The Governance Senior Manager provides leadership and expert guidance for governance and clinical excellence activities across the Governance and Clinical Excellence group. This role has primary accountability for the Study Review Committee (SRC) governance review processes under CT02, CT45 and CT19 SOPs, and is responsible for shaping the governance framework that supports high quality protocol, operational plan, and RQP reviews.
The Senior Governance Manager drives continuous improvement, oversees the design and implementation of SRC metrics, and ensures governance systems operate with efficiency, compliance, and transparency. This role provides strategic partnership to governance leadership, Business Process Owners (BPOs), clinical teams, and cross functional stakeholders. The position also leads complex governance initiatives, manages largescale process improvements, and influences enterprise wide standards.
JOB RESPONSIBILITIES
Indicate the primary responsibilities critical to the job.
Responsibilities for include but are not limited to the following:
Scope of Responsibility and Team Influence:
* Provides leadership to the R&D SRC governance process, ensuring consistent endorsement of protocols, operational plans, and RQPs across programs and therapeutic areas.
* Oversees and shapes the SRC metrics collection and reporting, including development, refinement, and interpretation of metrics used to evaluate compliance, quality trends, and process optimization opportunities.
* Leads resource and technology planning across governance systems such as the Governance Navigator and PleaseReview, anticipating organizational needs and preparing for future capacity demands.
* Provides oversight to the Navigator System, ensuring prioritization, scheduling, and reviewer allocation optimize efficiency and quality across governance pathways.
* Applies advanced project management, change‑leadership, and continuous improvement methodologies to drive governance excellence.
* Establishes governance communication standards and ensures effective stakeholder engagement across clinical teams, boards, and functional partners.
* Oversees complex administrative and operational processes associated with SOP process, ensuring standardization and timely execution, supports the CT05 and CT40 BPOs with day-to-day process work
* Supports other governance staff, guiding execution of governance‑related analyses, metrics, and process enhancements.
Knowledge and Skills
* Recognized internal expert in continuous improvement, clinical governance models, and operational excellence.
* Knowledge of clinical development processes, project management methodologies, and governance frameworks.
* Serves as a technical and strategic resource, advising clinical and operational stakeholders on governance best practices, including CT05 and CT40 SOP knowledge to facilitate BPO support
* Applies understanding of internal and external clinical landscape to anticipate risk, identify opportunities, and drive enhancements to governance models.
* Champions innovative approaches and data analytics to elevate governance efficiency and maximize business value.
Decision Making and Autonomy
* Review launches and closures: troubleshooting of document issues with SME to ensure timely and quality review cycles. Guides teams to support documentation for launch, closure, and response distribution and working with Business Technology SMEs to support functionality
* Exercises significant autonomy in shaping governance process and metrics that may require developing new options to resolve complex problems such as governance portal updates and governance metrics development
* Makes decisions guided by clinical trial and study management policies in unusual or atypical situations, able to operate independently in ambiguous situations related to governance process, e.g. expedite joint DRC/SRC reviews
* Makes strategic decisions influencing multiple clinical programs, governance workflows, and delivery timelines with impact on the work of multiple clinical study, program teams and business units
* Exercises own judgment utilizing breadth of knowledge and prior work experience to implement metrics for continuous improvement. May become a resource for others
* Mostly reviews own work, solicits directional review from others such as the Governance Lead and Governance Head and may review work completed by other colleagues when acting in a mentor role
Leadership
* Leads governance wide strategic initiatives, including major enhancements to the Governance Navigator and governance platforms.
* Develops communications, presentations, and governance summaries for senior leadership and committees.
* Provides coaching and development for governance colleagues; may lead or oversee a sub‑team responsible for metrics or process improvements.
* Employs diverse communication methods, including email, MS Teams, and newsletters, to effectively explain complex concepts when interacting with study teams and board members.
* May take a leadership role during meetings to facilitate agreements and move the team toward its goals. Takes responsibility for a portion of the team's milestones and deliverables, may lead a metrics or process team
* Leads the implementation and testing of additional Navigator requirements and releases in collaboration with BT
* Leads development of presentations, newsletters, and communications for study teams and Board members as needed.
QUALIFICATIONS / SKILLS
BASIC QUALIFICATIONS
* Bachelor's Degree in a biomedical discipline
* 10 or more years pharmaceutical industry experience.
* Continues Improvement qualification (e.g. Lean Six Sigma) or other post-graduate qualification
* Proficient-level user of technology found in the corporate environment, including but not limited to Microsoft Teams/SharePoint, Microsoft Excel, Microsoft PowerPoint, Word
* Understanding of how the external environment can influence internal strategy and implementation.
PREFERRED QUALIFICATIONS
* Good knowledge of GCP, clinical development, study execution including Protocol Deviation, Informed Consent and protocol writing
* Experience in more than one clinical development discipline, e.g. Clinical Development, Project Management, Statistics, Pharmaceutical Sciences, Drug Safety, Medical Writing.
* Experience with Clinical development, including protocol design, creation, content and execution.
PHYSICAL/MENTAL REQUIREMENTS
Candidate should thrive in a dynamic, global, senior leadership setting.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
As this is a global role, some work outside usual working hours may occasionally be required to accommodate other time zones.
Occasional travel to governance group meetings may be required (<5%).
Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed.
The annual base salary for this position ranges from $116,000.00 to $187, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% 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 | ). 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
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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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Continuous Imprv and Proj Mgmt