Study Management Group Lead (Executive Director)

ROLE SUMMARY

• The Study Management Group Lead is a Study Management/Execution Subject Matter Expert (SME) within their assigned Therapeutic/Functional Area and accountable for the delivery of studies within that portfolio.
• They are accountable for building and ensuring Therapy/Functional Area expertise and technical Study Management expertise within their group through recruitment and talent development/management of staff and the development of training strategies to enhance study management.
• They are accountable for ensuring program level operational escalations are effectively managed with Clinical Research Organizations (CROs), in close partnership with Clinical, Operations Group Leads, Data Management Group Leads and other leaders as needed. Ensures that operational issues are appropriately escalated and represented at operational and quality review boards.
• The Study Management Group Lead is a Subject Matter Expert (SME) on study management processes and serves as the expert for the GPD organization on those processes under their leadership. This role also facilitates the sharing of best practices across the Study Management organization.
• The Study Management Group Lead will interface with Clinical Operations Heads to ensure appropriate provisioning of trained study managers to studies and interface with the study management and monitoring functions at the CROs to ensure optimization of services.
• The Study Management Group Lead is accountable for the delivery of studies within their assigned portfolio and for ensuring appropriate oversight of the CROs and vendors relating to study and site management deliverables.
• The Study Management Group Lead (where assigned to Start Up) will provide Strategic Direction to the areas of Targeted Investigator Site development, Site Initiation including the utilization of CRSA to complete Initiation Documentations and the Study Start Up Project Management group. They will directly supervise the leaders of these functions with a focus on customer service, cost, quality & speed.

Responsible for site strategy and relationship management:

• Engage Senior Leader stakeholders including WRD and GPD Chief Development Officers and Global Clinical Leads to understand portfolio needs and develop long term investigator site development needs.
• Identify the strategy for partnership with sites to effectively deliver Pfizer's strategy across site countries, and work with the Target Investigator Network Strategy Implementation Lead to ensure full implementation.
• Use local intelligence to identify potential networks / sites and inform the strategy accordingly.
• Coordinate with Study Optimization group to ensure repeated utilization of identified targeted sites.
• Partner with Head of Global Site and Study Operations and peer Study Management Group Leads to develop strategies and standards to maximize study management competency and skills for study execution.
• Partner with Head of Global Site and Study Operations to develop strategy for Study Start Up Project Management and Site Initiation support.
• Provide subject matter expertise regarding operationalization strategy for a therapy area / asset as needed.
• Accountable for delivery of studies within Study Management Group Lead's assigned portfolio.
• Accountable for performance of in-scope Study Start Up Project Management.
• Ensure high quality and timely skilled study management support to studies with a focus on cost, quality & speed
• Provide leadership for Study Management group instilling a culture of continuous improvement and focus on improved operational performance.
• 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.
• Accountable for creating and maintaining a culture of excellence in customer service within group.
• Responsible for the identification, selection, development, performance management, mentoring/training, retention and engagement of Study Managers; Leaders of Site Initiation and Study Start Up Project Management, and their functions.
• Monitor and report on implementation of functional area initiatives.
• Implement organizational design and develop succession planning for functional area in collaboration with other Study Management Group Leads.
• Work with sourcing partner/resourcing lead to ensure provision of technically trained Study Managers per sourcing strategy.
• Ensure oversight of all sourcing partners in the delivery of quality, speed and cost targets.
• Maintain awareness of Pharma business trends and external organizational developments to help define the future strategic direction for Study Management, Targeted Sites, Site Initiation and Study Start Up Project Management.

Training and Education:

• Extensive clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management, knowledge of GCPs, monitoring, clinical and regulatory operations is preferred. In general, candidates for this job would hold the following levels of education/experience:
  • BS - 15 years relevant experience
  • MS/PhD -10 years relevant experience
  • PhD, PharmD, M.S. or other professional certification preferred

Prior Experience Preferred:

• Demonstrated leadership experience with a minimum of 5 years supervisory experience
• Extensive and broad-based experience of clinical trial conduct, global clinical trial operations, working knowledge of GCP and a thorough understanding of the processes associated with study management, monitoring, clinical operations
• 15 years of experience and track record of success in biopharmaceutical industry in clinical research and development
  • Direct study management expertise preferred (however, monitoring or regulatory operations experience would be considered)
  • Demonstrated supervisory responsibilities
• Demonstrated knowledge of GCP, clinical research processes and regulatory requirements
• Demonstrated ability to manage and develop colleagues.
• Demonstrated ability to lead group to achieve common goals
• Demonstrated ability to make strategic use of business data to monitor and raise performance levels
• Demonstrated success/results in prior scientific/administrative management roles
• Experience in Targeted Site methodology and start up oversight

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

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EEO & Employment Eligibility

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