Director – Process Management – Clinical R&D

Director – Process Management – Clinical R&D

Requirements

• 12+ years of clinical drug development experience with a Bachelor’s degree or 10+ years experience with post graduate degree.
• Experience in the biotechnology or pharmaceutical industry is required.
• In depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines.
• Demonstrated ability to lead and influence change in process development and system implementation.
• Ability to collaborate effectively with cross-functional teams and subject matter experts.
• Proven ability to synthesize information from multiple sources and make risk-based decisions.

Responsibilities

• Provide strategic oversight for the design, optimization, and scaling of business processes that support Clinical R&D’s goals and growth.
• Lead project teams through the creation, review, and maintenance of procedural documents (e.g., Standard Operating Procedures, policies, job aids), process maps and personnel qualification strategies.
• Partner with Business Process Owners to ensure processes integrate with the end-to-end clinical drug development process and to deliver efficiencies and mitigate compliance risks.
• Ensure that processes are designed with scalability in mind to support growth, as personnel and the portfolio expand.
• Identify gaps and inefficiencies to current state business processes and opportunities for improvement.
• Implement tools required to collect and measure relevant data, identify key performance indicators (KPI), and produce a data-driven analysis of critical functions.
• Define and evaluate metrics to monitor effectiveness of existing business processes.
• Partner with Business Process Owners and IT System Owners in the design, implementation, and release management of clinical systems, i.e., Clinical Trial Management System, electronic Trial Master File, etc.
• Collaborate with Business Process Owners, IT System Owners, functional leaders, subject matter experts (SMEs) and Clinical Quality Assurance to define applicable compliance and business requirements in order to identify and prioritize core business processes based on strategic importance, regulatory requirements, and impact on business operations.
• Develop and implement strategies to ensure ongoing inspection readiness for clinical trials.
• Support GCP audits and inspections by regulatory authorities and business partners.
• Collaborate in the development and delivery of training programs associated with the introduction of new/updated operational procedures or deployment of new/modifications to clinical systems; develop documentation, tools, and training to support adoption.
• Remain informed about changes in regulations, industry standards, and best practices.

Preferred Qualifications

• Experience with Veeva Quality Vault and Veeva Clinical Platform is preferred.