Study Management Group Lead (Sr. Director)

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 will provide direct supervision to Study Management Managers and Study Managers directly assigned to them and provide therapy/functional area specific mentoring and coaching to study managers supporting studies within their portfolio.. They will prepare and support Study Managers to deliver on studies with a focus on customer service, cost, quality & speed.

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. This role also facilitates the sharing of best practices across the Study Management organization.

The Study Management Group Lead will interface with CPM Group leads 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.

T he 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.

RESPONSIBILITIES

• Partners with Head of Study Management and peer Study Management Group Leads to develop strategies and standards to maximize study management competency and skills for study execution
• 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
• Ensures high quality and timely skilled study management support to studies with a focus on cost, quality & speed
• Provides leadership for Study Management group instilling a culture of continuous improvement and focus on improved operational performance
• Works with other cross functional lines to improve processes and important quality aspects of studies including site selection, recruitment and retention practices, 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
• 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
• Works 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
• Maintains awareness of Pharma business trends and external organizational developments to help define the future strategic direction for Study Management and functional area of expertise

QUALIFICATIONS

Training and Education Preferred:

• 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
• BS - minimum of 15 years relevant experience
• MS/PhD - minimum of 10 years relevant experience

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 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 therapeutic / functional area of expertise

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
• Demonstrated knowledge of GCP, clinical research processes and regulatory requirements

Education:

• BS - 15 years relevant experience
• MS/PhD -10 years relevant experience
• PhD, PharmD, M.S. or other professional certification preferred

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.

Medical

#LI-Remote #LI-PFE