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Clinical Study Team Lead

2 months ago

New York City, United States Pfizer Full time

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.

ROLE SUMMARY

As a Clinical Study Team Lead (CSTL), you will be an integral member of Pfizer's clinical development team and a matrix leader accountable for study team delivery of multiple complex global studies and/or programs. Your clinical development expertise in the execution of clinical trials will enable contributions to the design and conduct of clinical studies in alignment with the program and portfolio strategies for the Internal Medicine, Anit-Infective, and Inflammation & Immunology Therapeutic Areas. Your project management skills will be leveraged to develop clinical trial timelines and oversee budgets for the assigned clinical studies/programs. Your ability to partner and collaborate with functional line leadership will be instrumental in ensuring optimal resourcing of the study teams. While managing complex project environments, you will anticipate potential project risks and influence teams to develop proactive risk management and inspection readiness plans. In this role, your strong leadership skills and clinical operations expertise will help make Pfizer ready to achieve new milestones and help patients across the globe.

ROLE RESPONSIBILITIES

Study Team Leadership

  • Lead study teams 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 for strategic planning and decision making at the study-level in line with program objectives

  • Represents the study team at appropriate medicine team and sub-team discussions

  • Partner and collaborate with functional line leadership to ensure optimal resourcing of the study teams

  • Drive functional lines to ensure inspection readiness; ensure maintenance and accuracy of Standard Operating Procedures (SOP) log

  • Maintain active awareness and appropriate escalation of all Significant Quality Events (SQEs) reported for study and ensure appropriate prioritization and management of events through to resolution

  • Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team performance and be accountable for effective study team operations

  • Accountable for issue escalation and resolution

  • Lead study team chartering and team health check process

Governance & Decision Points

  • Drive proactive planning to navigate the team through governance and decision point milestones to support on-time delivery of study to maintain development timelines

  • Develop and lead execution of data and document delivery plans at key milestones such as Proof of Concept and Phase 3 decisions

  • Lead preparations for and present the study to relevant governance per organizational norms and expectations

Risk Management

  • Proactively identify operational issues and lead the teams in identifying options to de-risk and capitalize on opportunities

  • Lead the study teams in proactive problem solving, management and communication of risk management plans including risk assessment and mitigation strategies

Study Metrics & Reporting

  • Act as a single, authoritative source of study information and lead study-level status reporting per organizational norms and expectations; ensure systems are maintained with up-to-date program status, risks, and issues

  • Oversee operational metrics across study(-ies) and partner with functional lines to manage trends

  • Accountable for managing overall submission of Clinical Development & Operations sub-team timelines, budgets, and quality targets

Submissions

  • Ensure comprehensive operational input to submission plan

  • Lead cross functional Module 2/5 submission sub-teams with accountability for delivery and overall operational strategy to ensure data and document delivery to support submissions and rapid response. Manage other submission activities as necessary

  • Oversee operational metrics across submission sub-teams and manage trends and escalations

BASIC 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

  • 10+ years of relevant experience (prior clinical trial, non-interventional study and/or epidemiologic study)

Prior Experience:

  • Extensive experience in conduct and operations of multiple clinical trials with compounds in development for indications in Internal Medicine, Anti-Infectives, or Inflammation & Immunology 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 and cross-functional leadership experience associated with project and study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations required

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

  • 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 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

  • 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

PREFERRED QUALIFICATIONS

  • Advanced degree

Relocation support available

Work Location Assignment:On premise (flexible with office location)

#LI-PFE

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.

  • The annual base salary for this position in Tampa, FL ranges from $145,400.00 to $242,400.00.

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.

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