Senior Clinical Development Manager

Jobtailor; Reigate and Banstead; On-site; GBP 130,000 - 180,000; Full time

Job summary

Jobtailor is seeking an MD-qualified medical professional to provide medical oversight for multiple clinical trials. The role focuses on protocol design, data integrity, and safety monitoring, with a strong emphasis on AI-enabled approaches in trial execution.

The position requires extensive experience in biopharmaceutical clinical development, regulatory knowledge, and the ability to lead large teams while ensuring high-quality deliverables across global studies.

Qualifications

• MD or equivalent medical qualification required.
• Extensive clinical development and regulatory experience in biopharmaceuticals or academic research.
• Knowledge of ICH/GCP and adverse event management.
• Demonstrated clinical, administrative, and project management capabilities.
• Experience leading large teams in clinical development.

Responsibilities

• Provide medical oversight for trial integrity and participant safety.
• Deliver high-quality protocols and support trial execution.
• Review data, safety, and risks; develop mitigation strategies.
• Utilize AI-enabled tools in design, data review, and risk detection.
• Coordinate protocol design, data standards, SAPs, and TLFs.
• Oversee informed consent processes and engage with stakeholders.
• Develop Integrated Quality Management Plans and risk management strategies.
• Lead Data Monitoring Committees and safety reviews.
• Ensure regulatory filings support clinical development activities.
• Support audits, inspections, and regulatory responses.

Skills

Effective verbal and written comms

Team Management

Leadership

Project Management

Regulatory Compliance Knowledge

AI-enabled tools utilization

Education

MD or equivalent medical qualification

Postgraduate Training In Medical Discipline

Fellowship In Drug Development

Tools

AI-enabled Clinical Development Tools

Data Visualization Tools

Automation Tools

Digital Clinical Trial Technologies

Job description

• Provide medical and scientific oversight for the integrity of studies and well-being of clinical trial participants
• Deliver high-quality protocols and support clinical study execution
• Review clinical data, safety, and risks and develop mitigation strategies
• Use AI-enabled clinical development and digital approaches in trial design and execution
• Support protocol design and lead or support timely protocol delivery
• Provide clinical input to data standards, data collection, data review, SAP, TLFs, and BDR
• Manage Informed Consent Documents and respond to external stakeholder questions
• Develop the Integrated Quality Management Plan
• Establish and oversee independent study committees, including Data Monitoring Committees and endpoint adjudication committees
• Review and approve risk management and safety review plans and oversee risk mitigations
• Review country selection, develop site selection criteria, ensure protocol-specific training, and approve investigator meeting plans
• Serve as primary medical and clinical contact for external investigators and internal study teams
• Review and manage protocol deviations and approve protocol amendments
• Review patient-level, cumulative, and safety data; track and reconcile serious adverse events
• Lead data presentations during Safety Review Team meetings
• Perform medical monitoring for one or more clinical trials
• Ensure inspection readiness for clinical documents
• Support interpretation and communication of clinical trial data
• Review Clinical Study Reports and narratives; support safety and efficacy disclosure and primary publications
• Provide clinical support during audits and inspections
• Support clinical sections of regulatory filings, including PIPs, IBs, IND/NDA annual reports, PSURs, and regulatory responses
• Support responses to regulatory queries and audit/inspection findings and Clinical Trial Applications
• Ensure compliance with internal and external standards
• Contribute to continuous improvement, process enhancement, and innovative clinical trial execution
• Use AI-enabled tools and analytics for clinical data review, signal detection, and risk identification
• Support innovation, user feedback, and adoption of digital clinical development tools

Requirements

• MD or equivalent medical qualification
• Strong experience and track record of success in the biopharmaceutical industry in clinical research and development or academic clinical research
• Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, and adverse event management
• Demonstrated clinical/medical, administrative, and project management capabilities
• Effective verbal and written communication skills
• Demonstrated experience managing and training large teams in clinical development
• Demonstrated experience in designing and launching large teams preferred
• Demonstrated use of AI-enabled tools, automation, data visualization, or digital clinical trial technologies
• Knowledge of therapeutic development, clinical development or lifecycle strategy, disease areas, and drug development
• I&I clinical expertise preferred
• Ability to apply digital and AI-enabled tools to improve clinical development quality, efficiency, and decision-making
• Postgraduate training/certification/fellowship in a medical discipline or drug development preferred
• Scientific productivity such as doctoral thesis, publications, or research reports preferred

Core Competencies

Demonstrates expertise in clinical trial oversight, protocol design, and regulatory compliance, with a strong focus on utilizing AI-enabled tools to enhance clinical development processes. Proven ability to manage teams, ensure data integrity, and communicate effectively with stakeholders.

Highest-signal resume keywords

• MD Or Equivalent Medical Qualification
• Clinical Development Expertise
• AI-Enabled Tools Utilization
• Project Management Capabilities
• Regulatory Compliance Knowledge

Hard Skills

• Clinical Trial Oversight
• Protocol Design
• Data Review
• Risk Management
• Adverse Event Management
• Clinical Study Report Review
• Informed Consent Management
• Data Monitoring Committee Oversight
• Regulatory Filing Support
• Therapeutic Development Knowledge

Soft Skills

• Effective Communication Skills
• Team Management
• Leadership

Certifications & Qualifications

• Postgraduate Training In Medical Discipline
• Fellowship In Drug Development

Industry Keywords

• Biopharmaceutical Industry
• ICH/GCP
• Clinical Research
• Global Regulation
• Clinical Development Lifecycle
• Safety Review
• Process Enhancement
• Continuous Improvement

Tools & Technologies

• AI-Enabled Clinical Development Tools
• Digital Clinical Trial Technologies
• Data Visualization Tools
• Automation Tools