ROLE SUMMARY

As part of the Clinical Data Sciences group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Director, Group Lead, Data Surveillance, is responsible for delivery of all technical and operational aspects of RBM, including timely and high-quality risk-based monitoring analytics supporting the Pfizer portfolio. The Director, Group Lead, Data Surveillance will manage the Central Monitoring groups, providing oversight of central monitoring deliverables and managerial oversight of Central Monitors. The Central Monitors will support an approach to clinical trial monitoring which utilizes data and site level information to determine needs for performing on-site, remote and centralized activities and focuses resources on risks that have the most potential to impact patients’ safety and data quality.

Overall, responsible for defining, delivering and executing the enterprise level RBM implementation plan including strategy and process definition, technology implementation, training, enterprise change management, and communication plan

ROLE RESPONSIBILITIES

Define and drive global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to deliver high quality clinical data

Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a project

Develop charters, resource utilization and project plans to achieve CDS specific goals

Develop people, including recruitment, retention, and career development and performance management

Able to resolve conflicts, influence and communicate cross-functionally with key stakeholders and customers.

Provides administrative and central monitoring technical and process oversight of teams

Implements organizational design and develop succession planning for RBM in collaboration with other functional leaders

Oversee all technical aspects required to set up and test study level Risk-based Monitoring system

Anticipates, oversees and influences change to position efficient, high-quality implementation of required data flows to incorporate internal and external data sources into Pfizer informatics environment ensuring operational delivery and traceability from source. Ensures appropriate process and documentation are in place to support inspection readiness.

Act as the key scientific and technical central monitoring expert; drive central monitoring strategy within Pfizer’s risk-based model, defining central monitoring standards for the asset, Therapeutic Areas (TA), or global organization.

Serve as Subject Matter Expert (SME) for and oversee the central monitoring activity for one or more asset. Train and mentor colleagues and study teams on central monitoring techniques and strategy.

BASIC QUALIFICATIONS

Bachelor’s Degree. Degree in Life Sciences, Informatics, Computer Science, Statistics, or related business degree with equivalent experience preferred.

Demonstrated relevant experience in a pharmaceutical, biotech, Contract Research Organization (CRO), or Regulatory Agency with an emphasis on building data collection and assimilation solutions.

Demonstrated experience managing complex projects and developing successful partnerships within and across functional areas.

Demonstrated successful experience in all relevant clinical trial activities in a Bio Pharmaceutical or CRO setting

Working knowledge of all phases of clinical trials and multiple indications and/or therapeutic areas. Ability to assess and determine study requirement from protocol review

Strong Project and Risk Management

Understanding of regulatory requirements and relevant data standards.

Strong communication, decision-making, influencing, negotiation, and project management skills.

Technical skill and experience using relational databases and data visualization tools, e.g. Spotfire, JReview.

PREFERRED QUALIFICATIONS

Master’s degree.

Strong people management experience. Proven leadership in a global, matrix environment.

Broad exposure to programming in a clinical trial environment, e.g. Python, R, SAS, SQL, EDC systems.

Preferred 15 or more years’ relevant experience including team management responsibilities.

Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

CDISC (Clinical Data Interchange Standards Consortium) knowledge and experience

Proficient experience using commercial RBQM systems (e.g. CluePoints)

Experience with one or more programming languages (e.g. SAS, Python, R) and data visualization tools (e.g. Spotfire, jReview, Tableau)

Knowledge of risk-based monitoring principles and associated analytics/metrics

Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in a matrix environment

Bachelor’s degree required. Degree in scientific, technical or analytic field preferred. Master’s degree preferred.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.