Clinical Study Team Lead

JOB SUMMARY .

· Clinical Development expert focused on the execution of clinical studies and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies)/Therapeutic Areas.

· Single point of accountability for input into study design to ensure feasibility of execution, planning and delivery of clinical studies on time, within the approved budget and with quality.

· Experienced project manager and matrix leader accountable for leading the study team delivery of multiple complex global studies and/or programs.

· Responsible for developing and overseeing clinical study timelines and budgets. · Partners and collaborates with functional line leadership to ensure optimal resourcing of the study team.

· Responsible for proactive risk management and inspection readiness for their clinical study(ies). Your responsibilities may also include:

· Ensures comprehensive operational input to submission plan.

· Lead the delivery of Module 2/5 deliverables to support market authorizations including leading cross functional Module 2/5 submission sub- teams with accountability for overall operational strategy.

· Develops and leads execution of the data and document delivery plans at key milestones such as POC, DP3 decisions, submissions, and rapid response.

· Manages other submissions activities as necessary.

· Accountable for managing overall submission CD&O sub-team timelines, budgets, and quality targets.

· Accountable for building, forecasting, and managing the CD&O submission budget.

· Oversees operational metrics across submission sub-teams and manages trends and escalations.

· Work at the program level; at the program level the CSTL is accountable for developing the execution strategy and managing the timelines, budgets, and quality across multiple studies in the program.

DESCRIPTION:

· Provides quality oversight to the Clinical Research Organization (CRO) and of the CRO deliverables related to study execution.

· Leads and coordinates the execution of a clinical studies from Sourcing Strategy and Study Specification development for Requests for Proposals, Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data.

· Provides input to and supports compilation of sections to Clinical Study Reports and provide program-level insights. Provides leadership to the teams in the setting of realistic recruitment targets and delivery milestones.

· Monitors CRO and vendor contracts for out-of-scope activities and budget spend/invoices for assigned vendors.

· Provides centralized Pfizer Oversight to fully outsourced studies.

· A member of the GPD due diligence team for business development opportunities. Partner with GPD leaders to assess development program timelines and budgets to inform the assessment of opportunities for the category. JOB

RESPONSIBILITIES

Study Team Leadership

· Leads the study team and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets, and quality targets to meet or exceed business needs. · Accountable to ensure effective study team scheduling, records, and communications in partnership with the CSTA.

· Accountable for strategic planning and decision making at the study level in line with program objectives.

· Accountable for issue resolution.

· Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross functional study team performance and accountable for effective study team operations and team health.

· Leads study team chartering and team health check process.

· Partners and collaborate with functional line leadership to ensure optimal resourcing of the study team.

· Represents the study team at appropriate medicine team and sub-team discussions.

· Escalates issues to Clin Ops Head when study team has been unable to resolve or adequately manage/mitigate.

Quality Oversight

· Drives the monitoring and remediation of quality metrics and completion of the remediation tracker.

· Drives functional lines to ensure inspection readiness.

· Maintains active awareness and appropriate escalation of all Significant Quality Events (SQEs) reported for study and ensures appropriate prioritization and management of events through to resolution. Study Metrics & Reporting · Acts as a single, authoritative source of study information and leads study level status reporting per organizational norms and expectations.

· Ensures systems are maintained with up-to-date program status, risks, and issues.

· Oversees operational metrics across study and partners with functional lines to manage trends. Risk Management

· Leads the study team in the management and communication of risk management plans including risk assessment and mitigation strategies.

· Proactively identifies operational issues and leads the team in identifying options to de-risk and capitalize on opportunities.

· Ensures study risk planning is ongoing throughout the study.

· Leads the study team in proactive problem solving and risk management.

Governance & Decision Points

· Drives the proactive planning to navigate the team through governance and decision point milestones to support on-time delivery of study deliverable on-time to maintain development timelines. · Leads preparations for and presents the study to relevant governance per organizational norms and expectations.

QUALIFICATIONS / SKILLS

· Extensive clinical studies conduct, global clinical study 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

· Bachelor’s degree in one of the disciplines related to drug development or business required. Advanced degree desirable

· Preferred 10 or more years of relevant experience. Prior Experience Preferred:

· 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.

· Experience in understanding of key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget

Skills:

· Strategic thinking and targeted problem-solving skills.

· Ability to lead cross-functional teams, identify, resolve & escalate issues.

· Project management expertise.

· 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.

· Ability to understand and assimilate high-level data from all functions.

· Strong communication and interpersonal skills.

Work Location Assignment: Hybrid - need to be on site an average of 2.5 days per week

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

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

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