Clinical Pharmacology Study Team Lead (Sr. Manager)
- Employer
- Pfizer
- Location
- Remote, New York
- Salary
- Competitive
- Closing date
- Jun 17, 2021
View more
- Discipline
- Life Sciences, Pharmacology
- Position Type
- Full Time
- Job Type
- Manager
- Organization Type
- All Industry, Pharma
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ROLE SUMMARY
The Clinical PharmacologyStudy Team Lead (CPSTL) will lead and manage the cross functional study team and is the single point of accountability for the operational delivery of one or more clinical studies from concept through reporting, including inspection readiness, submission and regulatory defense.
The CPSTL is an expert on the operational delivery of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies). The CPSTL will be responsible for developing timelines and budgets for their clinical studies and leading the execution of these studies according to time, cost and quality targets.
The CPSTL is responsible for proactive operational risk management for their clinical study(ies). This role will be accountable for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health.
Cross-functional team leadership of clinical trial delivery:
Drive operational delivery at the study level and across studies:
Leads the study team to manage risk mitigation strategies including:
May perform some program level additional responsibilities.
Prior Experience Preferred:
Skills:
#LI-PFE
#LI-REMOTE
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.
Medical
#LI-Remote #LI-PFE
The Clinical PharmacologyStudy Team Lead (CPSTL) will lead and manage the cross functional study team and is the single point of accountability for the operational delivery of one or more clinical studies from concept through reporting, including inspection readiness, submission and regulatory defense.
The CPSTL is an expert on the operational delivery of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies). The CPSTL will be responsible for developing timelines and budgets for their clinical studies and leading the execution of these studies according to time, cost and quality targets.
The CPSTL is responsible for proactive operational risk management for their clinical study(ies). This role will be accountable for planning and delivery to the Best-in-Class targets as well as optimal resourcing of the study team(s) and ensuring optimal study team(s) health.
Cross-functional team leadership of clinical trial delivery:
- Single point of accountability for delivery from vendor selection through CSR/submission
- Accountable for managing overall study timelines, budgets and quality targets for an individual protocol / program
- Ability to lead and manage in an ambiguous, dynamic environment
- Responsible for cross-functional team communication and effectiveness
- Develop and maintain positive team dynamics and health
- Disciplined project and risk management approach
- Overall operational responsibility of clinical trial from study concept in development planning to submission/defense
- Provides operational strategy for program/protocol development
- Provides high quality study information to support timely decision making
- Accountable for building, forecasting and managing the Clinical Trial Budget for the program
Drive operational delivery at the study level and across studies:
- Establish and charter the study team
- Lead the study team in achieving goals & milestones manages, facilitates and documents core study team meetings (e.g. meeting agendas & minutes, action logs and decision logs)
- Accountable for delivery to improved cycle times metrics
- Facilitate effective decision making
- Lead the team in managing issues and problem solving
- Demonstrate Leader Behaviors in motivating and supporting the study team
- Ensures execution against study plan
- Manage critical changes and/or variance in financial forecast, schedule scope and deliverables
Leads the study team to manage risk mitigation strategies including:
- Identifying study level opportunities and risks
- Preparing, maintaining, and implementing risk mitigation and contingency plans
- Ensures progression of SQEs and resolutions
- Ensures cross-functional awareness, buy-in and agreement to risk/opportunities, action plans and resolution
- Ensures all key stakeholders / senior management are informed of study/program level major risks/opportunities and corresponding contingency /mitigation plans.
- Ensures communication and integration of study level risks/opportunities at the program level
- Responsible for coordinating, managing, and maintaining Inspection Readiness documents according to GSOP requirements (maintaining Study Team Roster, Vendor List, Systems List, Decision Log, SOP Log)
May perform some program level additional responsibilities.
- Represent clinical operations on the asset level teams
- Lead clinical operations' sub-team(s) where appropriate, in accordance with the organizational expectations and asset team charter
- Establish and ensure adherence to operational standards and best practices for the asset or program
- Manage and deliver to timelines, budget and quality for all studies in a program
- Interface with the GCL and program level roles including at the CRO
- BS - minimum of 8 years relevant experience
- MS/PhD - minimum of 7 years relevant experience
Prior Experience Preferred:
- Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, lead data management expertise, clinical leadership expertise)
- Demonstrated project management / leadership experience
- Experience in understanding of key drivers impacting budgets
- Experience in building a CTB and managing project to budget
Skills:
- Ability to lead cross-functional teams, identify, resolve & escalate issues
- Ability to represent & communicate clearly at Governances
- Ability to understand and assimilate high-level data from all functions
#LI-PFE
#LI-REMOTE
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.
Medical
#LI-Remote #LI-PFE
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