Clinical Study Group Lead Secondment - 12 Months

Why Patients Need You

This 12month secondment is open to colleagues with extensive clinical operations experience in Sickle Cell Disease clinical studies/programs. In the secondment role as a Clinical Study Group Lead you will be an operational and clinical development leader accountable for delivery of the Sickle Cell Disease assets and other assigned global programs and studies. You will partner with the Clinical Operations Head and other leaders in early and late phase development to generate innovative operational strategies that are aligned with the clinical development plans and advance the portfolio. Your clinical development expertise in the leadership and of clinical trials will enable contributions to the design and conduct of clinical studies in Sickle Cell Disease and other TA assets.

What You Will Achieve

You will ensure appropriate operational contributions are provided to governance committees relating to clinical study operations and submissions. Clinical Operations is accountable for leadership of Module 2 & 5 submission sub teams and ensure inspection readiness. In the Clinical Study Group Lead secondment role you will oversee Clinical Study Team Leads (CSTLs) on assigned studies mentor and coach them on best practices as per the Clinical Operations Heads strategy. You will ensure CSTLs effectively guide studies through the development stages like First in Human/ First in Patient Proof of Concept Decision Points Quality Gates. You will oversee management and driving of overall study timelines quality and accuracy of data inputs for reporting on study performance budgets and quality targets to meet or exceed business needs. Collaboration across divisions will be key for optimal team resourcing. Your foresight in identifying risks and guiding complex projects will help Pfizer achieve new milestones and help patients globally.

How You Will Achieve It

Portfolio Operational Leadership

• Accountable for operational strategic planning and delivery of Sickle Cell Disease and respective portfolio of assets or studies

• Accountable to deliver excellence in clinical study team leadership for a portfolio of clinical trials ensuring the trials progress in accordance with agreed clinical and operational plans

• Ensure appropriate operational contributions are provided to governance committees relating to clinical study operations and submissions

• Oversee management and driving of overall study timelines quality and accuracy of data inputs for management reporting on study performance budgets and data quality targets for assigned portfolio

• Provide single point of responsibility for partner lines and stakeholders for assigned portfolio

• Ensure CSTL leadership of Module 2/5 submission sub teams with accountability for overall operational strategy and delivery of data and documents in support of submissions and rapid response

• Accountable for inspection readiness for assigned portfolio

• Responsible to ensure adequate resourcing for projects in assigned portfolio

Clinical Operations Oversight and Coaching

• Support CSTLs to address emergent issues and ensure rapid communication of critical issues to Clinical Operations Head as appropriate

• Responsible for mentoring/training retention and engagement of a group of up to 6 CSTLs.

• Assist with ensuring assigned group of CSTLs possess appropriate team leadership functional and technical skills to enable successful leadership of the study teams

• Hold regular coaching and feedback sessions with CSTLs within group and maintains a diverse high performing team

• Develop & implement strategies to maximize competency in leadership and clinical project management and skills related to cross functional team leadership

• Work at the studylevel as needed assuming CSTL study responsibilities such as development of the operational strategy and leadership of study team(s)

• Potential for oversight of strategic drug development partnerships and/or clinical research collaborations along with business development and due diligence opportunities for the specific Therapeutic Area

Risk Management Quality and Process Improvement

• Ensure CSTLs proactively identify operational issues/risks and lead the study teams in development of risk management plans including risk assessment and mitigation strategies

• Instill a culture of continuous improvement; provide expertise and deployment of operations best practices across portfolio through facilitation of information sharing

• Contribute to R&D initiatives and panPfizer initiatives for the relevant TA

Qualifications

MustHave

Training and Education

• Bachelors degree (BS/BA) in science healthrelated field or epidemiology or a discipline related to drug development or business required.

• Minimum of 12years of experience and track record of success in biopharmaceutical industry in clinical operations or related disciplines

• 10 years of line management experience desired with demonstrated ability to manage and develop colleagues

Prior Experience and Capabilities

• Extensive experience in clinical operations leadership of studies/programs in sickle cell disease

• Extensive clinical trial conduct global clinical trial 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

• Experience with conduct of multiple clinical trials and clinical trial operations in Inflammation & Immunology therapeutic area strongly preferred

• Demonstrated project management experience

• Demonstrated experience in understanding key drivers impacting budgets building Clinical Trial Budgets and managing projects to budget

• Successful experience working with outside vendors contracted to perform clinical operations activities desired.

• Demonstrated 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

Skills

• Strategic thinking and targeted problemsolving skills

• Exceptional communication and interpersonal skills

• Ability to lead crossfunctional clinical/medical teams identify resolve and escalate issues

• Ability to influence and collaborate with peers

• Ability to leverage negotiate and resolve conflicts to enhance team performance and delivery

• Ability to represent & communicate clearly to senior leaders and governance bodies

• Ability to understand and assimilate highlevel data from all functions and proven scientific writing skills

NicetoHave

• PhD PharmD M.S. or other professional certification preferred

Other Job Details

• Last Date to Apply for Job:April 22 2025

• Eligible for Relocation Package NO

• Secondment 12 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for12 months or longer you will be required to turn in your fleet vehicle for the duration of the nondriving secondment. Please refer to the Fleet Policy and Procedures document for more information.

• Position is considered Flexible and colleagues are expected to comply with Log In For Your Day(LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

Relocation assistance may be available based on business needs and/or eligibility.