterprise roadmap based on curation of Site Organization information, to ensure they are fully scaled across the portfolio
• Implement a customer relationship management approach and scorecard for Site Organizations and strategic partners for continuous improvement
• Where assigned, a lead may monitor speed, cost and quality efficiencies gained ensuring strategies meet Pfizer's Early Clinical and Clinical Pharmacology portfolio demands, and will collaborate with the PCRU Organization in order to effectively utilize any existing consortium
• Review and oversee site practices that may deviate from Pfizer's established protocols and standards. Collaborate closely with study teams and management to address any discrepancies, ensuring adherence to Pfizer's guidelines and optimizing study execution.
• Manage the curation of all sites and investigators within a Site Organization (SO), ensuring comprehensive oversight
• Develop and maintain strong relationships with SOs through a centralized model approach, fostering collaboration and efficiency across multiple projects
• Ensure Diversity operational oversight across Site Organizations; monitor performance for ongoing/completed studies, and assess how Diversity is included as part of SOs plans within their organizations
• Evaluate Rate Cards and negotiate Confidentiality Disclosure Agreements (CDAs) and Master Service Agreements (MSAs) as required, ensuring favorable terms and compliance with company policies
• Act as a primary point of contact for relationship management, handling key issues and facilitating communications as required during the execution of studies
• Conduct entity qualification processes such as SO Intake Form or specific Pfizer processes as they adapt to this space, ensuring alignment with strategic objectives and operational standards
• Provide rigorous oversight of entities within the network, including conducting regular calls, maintaining proactive entity-level communications, and ensuring business continuity.
• Supports the Feasibility process to RFP select Site Organizations as appropriate
• Monitor partnership performance through Metrics and Key Performance Indicators (KPIs), delivering comprehensive Quarterly status updates and maintaining regular communication with internal teams at site-facing levels.
• Implement routine reviews of SO Intake processes to optimize efficiency and compliance with regulatory requirements.
• Lead and manageaudits within the Study Organization (SO), including coordinating responses to site audits and tracking Corrective and Preventive Actions (CAPAs) to timely closure.
• Participate in initiative-driven projects as required, contributing expertise and leadership to achieve program objectives and deliverables
• Collaborate closely with OARS and GSSO to facilitate the rollout and implementation of above study/Site Organization signals and metrics, conducting thorough assessments of learning gaps and identifying opportunities for enhancement.
• Work in partnership with stakeholders and functional departments (e.g., Quality, Process and Standards, GSSO) to ensure comprehensive understanding of study and site-level signals and metrics, while actively contributing to the identification of potential process improvements.
• Regularly evaluate and report on metrics performance to the Process, Standards, and Signal Interpretation Lead, GSSO and OARS LT teams providing valuable insights and recommendations for optimizing operational efficiencies
• Act as a primary business interface for the OARS analytics teams, offering essential business context and requirements for necessary metrics and data
• Support development as needed of Study SO/Site Network strategies, coordinating with the Disease Intelligence Analytics Lead (DIAL) and Feasibility Strategy & Analytics Lead (FSAL)
• Demonstrates ability to exhibit adaptive risk management and a learning culture by ensuring site quality and trends, including preventive actions are shared across other Site Organization Leads and teams across the portfolio to drive accelerated drug delivery.

Qualifications/Skills
In general, candidates for this job would hold the following levels of education/experience:

• A medical or scientific or technical degree in the healthcare field required.
• BS - 10-15 years relevant experience
• MSc/PhD - 10 years relevant experience

Prior Experience

• 10-15 years broad based experience of drug development, clinical trial conduct, global clinical trial operations, working knowledge of GCP and a thorough understanding of Pfizer processes and standards
• Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
• Demonstrated ability to develop and maintain strong customer and business partner relationships. Proven track record of managing business to business relationships with healthcare systems

Skills

• Demonstrate strong executive relationship building and influence and experience working with the C-suite within the healthcare industry
• Must be fluent in English. Local language capabilities are an advantage in this role and cultural awareness when working across regions/countries
• Conversant with the long-term strategy of the business and is able to leverage this in order to prioritize activities and answer key business questions
• Able to make complex decisions that require assessing and choosing amongst multiple options, amidst competing priorities, and in ambiguous situations, to timelines and with resource available
• Outstanding communication and interpersonal skills; results orientation, tenacity, and follow through with internal and external stakeholders
• Ability to systematically evaluate and prioritize multiple business opportunities within a TA and has strong business acumen
• Sufficient Therapeutic Area knowledge to allow for meaningful HCP discussions
• The ability to be successful in a matrixed environment with a high degree of flexibility; collaborate well across functions of PRD, POD and specifically Country and Site Operations. High degree of influencing skills.
• Must have a proven track record of being effective at self-management and driving results
• Ability to deal with high levels of ambiguity and proven ability to work in a fast paced and constantly changing environment.
• Data-driven with experience leveraging metrics, KPI's, and analytics to create accountability structures that drive success of the organization.
• Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk

Organizational Relationships

• Reports to Head Site Organization Oversight
• Partners with Business Process Owners, Finance, CD&O Business Operations and Procurement Groups
• Global Sites - Senior Executives and Investigators at Sites
• Quality/Compliance

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: Hybrid
The annual base salary for this position ranges from $149,200.00 to $261,000.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% 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.
* The annual base salary for this position in Tampa, FL ranges from $141,000.00 to $235,000.00.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Medical