Director, Group Lead, Data Surveillance, Clinical Data Sciences

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 Pfizers 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

• Bachelors 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

• Masters 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

• Bachelors degree required. Degree in scientific technical or analytic field preferred. Masters degree preferred.

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