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:
The role of Clinical Development Physician (Ophthalmology) is a new position created to support our evolving Clinical Development structure, supporting a strategic initiative for Accelerated Clinical Execution.
The role is a global position that will report to the Clinical Head of Cell & Gene Therapy with an initial focus on our new Ophthalmology Therapy Area.
As the Global Development Physician, you will be responsible for providing input into the design and conduct of clinical trials, reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assessing/interpreting safety data, and contributing to investigator, site staff and clinical study team training.
You will collaborate with the medical lead and a broad cross-functional team in Medical, Clinical Operations, Regulatory Affairs, Statistics, and Commercial.
As part of this role, you will also be responsible for reviewing images hence the need for experience in the field of Ophthalmology.
Key activities are noted below:
- Consult with internal and external stakeholders in the development of clinical trial design and conduct, including drafting of protocols and amendments. Provides review of protocols and on-going medical oversight of trials to ensure safety concerns and/or adverse events are identified, and responses are developed and executed
- Generates safety related documents, such as medical monitoring reports to ensure the safety database and the reporting of Serious Adverse Events (SAEs) is current and complete. Provides 24/7 emergency coverage for safety-related matters
- Advises on medical questions or issues throughout the clinical trial and reviews/analyses the eligibility of participants
- Develops and/or reviews operational, medical monitoring, and safety plans for all studies.
- Leads and/or participates in scientific and medical training of team members, external clients, investigators, and other site staff in relation to requirements for assigned studies.
Essential Knowledge & Experience:
- Solid experience of working in a CRO, pharmaceutical, or clinical trial environment as a Development Physician
- Direct experience of medical monitoring and pharmacovigilance or drug safety experience
- Experience of the Ophthalmology Therapy Area
- The ability to operate efficiently in a global matrix environment with experience of global/regional clinical trails
- Proficiency with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, drug development, clinical trials, and clinical research.
Education/Qualifications:
- Medical qualification such as MD or equivalent with current or prior license to practice. Additional qualification as an Ophthalmologist
Additional information:
- This is a permanent, full-time position based in the UK
- The position follows our hybrid working model with a blend of home and a minimum 1-day per quarter in our Addlestone office. Flexibility may be required in line with business needs. Candidates should be located within a commutable distance of a designated 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.