Program Patient Safety Lead
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Make your mark for patients
We are looking for a Program Patient Safety Lead who is passionate agile and detail-oriented to strengthen our Early Clinical DevelopmentBenefit Risk and Medical Safety Unit team. This role can be based in one of our hubs in Braine lAlleud Belgium (preferred); Slough UK; or Raleigh US.
About the role
The Candidate Benefit Risk Lead is accountable for the strategic planning communication and delivery of benefit-risk assessments and risk management strategy (Benefit-risk assessment plan; BRAP) for assigned clinical-stage candidates. This includes identifying emerging safety concerns evaluating benefit-risk outcomes and developing effective risk management strategies.
Who youll work with
You will work transversally with multiple UCB stakeholders (Clinical Development Quantitative Clinical Pharmacology Regulatory Statistics and Non-clinical Safety amongst others) and patients to drive and implement program safety strategies. Youll lead the cross-functional Benefit Risk Team (BRT) empowering and inspiring team members to take ownership of their responsibilities and use data-driven insights to inform decisions.
What youll do
- Drive the program-specific safety strategy and ensure high-quality BRAP outputs with clarity transparency and key messaging.
- Implement safety monitoring and risk management strategies in collaboration with cross-functional teams.
- Communicate insights to support decision-making at internal governance bodies (eg. EDM PPC BRB).
- Analyze and interpret safety data (clinical regulatory legal product quality) to identify potential new risks.
- Author and review documents in accordance with global clinical development strategy and regulatory submission requirements.
- Apply innovative approaches and technologies for data collection documentation and evidence generation.
- Make ethical decisions aligned with UCBs values prioritizing patient safety and regulatory compliance.
Interested Were looking for:
- MD preferred PhD PharmD or equivalent with relevant experience
- Significant experience in early clinical development (first in human to proof of concept) and risk management; preferably in industry environment.
- Experience in Phase 1 trials and/or Gene Therapy is highly preferred.
- Strong knowledge of Good Clinical Practice and international drug safety regulations.
- Demonstrated leadership in complex dynamic environments with short timelines and ambiguity.
- Cross-functional collaboration skills to ensure credible communication with the external medical and scientific community and for internal communication.
- Excellent English communication skillsverbal written and presentation skills
- Proficient and positive attitude toward using digital tools
Are you ready to go beyond to create value and make your mark for patients If this sounds like you then we would love to hear from you!
About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are around 8500 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Key Skills
- Project Management Methodology
- Project / Program Management
- Program Management
- Management Experience
- Microsoft Powerpoint
- Project Management
- Microsoft Project
- Budgeting
- DoD Experience
- Leadership Experience
- Supervising Experience
- Contracts
About Company
UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We're here because we want to transform patients’ lives by pushing the boundaries of what is possible.To achieve our ambition, we w ... View more
