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About Astellas
At Astellas we are making treatments that matter to people. We tackle the toughest health challenges by putting the patient at the heart of every move we make. Our global vision for Patient Centricity supports the development of innovative health solutions through a deep understanding of the patient experience. Astellas believes all staff have a role to play in creating a patient‑centric culture and integrating awareness of the patient into everyday practice, regardless of role, team or division.
We have developed ground‑breaking, innovative medicines in immunology, oncology and urology. Our medicines extend and save the lives of cancer patients, enable transplantation, and improve quality of life for those with conditions where needs are often overlooked. From laboratory to clinic to patient, we focus on the most promising science, empower the best talent, and develop life‑changing solutions alongside the best partners.
Description
Development Physician / Medical Director, Oncology
The Opportunity
As the Development Physician (Medical Director), you will oversee the design and delivery of trials within a given late‑phase program or multiple early‑phase programs in the Immuno‑Oncology group. Working as part of a diverse, agile, and global development team, you will be the clinical team leader responsible for knowledge management, partnership and collaboration in drug development.
Report to the Medical Lead for the given program(s) and be accountable for defining the strategy and execution of assigned trials. Location: Bourne, UK.
Hybrid Working
At Astellas we recognise the importance of work/life balance. We offer a hybrid working solution that allows time in the office and work from home flexibility. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Key Responsibilities
* Collaborate effectively with key internal and external stakeholders as a member of the asset team and leader of the clinical study team to advance one or more clinical trials.
* Serve as Medical Monitor with responsibility for safety monitoring, generating safety related documents and ensuring patient safety on clinical study is maintained.
* Coordinate with the Safety Officer on program for benefit‑risk assessments, planning FIH study dose selection and escalation path for early‑phase programs, safety management on trials, and review of safety documentation for site‑reported safety events.
* Manage the process of protocol development and necessary regulatory documents.
* Assimilate research, clinical pharmacology, biomarker, medical safety, toxicity (early phase programs), regulatory, biostatistics, medical affairs, health economics, and commercial perspectives into clinical development strategies and trial designs.
Essential Knowledge & Experience
* Experience in development and execution of clinical trials in late‑phase (post‑POC, established market) or early‑stage programs, aligned with asset and overall clinical strategy.
* Managed clinical trial budgets and timelines, providing advice on scientific/clinical, technical areas that impact development timelines and regulatory review periods.
* Served as the clinical interface in regulatory authority interactions.
* Designed scientifically rigorous, cost‑effective, patient‑centric clinical trials in accordance with the Clinical Development Plan.
* Extensive experience in a pharmaceutical or bio‑pharmaceutical development organization or balance of academic and industry experience. Experience in global teams and matrixed, remote working environments.
* Documented experience in planning and managing clinical trials, serving as medical monitor, and managing trial execution with clinical operations.
Preferred Knowledge & Experience
* Extensive experience in gastro‑esophageal, thoracic oncology, or immuno‑oncology in solid tumours.
* Prior clinical research experience in an academic setting.
* Experience across all phases of clinical development and interfaces with drug discovery through marketing.
Education
* MD or PhD or equivalent.
Additional Information
* This is a permanent, full‑time position.
* This position is based in the UK.
* This position follows Astellas’ hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in the 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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn’s support team through LinkedIn Help.
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