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.
The Opportunity:
As the Development Physician (Medical Director) you will be a core member of the clinical team, responsible for the design and execution of clinical trials, whilst serving as a Medical Monitor with oversight of safety monitoring and documentation.
This role supports efficient trial execution and high-quality data collection to guide strategic decisions, contributing to clinical development initiatives, and providing scientific and medical training to internal and external stakeholders.
This role reports to the Global Medical Portfolio Lead for Late Oncology and is located in Bourne, UK.
Hybrid Working:
At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Key Responsibilities:
- Serving as a Medical Monitor with responsibility for safety monitoring on clinical studies. Generating safety related documents, such as medical monitoring reports. Collaborating closely with the safety officer in writing and/or reviewing safety narratives, investigator letters, and other safety documentation for site-reported safety events.
- Partnering with Development Scientists responsible for the medical aspects of all study-related documents, including for example the clinical study protocol, informed consent forms, clinical database, safety committee charters and clinical study reports.
- Working with Development Scientists and Clinical Operation Leads to ensure efficient and streamlined execution of clinical trials and acquisition and interpretation of high-quality clinical data to inform program-level decision making and overall development strategies.
- Supporting functional level clinical development related initiatives as needed. Leading and/or participating in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies.
Essential Knowledge & Experience:
- Experience working within the pharmaceutical industry specifically in clinical trial design and execution in a bio-pharmaceutical development organisation or a balance of experience at an academic institution and a pharmaceutical company.
- Excellent verbal and written communication skills in English.
- Experience working in global teams and a global matrixed, remote working environment.
- Aware of cultural diversity and how to influence and manage in a multi-cultural organisation.
- Highest level of scientific integrity and impeccable work ethics.
Preferred Experience:
- Board certified in Oncology or Oncology-related specialty
- Experience in solid tumours, preferably Gastro-Intestinal, Thoracic or Genito-Urinary
- Experience in all phases of Clinical Development and interfaces with Drug Discovery through Marketing.
- Direct experience leading global regulatory marketing authorisation submissions and defense of those submissions
Education:
- MD or MD/PhD, or equivalent.
Additional information:
- This is a permanent full-time position.
- This position is based in the UK.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local 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.
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