Director of Study Management

The Director of Study Management will provide strategic Therapeutic Area (TA) and program level contributions such as input to development plans and program-level strategies for Study Management. They may assume responsibility for delivering a portfolio of assets or compounds. They will provide managerial oversight to study management colleagues in their respective groups and their associated deliverables within and across that portfolio. The Director of Study Management is responsible for talent development of colleagues, preparing Study Managers to deliver on studies. They are accountable to ensure all assigned direct reports are appropriately trained. They are accountable to ensure Study Managers are following Pfizer Standard Operating Procedures (SOPs) and providing leadership and appropriate oversight to the Contract Research Organizations (CROs). They are accountable to ensure that Study Managers are delivering according to agreed plans and to ensure appropriate proactive escalation of risks and deviations to plans, and that any asset level strategies are appropriately implemented. The Director of Study Management will define and leverage performance data, e.g. operational metrics, study plan variance and trend reports to drive the business and support the oversight and management of both the Study Managers and CROs. They will also interface with CRO managers to resolve issues and escalate resource concerns. The Director of Study Management is a Subject Matter Expert (SME) on study management processes and works with their Study Management Group Lead (SMGL) to facilitate the sharing of therapeutic/functional area expertise and best practices within their group and where applicable across the Study Management organization. They may sponsor, lead or represent Study Management on cross-functional cross-departmental or enterprise level work streams that influence senior management and have an impact on business direction. The Director of Study Management will have responsibility for delivery of an asset or assets within their portfolio. They will interface with various stakeholders across the organization including but not limited to Clinical Study Group Leads, Clinicians and Global Clinical Leads, Data Management Group Leads and DCSOs to ensure appropriate issue resolution/escalation and healthy stakeholder relationships. They will also interface with the stakeholders within study management and monitoring functions at the CROs to ensure optimization of services. They are accountable for building and ensuring therapy/functional area expertise and technical study management expertise for their group of direct reports through recruitment and talent development/management of staff and the development of training strategies to enhance study management RESPONSIBILITIES: Line Management and Strategic Implementation May partner with Senior DSMs and Study Management Group Lead on defining & providing managerial leadership of strategies within group and specific implementation of processes, quality goals and standards Line Management of Study Managers Actively develops and retains talent through providing focused career development, performance management, and an inclusive culture Responsible for the development and adherence to consistent harmonized processes and high-quality clinical trial deliverables for clinical projects Create, maintain and assume accountability for a culture of high quality and customer service using tools to facilitate communication, transparency of operations, clarity of workload balance, and alignment within and across functional lines Support and continuously evaluate and evolve the Study Manager role to add value and efficiencies to internal study management Work with other cross functional lines to improve processes and important quality aspects of studies including site selection, recruitment and retention practices, Significant Quality Event (SQE) process, etc. to simplify processes and ensure quality in the studies Responsible to ensure Study Management elements are considered as part of the whole of the Operational Strategy across as asset/program by working with Clinical Study Group Leads, Global Clinical Leads and Asset Leads as needed. Study Management Sourcing and Oversight Works with sourcing partner/ resourcing lead to ensure provision of technically trained Study Managers per sourcing strategy The DSM will interface with the Clinical Study Group Leads and CSTLs as applicable for issue escalation, SM performance issues and to discuss resource demand and for specific study resource requests Contributes to the Study Startup, Study Monitoring & protocol recruitment plans of linked studies within an asset/program Inputs and reviews SMPs within Asset assignment to ensure consistency and excellence Supports study/program level submission readiness Study Team and other Interfaces Subject Matter Expertise: In strong collaboration with other colleagues or functions (peers, project leads, and group leads): Leads cross departmental initiatives Implements strategies to ensure consistent processes Leads and/or participates in specific process improvement initiatives; monitors and reports on implementation progress as appropriate Provides expertise on the study management related SOPs and serves as a Study Management SME on BPIs and SOP development/update projects.  Proactively shares best practices across CD&O. Works with SMGL and GSSO Resourcing and Outsourcing Lead to ensure provision of technically trained Study Managers per sourcing strategy The DSM may assume Asset-Level responsibilities within their assigned portfolio taking accountability for delivery of studies conducted under that program QUALIFICATIONS Training and Education Extensive global clinical trial/study management experience Working knowledge of GCPs, monitoring, clinical and regulatory operations BS – minimum of 14 years relevant experience MS/PhD – minimum of 9 years relevant experience Prior Experience Experience in the management and direct supervision of internal resource Demonstrated effectiveness working in a multidisciplinary, matrix team environment Direct study management expertise Experience of resource management (staff and financial) Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend Evidence of Clinical Development and pharmaceutical study execution experience Skills Ability to understand and assimilate high-level data and operational metrics and trends Strategic thinking and targeted problem-solving skills Maintains scientific/operational knowledge and expertise to possess credibility to discuss with higher level management and peers Strong interpersonal skills Establishes strong relationships with customers, strives to understand and meet customer requirements Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures; motivates through example, commitment, loyalty and enthusiasm Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization Creativity and/or ability to put innovative approaches into practice in clinical development PREFERRED QUALIFICATIONS Thorough understanding of Clinical Development and pharmaceutical study execution experience; thorough understanding of the processes required to operationally execute clinical trials Experience in therapeutic / functional area of expertise Evidence of strong leadership, influencing, negotiation, and management skills Hybrid Role - must be on-site 2-3 days/week #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. 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 Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Salary : $161,600 - $269,400