Senior Director, Clinical Compliance and Trial Support

Role Summary

The Senior Director, Clinical Compliance and Trial Support is accountable for the continuous optimization, harmonization, and innovation of Clinical Operations ways of working, with responsibility for clinical compliance and inspection readiness across clinical development functions, Trial Master File (TMF) quality and oversight, and support functions across the portfolio. The leader has thorough knowledge of the evolving regulatory and operational landscape, identifies gaps, performs root cause analysis, and drives process improvements forward.

Responsibilities

• Clinical Operations Leadership, Optimization and Study Delivery
  • Manage and lead a team across Clinical Operations key functions and roles: TMF oversight, clinical compliance, and other clinical trials supporting roles.
  • Ensure an appropriate level of qualified and trained resources within assigned groups to support study delivery within timelines, budgets, and quality expectations, according to ICH/GCP, company control documents, and regulatory requirements.
  • Lead the development, roll-out, and training of optimized practices, tools, and processes related to Clinical Operations roles across therapeutic areas and programs.
  • Set and implement management monitoring of effectiveness and efficiency of all roles within remit, leveraging appropriate KPIs and metrics.
  • Ensure that a high level of Quality Control (QC) is embedded in the team’s day-to-day activities.
  • Ensure harmonization at task, activity, and process level for all staff within remit, promoting standardization while allowing fit-for-purpose flexibility.
  • Drive the implementation of new practices and best-practice sharing across studies, programs, and functions.
  • Define and analyze resource requirements based on study projections and business needs in collaboration with the team and Clinical Operations Leadership.
  • Ensure resource prioritization according to business priorities and corporate objectives.
  • Drive innovative approaches to study delivery through external-facing advances in technology and science.

• Clinical Compliance & Inspection Readiness
  • Lead Clinical Operations compliance activities in partnership with QA and Regulatory to ensure adherence to ICH E6(R2/R3), ICH E8(R1), 21 CFR Parts 11, 50, 54, 56, 312, the EU Clinical Trials Regulation (EU) No 536/2014, and applicable local regulations across all IMCR-sponsored clinical trials.
  • Establish and maintain a risk-based quality management framework, including risk assessments, key quality indicators (KQIs/KPIs), and quality metrics for all IMCR-sponsored trials, consistent with ICH E6(R2/R3) expectations for quality management.
  • Drive inspection readiness across studies and programs, including oversight of preparation for GCP inspections and audits (e.g., FDA, EMA, MHRA) and ensuring effective CAPA development, implementation, and follow-up.
  • Partner with QA to contribute to the development, maintenance, and training of Clinical Operations SOPs, work instructions, and guidance documents to ensure consistent, compliant execution across all clinical development functions.

• Trial Master File (TMF) Strategy & Oversight
  • Provide sponsor-level leadership and oversight of the eTMF strategy, structure, and quality for IMCR-sponsored trials, whether the TMF is held internally or via a hybrid model.
  • Ensure TMF content and processes are aligned with ICH E6(R2/R3) essential document requirements and the EMA Reflection Paper on the Trial Master File (TMF) and GCP Inspectors’ Expectations (EMA/INS/GCP/856758/2018).
  • Implement TMF health checks, quality control, and reconciliation activities to maintain an inspection-ready TMF throughout the study lifecycle.
  • Define and govern TMF responsibilities and expectations, including TMF governance, metrics, and periodic reviews.
  • Promote continuous improvement and best practices in TMF management, including training, guidance, and knowledge sharing with study teams.

• Other Duties
  • Lead and/or contribute to department initiatives and assist in the design and implementation of standardized work processes.
  • Provide expert and collegiate support to other members of the drug development team to ensure the success of the company’s portfolio and regulatory milestones.
  • Assist in SOP and working instruction development, review, and approval.
  • Perform other duties as assigned, consistent with the scope and level of this role.

• Supervisory Responsibility
  • Recruit, retain, lead, and develop a team of key Clinical Operations supportive staff: clinical compliance/quality oversight, TMF oversight, and other clinical trials supporting roles, all while supporting study delivery across the portfolio.
  • Lead and direct staff by providing objectives aligned to company vision and strategy, setting clear expectations and providing feedback on performance, and creating opportunities for development; coach and keep staff motivated during heavy workload and changing priorities.
  • Establish performance measurements for all staff – track performance, review outcomes, and identify corrective actions where needed.
  • Contribute to staff capability building by supporting onboarding, training, and community forums.
  • Ensure robust performance and talent management processes are in place and implemented.

Education / Experience

• BS/BA degree in related discipline
• Typically requires a minimum of 15 years of significant experience in managing clinical operations with strong knowledge of ICH/GCP and Regulatory requirements driving clinical development.
• Experience in People Management and leading teams, to include management of resources from different sources in different locations (internal, external, functional service providers).
• Experience in Biotech/Pharmaceutical industry preferred.

Knowledge / Skills

• Creative thinker able to modernize approach to clinical delivery, leverage external technology and networks to deliver value.
• Proven clinical development experience across all phases of development (I-IV).
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict.
• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Demonstrated ability to develop and lead the execution of strategy and business transformation and initiatives.
• Change management experience.
• Experience in assessing technology, external environment & R&D process requirements to successfully drive operational productivity, strategy optimization, process improvements and efficiencies.
• Strong knowledge of ICH-GCP and Regulations.
• Able to manage and lead teams across multiple locations; leads by example and promotes collaboration, effective communication, and leadership in others.
• Strong communication and presentation skills including strong ability to network and negotiate at all levels in the organization.
• Broad understanding of the biotech / pharmaceutical industry and the clinical development process.