The Director of Country Operations Management will provide managerial oversight to Country (study) Operations Manager (CsOM) colleagues in their respective groups and their associated deliverables within and across that Region and Therapeutic area.
The Director of Country Operations Management is responsible for talent development of colleagues, preparing Country (study) Operations Managers to deliver on studies. They are accountable to ensure all assigned direct reports are appropriately trained. They are accountable to ensure Country (study) Operations Managers are following Pfizer Standard Operating Procedures (SOPs) and providing leadership and appropriate oversight to the Regional/Country Operations Team.
They are accountable to ensure that Country (study) Operations Managers are delivering according to agreed plans and to ensure appropriate proactive escalation of risks and deviations to plans, and that any asset/region/country level strategies are appropriately implemented.
The Director of Country Operations Management will 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 Country (study) Operations Manager They will also interface with FSP managers to resolve issues and escalate resource concerns.
The Director of Country Operations Management is a Subject Matter Expert (SME) on Global Country Operations processes and works with their Country Operations Regional Group Lead to facilitate the sharing of therapeutic/functional area expertise and best practices within their group and where applicable across the Global Country Operations organization. They may sponsor, lead or represent Global Country Operations on cross-functional cross-departmental or enterprise level work streams that influence senior management and have an impact on business direction.
They will interface with various stakeholders across the organization including but not limited to Asset DSMs, Clinical Study Group Leads, DCSOs and other leaders within Global Country Operations to ensure appropriate issue resolution/escalation and healthy stakeholder relationships.
They are accountable for building and ensuring functional area expertise and technical operations management expertise for their group of direct reports through recruitment and talent development/management of staff and the development of training strategies to enhance Global Country Operations.
Line Management of Country study Operations 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 Country study Operations 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
· Work with sourcing partner/resourcing lead to ensure provision of technically trained Country study Operations Managers per sourcing strategy
· Liaise with Functional Service Provider Line Managers on ensuring accountability and performance for their CsOMs
Subject Matter Expertise:
In strong collaboration with other colleagues or functions (peers, project leads, and group leads):
o Leads cross departmental initiatives
o Implements strategies to ensure consistent processes
o Leads and/or participates in specific process improvement initiatives; monitors and reports on implementation progress as appropriate
o Provides expertise on the study management related SOPs and serves as a Global Country Operations SME on BPIs and SOP development/update projects. Proactively shares best practices across CD&O.
The DCOM may assume Asset-Level responsibilities within their assigned portfolio taking accountability for delivery of studies conducted under that program
The DCOM may have regional level responsibilities including but not limited to resourcing of countries within their regions, escalation pathway for region, DCSO liaison
QUALIFICATIONS / SKILLS
Training and Education
Extensive global clinical trial/study management experience
Working knowledge of GCPs, monitoring, clinical and regulatory operations
BS or MS/PhD – with significant 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)
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
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
Reports to Study Management Group Lead
Within CD&O: GSSO Lines
Within PR&D: Portfolio and Project Management, Clinical Data Quality, Statisticians; Clinical Programming Group Lead; DMM Group Leads, Outsourcing Leads, Portfolio Sourcing Team Leads
Other Pfizer: Pharm Sci, Finance and Procurement, Legal
Externally: Functional Service Providers, CRO Study Management & Leadership/ Site Management, CRO Feasibility/Start-up, and other 3rd party vendors
Supervision
Depending on the Group, will provide line management for 6-12 Country study Operations Manager.
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!
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