Pfizer Ignite service collaborations expand the way Pfizer works together with biopharmaceutical partners (Partners) to advance innovative therapies. Pfizer Ignite offers unique differentiated service capabilities with global scale and capacity, industry leading speed and quality to quickly develop quality assets, and one-stop shop with expertise across the entire development lifecycle.
The Pfizer Ignite Clinical Study Team Lead (iCSTL) leads the Pfizer internal study team and serves as main point of contact between Pfizer Ignite Scientific Services & Operations and the CRO/Vendor for fully outsourced clinical studies executed on behalf of Pfizer Ignite Partners (biotech companies).
Role Expectations, Accountabilities and Responsibilities include:
- Clinical Development expert focused on team leadership in early planning and set up, the oversight of clinical studies execution in partnership with Pfizer preferred Clinical Research Organization (CRO)/Vendor responsible for the operational management of Pfizer Ignite clinical studies and team leadership of appropriate study reporting.
- Brings deep industry expertise to the design, conduct and oversight of Pfizer Ignite clinical studies in alignment with the broader business development/ portfolio strategies for Therapeutic Areas (e.g., Oncology).
- Single point of accountability for quality oversight of the CRO/ Vendor deliverables related to the execution of Pfizer Ignite Studies.
- Responsible for providing input into study design to ensure feasibility of execution, planning and delivery of clinical studies on time, with high quality and within the approved budget.
- Experienced project manager and matrix leader accountable for leading and overseeing internal and CRO/Vendor study team delivery of multiple complex global Pfizer Ignite clinical studies.
- Responsible for developing and overseeing Pfizer Ignite clinical study timelines and budgets, including risk awareness and mitigation.
- Partners and collaborates with Pfizer and CRO/Vendor functional line leadership to ensure optimal resourcing of the study team and high team health.
- Responsible for overseeing and enabling proactive risk management and inspection readiness for Pfizer Ignite clinical studies under their remit.
- ROLE RESPONSIBILITIES
Additional responsibilities include:
- Oversees the execution of appropriate data and document delivery plans at key milestones, in alignment with contractual agreements with biotech companies/ clinical study sponsor, including interfacing and leading team in Governance interactions where necessary.
- Oversees operational and quality metrics across Pfizer Ignite studies to identify and manage trends and escalations. Partners with Pfizer Ignite, Research & Development (PRD) and Oncology Research & Development (ORD) leaders to assess study timelines and budgets, to inform the assessment of ongoing and future opportunities for the category and Pfizer Ignite partners, supporting continuous improvement activities.
- Provides quality oversight of the CRO/Vendor and of the CRO/ Vendor deliverables related to the execution of Pfizer Ignite Studies, including risk awareness and mitigation and issue management, escalation, and resolution (with appropriate cross-functional lines, as necessary).
- Ensures CRO/vendors have appropriate information and awareness of Ignite study, Sponsor, expectations, and any emerging information.
- In support of Ignite Operational Lean, ensures appropriate information (including risk) is readily available to meet Sponsor requirements, working with Ignite Project Team Assistant (IPTA) where appropriate.
- Monitors CRO/Vendor contracts for out-of-scope activities and budget spend/invoices for assigned vendors.
- Supports Quality Assurance Audits and Regulatory Inspections (e.g., Pfizer, Pfizer Ignite Partner/ study sponsor), CRO/Vendor audits) and Pre-Qualification Assessments of Pfizer and of the CRO/Vendor by the Pfizer Ignite Partner/ study sponsor), including accurate record-keeping.
- Supports the development of contractual agreements related to the clinical development services provided to Pfizer Ignite Partner/ study sponsor (e.g., scoping, Task Ownership Matrix).
- Serves as back-up for other iCSTLs and Pfizer Ignite Operational Leads as part of Pfizer Ignite's business contingency plan. Serves as back-up for PRD & ORD CSTLs accountable for Pfizer-sponsored clinical studies, as appropriate.
- Appropriate interactions with Pfizer Ignite Partner/study sponsor, ensuring information is shared in collaboration with Ignite Operational Lead and aligned with contractual obligations.
- Work with appropriate PRD and ORD colleagues to ensure lessons learnt and best practices are shared and applied.
- Study Team Leadership
- Supports the Pfizer Ignite Onboarding for internal and external clinical study team members.
- Responsible for managing and driving overall study timelines, budgets, and quality targets to meet or exceed business needs.
- Responsible for the transfer of Pfizer authored essential documents to the CRO/Vendor Trial Master File.
- Attends investigator meetings.
- Ensure timely close-out of Pfizer Ignite Studies including decommissioning of data & document sharing platforms, overseeing the transfer of study documents from Pfizer to the CRO/ Vendor Trial Master File (TMF) and final TMF transfer to the Pfizer Ignite Partner.
- Ensures necessary Pfizer systems are maintained and appropriate.
- Participates in Pfizer Ignite Strategic Projects, as appropriate.
- Bachelor's degree in one of the disciplines related to drug development or business required; advanced degree desirable.
- Extensive clinical studies conduct, global clinical studies operations, and a thorough understanding of the processes associated with project and study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations.
- Extensive experience in clinical study and/or vendor oversight.
- Ten or more years of relevant experience.
- PREFERRED QUALIFICATIONS
- Broad experience in a Clinical Study Execution discipline (e.g., senior study management expertise, lead data management expertise, clinical leadership expertise)
- Demonstrated project management and cross-functional leadership experience.
- Track record of leading virtually and without authority.
- Ability to develop and maintain strong and successful working relationships to enable fit-for-purpose study and CRO/vendor oversight.
- Experience in understanding of key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget.
- Experience in the development and management of CRO/Vendor oversight plans.
- Strong communication and interpersonal skills
- Ability to understand and assimilate high-level data from all clinical team functions.
- Strategic thinking and targeted problem-solving skills.
- Ability to (virtually) lead cross-functional teams, identify, resolve & escalate issues.
- Ability to champion the customer (internally and externally).
- Ability to leverage negotiation and conflict resolution skills to enhance team performance and delivery.
- Ability to represent & communicate clearly to senior leaders and governance bodies.
- NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Office-based position with significant (25-35%) business travel for team / site/ study sponsor / CRO/Vendor meetings.
- Establishes objectives, goals and plans for own activities.
- Meetings outside of standard working hours may be required to accommodate a global internal and external team.
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.
The annual base salary for this position ranges from $161,600.00 to $269,400.00. 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.
Relocation assistance may be available based on business needs and/or eligibility.Sunshine Act
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