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About the Role

The Director of Site Management and Monitoring (DSMM) partners with the Director of Clinical Site Operations (DCSO) to ensure appropriate site management and monitoring resources are in place for end-to-end study start-up, management, and monitoring activities. This role involves line management, overseeing job functions, and ensuring participant safety and data quality in accordance with regulations and Pfizer standards. The DSMM collaborates cross-functionally to provide input on site selection and facilitate regulatory approvals, executing investigator site and recruitment strategies. They also lead and implement strategic initiatives to shape the clinical development environment, manage risks, and identify opportunities for clinical trial conduct.

Responsibilities

Line Management of Site Management and Monitoring roles
Lead and coach allocated resources within assigned country/cluster/region
Overall accountability for the Growth and Development of the Site Operations organization (Individual Contributors)
Oversee job functions as described in the relevant job descriptions and ensure compliance with training requirements
Closely liaise with the FSP Managers of Site Management and Monitoring roles, as described in standard contracts with the FSP organizations to oversee FSP roles
Where required, perform joint site visits with direct reports to assess performance
Demonstrate leadership in the resolution of site/country/cluster/regional issues to maintain site startup, quality and strong investigator site relationships
Establish consistent direction and priorities across assigned countries/cluster/region
Responsible for country level input into country selection, pre-feasibility, study design and site identification and selection; when necessary, support and champion existing associated processes
Ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders
Responsible for the oversight of the operational delivery including the site management and monitoring activities as performed by the selected FSPs or by partner CROs, safety and quality of sites in the country/cluster/region
Demonstrate Therapeutic Area expertise, where appropriate
Responsible for timely and quality site start-up including activation
Mitigate systematic deficiencies in clinical trial conduct across sites, to improve quality and participant safety in selected investigational sites
Ensure sites with virtual monitoring and oversight capabilities are identified and enabled, as applicable
Share country/cluster/regional issues and trends with stakeholders (e.g., study/program teams, local Medical Affairs teams, local CROs, Medical Quality Assurance, etc.), as needed
Collaborate with local contract organizations (e.g., CRO) as needed to ensure overall delivery, quality, local regulatory and GCP compliance
Build portfolio-aligned, investigational sites/site organization relationships and participate in local industry forums to shape performance of ethical clinical research, as needed
Shape local clinical research environment by promoting GCP, ethics, regulatory process, and investigator training
Contribute to Area and Global GSSO strategies by leading and participating in area or global initiatives
Ensure a proactive relationship is maintained between GSSO colleagues and other in-country functional lines such as regulatory, safety and medical affairs
Proactively manage the relationship with other functional lines within GSSO, e.g., study start-up (SUPM, CTA, SAP, ICL), regulatory/CTRO, Investigator Payment leads, OARS, Patient recruitment and study management to drive successful portfolio delivery in-country
Proactively manage the country relationship with local external stakeholders (e.g., investigators, regulators, ethics committees, pharma associations, etc.)
Develop relationships with the CROs/vendors locally in support of delivery of GSSO strategies
Driving effective resource management across portfolio for designated countries/clusters/regions to ensure balanced resource allocation for Site Management and Monitoring roles across the Therapeutic Areas (TA) and regions
Oversee and drive quality & compliance and goal related metrics for given country/ TA, including FSP management metrics
Provide status updates in order to manage progress proactively as needed

Requirements

Must be fluent in English
Local language capabilities are an advantage
Extensive knowledge (minimum 8 years) of clinical trial methodologies with proven ability to deliver high-quality clinical trial conduct obtained while working with a multi-national pharmaceutical company and/or clinical research organization
Demonstrated People management experience
Ability to lead and manage diverse teams
Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities
Ability to lead and influence a matrix environment, capable of driving initiatives across GSSO
Demonstrated understanding of People Experience (PX) procedure and policies at global and local level
Demonstrated ability to engage with senior stakeholders internally and externally to the organization
Ability to work effectively with line support functions including finance, PX across the region
Ability to both manage the resources required to deliver on organizational commitments and perform specific tasks of the roles managed
Ability to effectively coach and train direct reports including management of escalated issues from sites / investigators, and development of core competencies
Availability to travel within the region and/or globally as required
Agility to adapt to VUCA (Volatility, uncertainty, complexity and ambiguity)/evolving environment
Breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
Candidates must be authorized to be employed in the U.S. by any employer
U.S. work visa sponsorship is not available for this role now or in the future
This position requires permanent work authorization in the United States

Skills

Clinical trial methodologies
People management
Leading and managing diverse teams
Adaptive risk management
Continuous learning
Leading and influencing a matrix environment
Driving initiatives across GSSO
Understanding of People Experience (PX) procedures and policies
Engaging with senior stakeholders
Working effectively with line support functions
Managing resources
Performing specific tasks of managed roles
Coaching and training direct reports
Management of escalated issues
Development of core competencies
Adaptability to evolving environments

Location

Remote

Work Type

Remote
Full-time

Experience Level

Minimum 8 years of clinical trial methodologies experience
Extensive clinical research experience

Education Level

BS/BSc/MS/MSc or equivalent
PhD/MD or equivalent

Salary/Compensations

$176,600.00 to $294,300.00
Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary
Eligibility to participate in our share based long term incentive program

Benefits

Comprehensive and generous benefits and programs
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

About the Company

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users.

Equal Opportunity

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.