Director of Study Management

Use Your Power for Purpose

• The Director of Study Management will provide strategic Oncology therapeutic area and program level contributions to development plans and program-level strategies for Study Management. They will provide managerial oversight to study management colleagues in their respective groups. They be accountable for the end-to-end study management operational delivery, consistency, and quality across the studies within a program and/or asset within their portfolio.
• The Director of Study Management is accountable to ensure all assigned direct reports are appropriately trained, following Pfizer Standard Operating Procedures (SOPs), and are responsible for their talent development, preparing Study Managers to deliver studies. 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. They are accountable to provide leadership 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. Additionally, they will interpret and translate study-level data to identify risks to assess against overall risks to the asset.
• The Director of Study Management will interface with various stakeholders across the organization including but not limited to Clinical Study Group Leads, Clinicians, Clinical Group Leads, Global Development Leads, Clinical Data Scientist Program Leads, GSSO Group Leads, Area Heads, and DCSOs to ensure appropriate issue resolution/escalation and healthy stakeholder relationships. They will also interface with the Vendor Leads and leadership within the FSPs and CROs to ensure optimization of resources and services, drive progress across their assigned assets, and influence strategic direction for this partnership within their therapeutic area. They will also interface with FSP and 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 development of training strategies, 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 [1]departmental or enterprise level work streams that influence senior management and have an impact on business direction.

What You Will Achieve

• Line Management: Partners with the Study Management Group Lead on defining & providing managerial leadership of strategies within group and specific implementation of processes, quality goals and standards; Actively develops and retains talent through providing focused career development, performance management, workload balance and an inclusive culture for direct report colleagues; Responsible for the development and adherence to consistent harmonized processes and high-quality clinical trial deliverables for clinical projects; Support and continuously evaluate and evolve the Study Manager role to add value and efficiencies to internal study management; Works with other cross functional lines to improve processes and important quality aspects of studies including site selection, start-up, recruitment and retention practices, Significant Quality Event (SQE) process, data delivery 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 Vendor Category Lead, Feasibility Strategy & Analytics Lead, Clinical Study Group Leads, Global Development Leads and Global Program Managers as needed.
• Study Management Sourcing: Works with SMGL, FSP sourcing partner managers/ GSSO Vendor Relationship & Resourcing Manager to ensure provision of technically trained Study Managers per sourcing strategy; Ensures that oncology studies in the portfolio are appropriately resourced and that FSP resources are being appropriately utilized; Maintains resource assignments on an individual role level for Study Managers, along with Study Manager capacity and utilizations; Ensures optimal use of available resource based on prioritization of the portfolio and proactively adapts resource to planned and emergent portfolio needs; Provides functional role oversight of FSP Study Manager resources through interactions with FSP sourcing partner managers to ensure training/onboarding requirements , adherence to Pfizer SOPs and processes, communication and awareness of FSP sourcing partner manager remediations strategies to address FSP Study Manager performance feedback.
• Study Management Oversight and Asset Study Management 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 management resource requests; Contributes to the operational planning at asset and study levels by contributing to the Program Operational Plan, Trial Operational Plan, Feasibility Alignment Meeting, Study Startup, & Protocol Recruitment Plans of linked studies within an asset/program; Inputs review and approves Study Monitoring Plan within Asset assignment to ensure consistency and excellence; Supports study/program level submission readiness; Provides key information on the studies within the asset/program to ensure coordination of roles for portfolio delivery within GSSO e.g., GSM, SOM, DCSOs, Asset DSMs, Country DSMs, etc. and collaborates with others cross functionally above study as needed to ensure smooth coordination of activities and hand offs impacting GSSO deliverables.
• Subject Matter Expertise: In strong collaboration with other colleagues or functions (peers, project leads, and group leads), the DSM leads or participates in cross departmental initiatives. strategies to ensure consistent processes, specific process improvement initiatives and monitors and reports on implementation progress as appropriate; The DSM provides expertise on the study management related SOPs and serves as a Study Management SME on Business Process Improvements and SOP development/update projects; The DSM proactively shares Study Management best practices across CD&O.
• The DSM may, on occasion, also be required to fulfil the role of a Study Manager in addition to oversight and supervisory responsibilities.

Here Is What You Need (Minimum Requirements)

• Training and Education: Extensive global clinical trial/study management experience; Working knowledge of GCPs, monitoring, clinical and regulatory operations; BS or MBA/MS/PhD with extensive 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, and CRO/ vendor costs projections 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 and leadership soft skills; Establishes strong relationships with peers and stakeholders, strives to understand and meet study/asset/Therapeutic Area 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.

Bonus Points If You Have (Preferred Requirements)

• Direct experience in Global Study Management within Pfizer
• Direct experience as a People Manager within Pfizer
• Direct experience collaborating with Functional Service Providers
• Ability to be on-site at Pfizer Sandwich location when needed

Work Location Assignment: Remote

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!