At a Glance
- Tasks: Lead safety strategies and ensure effective risk management for innovative biopharmaceutical products.
- Company: Join Ipsen, a global biopharmaceutical leader focused on transformative medicines.
- Benefits: Enjoy a supportive workplace with growth opportunities and a focus on employee well-being.
- Other info: Embrace diversity and inclusion in a culture that values every voice.
- Why this job: Make a real impact on patient health while working in a dynamic, collaborative environment.
- Qualifications: MD with clinical experience and strong leadership skills in cross-functional teams.
The predicted salary is between 80000 - 100000 £ per year.
About Ipsen
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavour every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
Job Description
Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company? Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.
Why Ipsen?
- Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
- Employee Care: We care for our employees, who are the ambassadors making a real difference.
- Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
- Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.
About the Role
The Global Asset Safety Lead works closely and collaboratively with the Asset Safety Lead to ensure a harmonised and consistent approach for the safety and risk management strategies across the entire clinical development programme.
- Represent the Global Patient Safety (GPS) as a member of the Global Asset Team and Clinical Development Team for one or more products.
- Be the contact person for relevant safety-related deliverables, issues and questions in relation to this (these) product(s).
- Ensure effective proactive medical safety strategies and continuous management of the safety profile for assigned products within the TA Neuroscience.
This is a director level role.
Main Responsibilities
- Provide leadership and expert safety oversight as a key member of the cross-functional Asset Team.
- Support clinical development of the product by leading the delivery of safety driven activities across the full development programme – from FIH studies through to regulatory submission – in close collaboration with cross-functional Asset Team members.
- Accountable for the conduct of safety surveillance and assessment of integrated safety information, to ensure the timely proposal of changes to the safety profile and appropriate risk management and risk minimisation actions, in order to warrant the safe and effective use of Ipsen products in development projects and on the market.
- Actively contribute to the cross-functional working groups as the representative safety expert to ensure these considerations are taken into account during the clinical development of the product.
- Ensure effective proactive continuous management of the safety profile for assigned development compounds and marketed products, so that safety considerations reliably inform project decision-making, and all clinical development and life-cycle management safety milestones are met.
- Implement proactive safety and risk management strategies, agreed cross-functionally with asset team colleagues for assigned products, integrated with clinical development and life-cycle management plans for milestone decisions.
- Clearly communicate and distil complex safety data into meaningful insights for decision-makers.
- Ensure that clinical development plans/life-cycle management plans adequately address the safety questions and deliver the safety strategy for approval by safety governance.
- Lead the development of the Risk Management Plan for assigned products as applicable.
- Chair the PST/BRT if the Asset Safety Lead is unavailable, support B/R assessments and ensure the evaluation of the effectiveness of risk minimisation measures.
- Ensure that all safety-based decisions for benefit-risk assessment are taken in the knowledge of a comprehensive assessment of all available evidence.
- Provide safety expertise, strategies and leadership to the global filing teams for all components of regulatory submissions, health authority questions, and periodic safety reports (PSURs, PBRERs, DSURs).
- Deliver medical safety assessments as required, e.g. in the evaluation of the risk and impact of product quality complaints.
- Ensure that the respective GPS TA Leaders, and thereby Ipsen senior management, are kept informed of any new data that might impact the benefit-risk of Ipsen products, working in collaboration with the Asset Safety Lead.
Qualification
- Doctor of Medicine (MD)
- Extensive clinical experience exercising medical judgment as a physician and several years of PV and/or clinical development experience.
- Experience in leading Cross functional Global Product Teams, Safety Teams and Clinical Development Teams.
- Knowledge of product development processes and experience of cross-functional teamwork.
- Working knowledge of pharmacovigilance legislations worldwide.
- Competent team player with excellent networking and influencing skills.
- Ability to prioritise own workload, work under pressure and achieve strict timeline targets.
- Problem-solving approach – solution- and results-orientated.
- Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file.
- Fluency in English.
We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.
Global Asset Safety Lead in London employer: Meeveem Limited
Ipsen Biopharm Ltd is an exceptional employer that prioritises employee well-being and fosters a collaborative work culture, making it an ideal place for professionals seeking to make a meaningful impact in the biopharmaceutical industry. With a strong focus on patient outcomes and innovative solutions, employees are empowered to grow and thrive in their careers while contributing to transformative medicines that address unmet medical needs. Located in a dynamic environment, Ipsen offers unique opportunities for professional development and bold leadership, ensuring that every team member can play a vital role in shaping the future of healthcare.
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We think this is how you could land Global Asset Safety Lead in London
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We think you need these skills to ace Global Asset Safety Lead in London
Some tips for your application 🫡
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Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Meeveem Limited that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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