DescriptionClinical Transparency LeadAbout Astellas: At Astellas, experience is coupled energised with a relentless challenger spirit. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation. We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers. We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients. Hybrid Working: At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver. The Opportunity: As a Clinical Transparency Lead at Astellas Pharma, you will play a pivotal role in overseeing and executing clinical transparency processes for our global studies. You will contribute to the development of innovative therapies that tackle unmet medical needs, ensuring that our commitment to transparency and ethical standards is upheld. Join us in our mission to "Change Tomorrow™" and be part of a team that values your growth as much as it does patient care. Key Responsibilities:
Oversee and execute the clinical transparency processes for assigned studies, ensuring compliance with all applicable laws and regulations. Provide training and share expertise in clinical transparency activities, fostering a culture of knowledge and accountability. Monitor global regulatory requirements and communicate changes to team members, ensuring everyone is informed and aligned. Manage the review and approval process for clinical trial registrations and results disclosures on relevant databases. Facilitate periodic reviews of active registrations to ensure records are updated and compliant with evolving requirements.
Essential Knowledge & Experience: Collaborative approach with internal teams and external stakeholders to gather appropriate information to register, ensuring compliance with transparency regulations. Manage the publication of clinical trial results, ensuring appropriate and secure sharing of clinical trial data. Experience from within a pharmaceutical or healthcare related environment. Excellent organizational skills with a high attention to detail. Self-directed and motivated, with the ability to work independently and manage multiple tasks effectively. Preferred Experience: Ideally from within clinical trials, including study management, statistics, medical writing, and/or data management. Working knowledge of clinical drug development and clinical trial protocols. Education: Bachelor's Degree or equivalent experience. Additional Information: This is a permanent, full-time position. This position is based in the United Kingdom. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Addlestone office. Flexibility may be required in line with business needs. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Addlestone#LI-Hybrid
