Overview
Development Physician / Medical Director - Oncology at Astellas Pharma. This role is located in Bourne, UK with hybrid working and remote options available.
Description
About Astellas: At Astellas we are making treatments that matter to people. We focus on patient-centric development and aim to turn early science into life-changing solutions.
Opportunity and Responsibilities
* As the Development Physician (Medical Director), oversee the design and delivery of trials within a given late-phase program or multiple early-phase programs in the Immuno-Oncology group.
* Lead the clinical study team, manage knowledge management, partnerships, and collaboration required in drug development.
* Report to the Medical Lead for the program and define the strategy and execution of assigned trials; role located in Bourne, UK.
* Support hybrid/remote working arrangements to balance work and home life.
* Collaborate with 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; generate safety-related documents (e.g., medical monitoring reports) and ensure SAE reporting is current and complete. Partner with the safety officer on safety narratives, investigator letters, and other safety documentation for site-reported events.
* Coordinate with the Safety Officer on program for benefit-risk assessments, FIH dose selection, escalation path for early-phase programs, safety management on trials, input on clinical documents, statistical analysis plans, interim/final analyses, publications, CSRs, DSURs, and other critical documents.
* Manage development of protocols and regulatory documents as required.
* Integrate input from Research, Clinical Pharmacology, Biomarker, medical safety, Toxicology, biostatistics, medical affairs, Health Economics, and commercial perspectives into clinical development strategies and trial designs.
Essential Knowledge & Experience
* Experience in development, implementation, and execution of clinical trials as part of a large, complex late-phase program or multiple early-stage programs, aligned with asset and overall clinical strategy.
* Experience managing clinical trial budgets and timelines; providing advice on scientific/clinical, technical aspects that may impact development timelines and budgets.
* Regulatory interface experience; accountable for development and execution of clinical trials within a large complex late-phase or group of earlier-stage programs.
* Design of scientifically rigorous, cost-effective, patient-centric trials in accordance with the Clinical Development Plan; co-ordination of protocol, ICF, and related documents with development scientists, clinical operations, medical writing, and regulatory.
* Extensive experience in the pharmaceutical industry in clinical trial design and execution within a global, matrixed, remote-working environment.
* Experience planning and managing trials, serving as medical monitor, and coordinating trial execution with clinical operations.
Preferred Experience
* Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumours.
* Clinical research experience in an academic setting.
* Experience across all phases of Clinical Development with interfaces from 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 and follows a hybrid working model. Role requires a blend of home work 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, color, 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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