Clinical Study Group Lead

Why Patients Need You
Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.
Join us, and be a part of a team that values innovation, collaboration, and the relentless pursuit of excellence. Together, we can lead the way in healthcare and make a lasting impact on society.
What You Will Achieve
As a Clinical Study Group Lead, you will be an operational and clinical development leader accountable for delivery of your assigned portfolio comprised of multiple, complex 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 execution of clinical trials will enable contributions to the design and conduct of clinical studies in the respective Therapeutic Area(s). You will ensure appropriate operational contributions are provided to governance committees relating to clinical study operations and submissions. You will be accountable for Clinical Operations leadership of Module 2 & 5 submission subteams and endgame inspection readiness. In the Clinical Study Group Lead role, you will be responsible for talent development and supervision of Clinical Study Team Leads (CSTLs) in your group along with mentoring and coaching CSTLs on best practices - in alignment with the Clinical Operations Head's strategy. You will also be responsible to ensure the CSTLs are effectively leading the studies through the various stage gates of development (i.e. First in Human/ First in Patient, Proof of Concept, Decision Points, Quality Gates, etc.). You will also oversee the management and driving of overall study timelines, the quality and accuracy of data inputs for reporting on study performance, budgets and quality targets to meet or exceed business needs. Your ability to collaborate cross-functionally and leverage relationships across divisions will be instrumental in ensuring optimal resourcing of the study teams. Your ability to anticipate potential project risks, exercise foresight and judgment in initiating, planning, organizing and guiding complex projects will help make Pfizer ready to achieve new milestones and help patients across the globe.
ROLE RESPONSIBILITIES
Portfolio Operational Leadership

• Accountable for operational strategic planning and delivery of 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 subteams with accountability for overall operational strategy and delivery of data and documents in support of submissions and rapid response
• Accountable for endgame inspection readiness for assigned portfolio
• Responsible to ensure adequate resourcing for projects in assigned portfolio

Clinical Operations Line Management

• Support CSTLs to address emergent issues and ensure rapid communication of critical issues to Clinical Operations Head as appropriate
• Responsible for the identification, selection, development, performance management, mentoring/training, retention and engagement of a group of up to 15 CSTLs.
• Accountable to ensure 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
• Potential to work at the program/asset or study level if needed and assume CSTL responsibilities, such as development of the operational strategy, 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 CSLTs 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 PRD initiatives and pan-Pfizer initiatives for the relevant TA

QUALIFICATIONS
Training and Education

• Bachelor's degree (BS/BA) in science, health-related field or epidemiology, or a discipline related to drug development or business required
• PhD, PharmD, M.S. or other professional certification preferred

Prior Experience and Capabilities

• Minimum of 13-years 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
• 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 problem-solving skills
• Exceptional communication and interpersonal skills
• Ability to lead cross-functional 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 high-level data from all functions and proven scientific writing skills

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.
Relocation support available
Work Location Assignment: Hybrid
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The annual base salary for this position ranges from $191,300.00 to $341,100.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 22.5% 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.
* The annual base salary for this position in Tampa, FL ranges from $184,200.00 to $307,000.00.
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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