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- Tasks: Lead EU clinical trial programs from design to reporting, ensuring quality and safety.
- Company: Global specialty pharmaceutical group focused on innovative treatments.
- Benefits: Competitive salary, hybrid working model, and opportunity for professional growth.
- Other info: Dynamic role with high visibility and ownership in a growing global organisation.
- Why this job: Make a real difference in patients' lives while working with leading scientific experts.
- Qualifications: Graduate degree in relevant field and experience in managing EU clinical trials.
The predicted salary is between 60000 - 80000 £ per year.
We are looking for a Clinical Program Lead for a global specialty pharmaceutical group dedicated to developing and commercialising innovative treatments for patients with genetic, metabolic, systemic, and life-threatening conditions, to join the Global Clinical Affairs team and lead the delivery of EU clinical trial programs.
Key Responsibilities
- Clinical Program Delivery
- Lead end-to-end EU clinical programs from design through reporting
- Implement clinical program strategy and contribute to overall Clinical Affairs objectives
- Maintain holistic oversight of timelines, risks, quality, and budgets
- Proactively communicate progress, risks, and issues to senior leadership
- Drive cross-functional alignment and knowledge sharing
- Study Execution & Oversight
- Lead protocol development, applying Quality by Design principles
- Oversee study monitoring, ensuring data quality, integrity, and participant safety
- Supervise data management activities including cleaning and review
- Review analyses and lead Clinical Study Report (CSR) development
- Ensure inspection readiness and support GCP audits and regulatory inspections
- Sites, Vendors & External Partners
- Oversee site selection, contracts, budgets, recruitment, and performance
- Manage relationships with investigators, expert physicians, and key opinion leaders
- Lead investigator meetings, site initiation, and accreditation activities
- Select and oversee CROs and service providers, ensuring performance against scope and quality expectations
- Leadership & People Management
- Lead, coach, and mentor members of the Clinical Operations team
- Manage direct reports and support professional development initiatives
- Oversee resource planning and workload allocation within the program
- Support internal training and capability building
- Program Enablement & Innovation
- Contribute to clinical process improvement and trial modernisation initiatives
- Support digital integration and operational efficiency across the portfolio
- Represent the company at conferences, external events, and regulatory meetings as required
Essential Requirements
- Graduate degree in Biological Sciences, Nursing, Pharmacy, or Medicine (postgraduate qualification desirable)
- Strong working knowledge of EU clinical trial regulations and ICH-GCP
- Proven experience managing EU clinical trials and clinical programs
- Experience overseeing data management and clinical reporting
- Demonstrated leadership and team management capability
- Strong project management, communication, and stakeholder engagement skills
- Ability to work independently and manage complex programs to tight timelines
What's on Offer
- Competitive salary and benefits package
- Opportunity to work alongside world-leading scientific experts
- High level of ownership and visibility within a growing global organisation
- Hands-on role contributing directly to therapies that improve patients' lives
- Hybrid working model with flexibility
Desired Skills and Experience
- Clinical Leadership & Strategy
- Clinical Program Leadership
- EU Clinical Trial Strategy
- End-to-End Clinical Program Delivery
- Portfolio Oversight
- Clinical Development Planning
- Quality by Design (QbD)
- Clinical Affairs Strategy
- Cross-Functional Leadership
- Risk Assessment & Mitigation
- Governance & Decision Making
Clinical Operations & Study Execution
- Interventional Clinical Trials
- Non-Interventional / Observational Studies
- EU Clinical Trial Management
- Study Start-Up to Close-Out
- Site Selection & Feasibility
- Investigator Management
- Site Initiation & Accreditation
- Recruitment Strategy & Oversight
- Protocol Development
- Study Monitoring Oversight
- Vendor Oversight (CROs, Service Providers)
Regulatory, Compliance & Quality
- ICH-GCP Compliance
- EU Clinical Trial Regulations
- Inspection Readiness
- GCP Audits & Inspections
- Ethics Committee Submissions
- Competent Authority Submissions
- SOP Development & Adherence
- Trial Master File (TMF) Oversight
- Records Management
- Participant Safety & Data Integrity
Data, Reporting & Scientific Excellence
- Clinical Data Management Oversight
- Data Cleaning & Validation
- Data Integrity & Quality Control
- Clinical Data Review & Interpretation
- Statistical Review
- Collaboration
- Clinical Study Reports (CSRs)
- Scientific Literature Review
- Medical & Scientific Writing
- Benefit-Risk Evaluation
Stakeholder & External Engagement
- Principal Investigator Relationships
- Key Opinion Leader (KOL) Engagement
- Investigator Meetings
- Regulatory Authority Meetings
- Conference Representation
- External Communications Support
People & Resource Management
- Line Management
- Team Leadership & Mentoring
- Performance Coaching
- Resource Planning
- Workforce Allocation
- Training & Capability Building
- Professional Development Support
Process Improvement & Innovation
- Clinical Process Optimisation
- Trial Modernisation
- Digital & Technology Integration
- Operational Efficiency Initiatives
- Knowledge Transfer & Best Practices
Core Professional Skills
- Project Management
- Budget & Timeline Management
- Complex Problem Solving
- Analytical & Observational Skills
- Strategic Communication
- Stakeholder Alignment
- Independent Decision Making
- Time & Priority Management
Clinical Program Lead employer: EPM Scientific
Contact Detail:
EPM Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Program Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical field, attend industry events, and engage on platforms like LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its clinical programs. Understand their recent projects and challenges in the EU clinical trial landscape. This will help you tailor your responses and show that you're genuinely interested in the role.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the responsibilities of a Clinical Program Lead. Highlight your leadership skills and project management expertise to demonstrate that you’re the perfect fit for the team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Clinical Program Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Program Lead role. Highlight your experience with EU clinical trials and any leadership roles you've held. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical program delivery and how you can contribute to our team. Keep it engaging and relevant to the job description.
Showcase Your Skills: Don’t forget to highlight your project management and communication skills in your application. We’re looking for someone who can manage complex programs and engage with stakeholders effectively, so make sure these come through!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets to us quickly and efficiently. Plus, you’ll find all the details you need about the role there!
How to prepare for a job interview at EPM Scientific
✨Know Your Clinical Trials
Make sure you brush up on your knowledge of EU clinical trial regulations and ICH-GCP. Be ready to discuss your previous experiences managing clinical trials, as well as how you’ve applied Quality by Design principles in protocol development.
✨Showcase Your Leadership Skills
As a Clinical Program Lead, you'll need to demonstrate strong leadership capabilities. Prepare examples of how you've led teams, managed direct reports, and supported professional development initiatives in your past roles.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills and ability to manage risks. Think of specific scenarios where you had to overcome challenges in clinical program delivery or stakeholder engagement, and be ready to share those stories.
✨Communicate Clearly and Confidently
Effective communication is key in this role. Practice articulating your thoughts clearly, especially when discussing complex topics like data management and study oversight. Remember, it’s not just about what you say, but how you say it!