Clinical Development Physician Medical Director Oncology GB, KTNX

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at  .

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

This role reports to the Global Medical Lead, Oncology Development. This is a hybrid position and will require you to be onsite 1 day per quarter at Bourne office in London, UK.

At Astellas we recognize 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 optimize 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.

As the Development Physician (Medical Director) you will be responsible for overseeing the design and delivery of clinical trials across a late-phase program or multiple early-phase programs within the Immuno-Oncology group.

Reporting to the Medical Lead, you are accountable for defining the strategy and ensuring the successful execution of assigned studies. As a clinical team leader, you have a clear understanding of your responsibilities and accountabilities and provide leadership across cross-functional teams.

You are a collaborative team player who is comfortable acting as a consultant and providing support to other functions, particularly within the asset team. You also recognise the importance of effective information and knowledge management, strong partnerships, and cross‑functional collaboration in driving successful drug development programs.

• Collaborates 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.
• Serves as Medical Monitor w/ responsibility for safety monitoring. Ensures patient safety on clinical study is maintained. Generates safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete. Collaborates closely with safety officer in writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site‑reported safety events.
• Coordinates with 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.
• Able to 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.
• Responsible for managing the process of development of protocol and necessary regulatory documents.
• Accountable and responsible for development and implementation, and execution of clinical trials as part of a large complex late phase (post…