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The Director of Site Activation Partners is accountable, from Site Selection, for delivering high quality, timely and cost effective Investigative Site Initiation and Activation Processes, at targeted sites, in accordance with applicable prevailing laws, Good Clinical Practices (GCP) and Pfizer standards. This is a strategic role that coordinates cross functionally to provide input to and to execute the investigator site strategy critical startup activities.The Director of Site Activation Partners will develop and maintain an organization of up to 50 individuals globally to ensure effective end-to-end document identification and collection processes, utilizing appropriate technologies, as required, to deliver best in class Site Initiation performance at targeted sites. They will partner with Study Start Up Project Management to implement effective Investigative Site interactions enhancing Pfizer's reputation and enabling its objective to be the development partner of choice.This role will leverage country intelligence and expertise to remove road blocks to timely Site Initiation by calling upon subject matter experts (e.g., Budgeting and Contracting, Site Care Partners ) and to remediate issues and apply continuous improvement principles to proactively prevent recurrences. This role will also serve as a point of escalation for Study Teams including offering options for mitigation (both at the study and site level) on the trials Site Initiation.The Director of Site Activation Partners will understand and support Pfizer's targeted investigator site strategy and will enable a strategic relationship and approach to collaborate closely with those critical institutions. They will look to align and harmonize the appropriate processes at an Institutional level in order to enable consistently rapid Site Initiation across the Pfizer portfolio.
Responsible for providing strategic leadership to enable High Quality, Timely and Cost Effective Site Initiation and ongoing maintenance of critical documents for targeted sites.
Responsible for providing strategic input into the investigator site strategy.
Build and maintain a Site Initiation (Ethics/IIP) Regulation and Requirements intelligence network informed by local knowledge and expertise.
Establish and evolve Key Performance Indicators and local country Cycle Times; understand baseline performance, set meaningful targets and adapt the Site Initiation processes to ensure achievement of Pfizer's Best in Class objectives (quality, speed and cost).
Leverage Site Care Partners , as appropriate, to remove Site Initiation roadblocks. The Director of Site Activation Partners acts as an escalation point for the Investigator Site.
Develop and operationalize delivery of the Site Activation Partner role to support the Targeted Site Strategy, through collaboration with other leaders, using a flexible resourcing model.
Leverage continuous improvement principles to drive industry leading performance.
Identify (e.g., through trends), share, and implement best practices; ensuring consistency in end start up processes & systems, and site documentation maintenance.
Provides leadership to staff to ensure their understanding of overall CD&O strategy, culture, vision, goals and other information relative to operations activities.
Strategic Site Initiation Strategy for Targeted Sites:
Collaborate across GSSO (e.g., with Targeted Investigator Network Strategy Implementation Lead and Site Care Partners ) to understand and proactively contribute to Targeted Investigator Sites Strategies.
Collaborate with other Pfizer stakeholders (e.g., Contracting and Budgeting) to align on a consistent / portfolio level engagement model.
Ensure that Site Activation Partners leverage an Institution level focus to targeted Investigator Sites and that Site Initiation learnings from individual studies are applied for future studies.
Understand Targeted Site initiation tools and processes. Develop strategic and tactical plans to streamline the way in which Pfizer operates with these partners (e.g., technology, relationship or process refinements) in order to ensure consistently rapid Site Initiation delivery.
Collaborate with the Site Care Partners to ensure expedited resolution of any Site Initiation issues.
Stakeholders:
Collaborate extensively, in country and globally, with Regulatory Operations, especially the Clinical Trial Application (CTA) Lead, as well as with the Site Care Partners , Study Optimization and with Clinical Supplies to ensure timely Site Initiation and activation, as well as appropriate lifecycle maintenance.
Also collaborate with the Process, Standards & Signal Interpretation Group Lead, to analyze trends and facilitate improvements to Site Initiation Processes and Technologies. Drive cross functional alignment of senior stakeholders in Regulatory Operations, Study Optimization, Clinical Supplies, and across GSSO to align to a site initation strategy that delivers industry leading performance
BASIC QUALIFICATIONSA Bachelor's degree is requiredPREFERRED QUALIFICATIONSAn advanced degree (MS, MBA, PhD) is preferred.In general, candidates for this job would hold the following levels of education/experience:
10+ years related experience, including at least 7 years in a large international corporation
Proficiency in English required, an additional language is an advantage if aligned to the targeted investigator strategy
People management including recruitment, retention, coaching, career development and performance management
Leadership, project/resource management (project, staff, finances)
Experience of organizational change including development, principles, and associated successful implementation
Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict
EEO & Employment EligibilityPfizer 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.Sunshine ActPfizer 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.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical
Vacancy expired!