Development Physician (Medical Director)

Astellas Pharma; Little Cawthorpe; Hybrid; GBP 80,000 - 120,000; Full time

Job summary

A global biopharmaceutical company is seeking a Development Physician (Medical Director) to oversee clinical trials in Immuno-Oncology. The ideal candidate will lead trial strategy and execution, ensuring patient safety while managing timelines and budgets. Candidates should have extensive clinical trial experience, with a focus on immuno-oncology or thoracic oncology. This role offers a hybrid working model to balance professional and personal life.

Benefits

Hybrid working model

Qualifications

• Extensive experience in clinical trial design and execution.
• Experts in immuno-oncology or thoracic oncology.
• Experience working in global teams and remote environments.

Responsibilities

• Oversee design and delivery of trials in Immuno-Oncology.
• Collaborate with internal and external stakeholders on clinical trials.
• Manage clinical trial budgets and timelines.

Skills

Clinical trial design

Safety monitoring

Stakeholder management

Regulatory document management

Clinical pharmacology

Education

MD or PhD or equivalent

Job description

patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life‑changing solutions alongside the best partners.

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 as required in drug development. This role reports to the Medical Lead for the given program(s) and is accountable for defining the strategy and execution of assigned trials and is located in Bourne, UK.

Hybrid Working : At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.

Responsibilities

• You will 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 whilst ensuring patient safety on the clinical study is maintained. You will generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete. Partner closely with the safety officer in writing and / or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site‑reported safety events.
• Will coordinate with the Safety Officer on program for appropriate benefit‑risk assessments, planning FIH study dose selection and escalation path for early‑phase programs, safety management on trials, provides clinical input and review of clinical documents, statistical analysis plans, interim and final analyses on trials, publications, CSRs, DSURs and other critical documents.
• Be responsible for managing the process of development of protocol and necessary regulatory documents.
• Will assimilate Research, Clinical Pharmacology, Biomarker, medical safety, Toxicology (early phase programs) regulatory, biostatistics, medical affairs, Health Economics, commercial perspectives into clinical development strategies and trial designs.
• Experienced in development and implementation, and execution of clinical trials as part of a large complex late‑phase (post POC, established market) program or a group of earlier‑stage programs, in alignment with Asset and overall clinical strategy.
• Managed clinical trial budget and timelines and for advice and decisions in scientific / clinical, technical areas that may impact development timelines including regulatory review periods, probability of success or budget extensions or overruns.
• Served as the clinical interface in regulatory authority interactions. Will be accountable and responsible for development and implementation, and execution of clinical trials as part of a large complex late‑phase (post POC, established market) program or a group of earlier‑stage programs, in alignment with Asset and overall clinical strategy.
• Designed scientifically rigorous, cost‑effective, and patient‑centric clinical trials in accordance with the Clinical development Plan. Held accountability for Clinical trial scope development and authoring of the protocol, IB, ICF as appropriate, in coordination with development scientists, clinical operations, medical writing and regulatory.
• Extensive experience working within the pharmaceutical industry specifically in clinical trial design and execution in a bio‑pharmaceutical development organization or a balance of experience at an academic institution and a pharmaceutical company. Working in global teams and a global matrixed, remote working environment.
• Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations.

Preferred Experience

• Extensive experience in gastroesophageal or thoracic oncology or immuno‑oncology in solid tumours.
• Prior clinical research experience in an academic setting.
• Experienced in all phases of Clinical Development and interfaces with Drug Discovery through Marketing.

Education

• MD or PhD or equivalent.