Director, Clinical Risk Management Post Approval Delivery Unit in High Wycombe

Responsibilities include directing the overall risk management of a Disease Area Stronghold (DAS) or development phase. Coordinate with CRM Representatives to identify, assess, and mitigate quality risks that could affect trial data integrity, patient rights, safety, or well-being. Oversee execution of data-driven, risk-based trial and program oversight activities to ensure quality, regulatory compliance, and inspection readiness.

Establish goals, conduct mid-year and end-of-year reviews, and support career development for CRM Representatives. Lead strategic guidance on quality risk assessments, risk entries, and mitigation strategies and approve Clinical Quality Plans (CQP) risk monitoring information when assigned. Drive quality risk monitoring reviews, coach colleagues, and maintain a strategic communication framework with business partners and quality governance.

Consult, assess, and manage significant quality issues (SQI) per corporate standards, escalating to senior R&D management and providing initial breach evaluation when necessary. Assist in developing and implementing Corrective and Preventative Action (CAPA) plans, monitoring effectiveness checks across inspection, audit, and self-identified contexts. Lead key inspection processes, develop inspection narratives, prepare sites for inspection, and coordinate mock inspections in partnership with Regulatory Compliance teams.

Provide front-end and back-end support for Sponsor-Monitor inspections at J&J sites and remote support for investigational site inspections. Offer independent consultancy on research quality and compliance to business partners, ensuring consistent interpretation of international regulations and policy. Support and lead the coordination of quality integration for acquiring assets or companies, delivering robust documentation within integration plans and executing responsibilities per those plans. Provide guidance to stakeholders, contribute to Quality Agreements with development partners, and facilitate asset divestment activities when required.

Qualifications & Requirements:

• Bachelor's degree in a scientific, medical, or related discipline.
• Minimum of 10 years experience in the healthcare industry (pharmaceutical, contract research organization, or healthcare/hospital system).
• Proven strong GCP quality and/or clinical trials experience.
• Excellent interpersonal, oral, and written communication skills for cross-functional collaboration.
• Flexibility to respond to changing business needs.
• Ability to operate in culturally diverse environments and understand regional and global business structures.
• Proficiency in Microsoft Office applications.
• Required to speak and write English fluently.
• Acceptable travel up to 10%, primarily domestic with some international travel.

Required Skills:

• Budget Management
• Clinical Research and Regulations
• Clinical Trials Operations
• Compliance Management
• Compliance Risk
• Continuous Improvement
• Developing Others
• Fact-Based Decision Making
• Inclusive Leadership
• Leadership
• Operations Management
• Performance Measurement
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Risk Assessments
• Standard Operating Procedure (SOP)
• Tactical Planning
• Vendor Selection

Preferred Skills:

• Experience with fundamentals of clinical trial risk management
• Experience working to ICH guidelines
• Knowledge of GMP, GLP, and/or GPvP
• Health Authority Inspection experience (FDA, EMA, and other inspectorates)
• Strong Project Planning/Maintenance skills
• Experience in managing escalations and CAPA support/advisement
• Experience with data analytics and visualization tools (e.g., Tableau, Spotfire)
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)

Location: This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Focus your application on the specific country that aligns with your preferred location.