Description

Summary:

The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable for innovation, standards, processes and infrastructure in RBQM. Accountable for selection and oversight of external vendors within technical scope. Will also be responsible for the internalization and oversight of the RBQM model. Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management, performance, and development, both technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance.

This position requires excellent project and people management skills, verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface with technical teams in other functions to triage monitoring or other actions with the investigational sites. Additionally, this position possesses adequate knowledge of drug development in pharmaceutical industry across different disease areas, and the ability to determine risk factors with and for other technical departments (eg, Clinical, Medical, Safety, Data Management, Statistics). This position requires skills in working in a fast-paced environment, continuous improvement, change management, and risk management. Experience working and managing CROs in the RBQM space is also required.

Responsibilities:

- Group strategy: Sets the vision and strategy for the group including overall vision for a robust risk assessment, mitigation, central (statistical) monitoring and signal detection. Identifies areas to be improved and initiates rectification or remedial activities. Develops the strategy for technology and innovation to improve the overall efficiency in project execution and deliverables. Oversees or initiates RBQM operating procedures and standards; monitors and enforces compliance of standard procedures and processes. Proactively manages resource planning to ensure adequate resources are available to business priorities.
- RBQM Strategy: Establishes and drives standard RBQM strategy, provides strategic or tactical input to the RBQM projects. Communicates and collaborates with other function leaders during this process to support decision making and execution. Develops overall outsourcing strategy for the function including internalization strategy and execution plan. Responsible for developing, implementing, and maintaining the plan to internalize RBQM efforts while overseeing the 3-way model for ongoing/near term new trials.
- External Vendor Oversight: Manages higher-level negotiation with external vendors. Provides oversight of quality/performance and budget, resources and timelines across the department and ensures timely delivery of high-quality deliverables at reasonable cost. Provides documented oversight of the external vendors/sponsor partnership under the RD-wide vendor oversight structure. Strategically leverages external expertise in supporting RBQM activities.
- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical variables and processes, and build appropriate mitigations. Drive interface with Integrated Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics including Quality Tolerance Intervals, Key Risk Indicators, Key Performance Indicators, and grouped variables for signal detection. Articulate to Study Team for appropriate site and study level triage, actions, and rectifications.
- Deliverables: Working with RBQM leaders to provide oversight of activities performed by the internal RBQM function in association with other DS functions, or any vendor outsourced roles on RBQM behalf. Advises, directs, prioritizes, and monitors all RBQM activities and deliverables in terms of timeline and quality.
- People Management Leadership: Accountable for the management, development, recruitment and training of employees within the departmental scope to meet current and future business needs. Provides exceptional leadership to employees within responsible areas. Leads coaching and development of employees across the function. Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. Manages and provides guidance to team members, including organizing and prioritizing group tasks, performing training, and managing performance. Responsible to create an environment where employees feel engaged and empowered, and take pride in their roles, responsibilities, and deliverables.

Requirements

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)
- Master's degree in life sciences, data science, statistics, or related field required
- PhD in life sciences, data science, statistics, or related field preferred

Experience Qualifications:
- 11 or more years of experience in RBQM and/or related work experience in pharmaceutical company, Biotech, or similar environment (e.g., CRO). required
- 5 or more years managing people required
- 5 or more years managing projects required