Manager, Clinical Transparency
About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
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.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
About this job:
As the Manager of Clinical Transparency, your role is pivotal in overseeing and executing the clinical trial disclosure process for assigned studies conducted by Astellas globally. You will play a key part in ensuring compliance with clinical trial disclosure laws, industry guidance, and corporate policy. Your responsibilities also include providing training, sharing expertise, and contributing to the establishment and refinement of clinical trial disclosure processes.
Hybrid working:
At Astellas we recognize that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
In this role, you will:
- Assess requirements for clinical trial registration or disclosure of results.
- Prioritize, oversee, and perform the day-to-day operations of clinical trial disclosure for timely completion, review, and approval of registration and results disclosure activities globally.
- Make appropriate decisions on the applicability and timing of clinical trial disclosure activities.
- Manage the review and approval process for clinical trial registrations and results disclosures, communicating effectively with partner companies or collaborators.
- Facilitate periodic reviews of active registrations to ensure records are updated or verified as required.
Essential Knowledge & Experience:
- Proven experience in the pharmaceutical industry.
- Excellent organizational skills and high attention to detail.
- Self-directed and motivated, with the ability to work without significant direct supervision.
- Proficient computer skills, including experience with MS Word and Excel.
- Ability to provide training to clinical transparency team members and educate study team members and other organizational contacts on clinical trial disclosure policies and processes.
Preferred Knowledge & Experience:
- Clinical trials experience, including study management, statistics, medical writing, and/or data management.
- Working knowledge of clinical drug development and clinical trial protocols.
Education:
- Bachelor's degree in a relevant field or equivalent.
Additional information:
- This is a permanent, full-time position
- 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. Candidates must be located within a commutable distance of the office.
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.