Senior Director, Clinical Compliance and Trial Support
UK Visa Sponsorship Analytics
Analytics are greyed out due to low classification confidence (42.0%).
Occupation Type
Quality assurance and regulatory professionals
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£48,200
(£24.72 per hour)
Occupation rate applies
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Description
Location of role Radnor, PA, Gaithersburg, MD, Oxford, UK
Department Clinical Operations
Key Responsibilities At IMCR, our Clinical Operations team leads the global execution of clinical trials, ensuring every study meets the highest standards of quality and regulatory compliance. By following international guidelines and local regulations, we deliver reliable data that helps bring innovative therapies to patients worldwide.
The Senior Director, Clinical Compliance and Trial Support is accountable for the continuous optimization, harmonization, and innovation of Clinical Operations ways of working, with particular 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 of this group has thorough knowledge of the evolving regulatory and operational landscape, identifies gaps, performs root cause analysis, and drives process improvements forward.
The Senior Director leads a team of Clinical Operations support functions that provide support across the portfolio, including TMF oversight, clinical compliance, and other clinical trials supporting roles. This role is critical to ensuring that adequate and knowledgeable resources are in place for optimal delivery of the portfolio through the successful execution of the goals and deliverables outlined in t
Department Clinical Operations
Key Responsibilities At IMCR, our Clinical Operations team leads the global execution of clinical trials, ensuring every study meets the highest standards of quality and regulatory compliance. By following international guidelines and local regulations, we deliver reliable data that helps bring innovative therapies to patients worldwide.
The Senior Director, Clinical Compliance and Trial Support is accountable for the continuous optimization, harmonization, and innovation of Clinical Operations ways of working, with particular 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 of this group has thorough knowledge of the evolving regulatory and operational landscape, identifies gaps, performs root cause analysis, and drives process improvements forward.
The Senior Director leads a team of Clinical Operations support functions that provide support across the portfolio, including TMF oversight, clinical compliance, and other clinical trials supporting roles. This role is critical to ensuring that adequate and knowledgeable resources are in place for optimal delivery of the portfolio through the successful execution of the goals and deliverables outlined in t
he corporate and program plans.
This role is a member of, and partners with, the Clinical Operations Leadership Team to understand the portfolio delivery strategy and translate that strategy into operational execution while driving continuous improvements and change management. The role is responsible for the harmonization of related business and operational processes between all teams and partners with the Clinical Operations Leadership Team to develop, execute, and deliver short- and long-term strategic objectives.
The Senior Director is responsible for fostering a collaborative culture and works with many internal and external stakeholders to achieve desired outcomes. The person in this role serves as a visible and effective change agent for global initiatives and provides strategic decision-making for all areas of responsibility while nurturing the ideas of others.
As a member of the Clinical Operations Leadership Team, the Senior Director is responsible for the review and approval of Clinical Operations strategies, SOPs and written standards, as well as being a key contributor to issue review and recommendation/resolution processes. The role serves as a champion and leader for staff change management and engagement strategy, continuous improvement projects that promote individual development, team development, development of institutional knowledge, and best practices for leveraging the entire Clinical Operations network in an optimal manner.
This role is a member of, and partners with, the Clinical Operations Leadership Team to understand the portfolio delivery strategy and translate that strategy into operational execution while driving continuous improvements and change management. The role is responsible for the harmonization of related business and operational processes between all teams and partners with the Clinical Operations Leadership Team to develop, execute, and deliver short- and long-term strategic objectives.
The Senior Director is responsible for fostering a collaborative culture and works with many internal and external stakeholders to achieve desired outcomes. The person in this role serves as a visible and effective change agent for global initiatives and provides strategic decision-making for all areas of responsibility while nurturing the ideas of others.
As a member of the Clinical Operations Leadership Team, the Senior Director is responsible for the review and approval of Clinical Operations strategies, SOPs and written standards, as well as being a key contributor to issue review and recommendation/resolution processes. The role serves as a champion and leader for staff change management and engagement strategy, continuous improvement projects that promote individual development, team development, development of institutional knowledge, and best practices for leveraging the entire Clinical Operations network in an optimal manner.
This role is accountable for resource management across assigned areas, including ongoing assessment of resource needs and optimal deployment of resources to support a flexible ClinOps workforce. In addition, this role serves as an expert resource by offering input and ideas to solve operational challenges including process improvement, technology solutions, and overall improvement in workflow cycle times. The Senior Director is a member of the Clinical Operations Leadership Team and supports peers and key stakeholders by contributing to the strategy and management of the broader organization. They lead Clinical Operations and/or cross-functional organizational initiatives and strategies that promote change management to accelerate adoption and typically act as the business process owner (BPO) and/or serve as a subject matter expert for complex Clinical Operations processes.
The Senior Director demonstrates an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking, and standardization across Clinical Operations.
Key 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, budget
The Senior Director demonstrates an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking, and standardization across Clinical Operations.
Key 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, budget
s, 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 acr
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 acr
oss 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.
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
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
- 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.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineere
d drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.