Clinical Development Physician (Medical Director) - Oncology

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.

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 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.

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. You are a collaborative team player who is comfortable acting as a consultant and providing support to other functions, particularly within the asset team.

Responsibilities:

• 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 with 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.
• Coordinates with Safety Officer on program for appropriate benefit-risk assessments, planning FIH study dose selection and escalation path for early-phase programs.
• 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 program or a group of earlier stage programs.
• Creates and maintains scientific/clinical networks and seeks external opinion leader as appropriate.
• Serves as the clinical interface during clinical advisory boards, investigator meetings, and interactions with opinion leaders.
• Accountable for clinical development milestones for their given trials.
• Works with Development Scientists and Clinical Operation Leads to ensure efficient and streamlined execution of clinical trials.
• Designs scientifically rigorous, cost-effective, and patient-centric clinical trials in accordance with the Clinical development Plan.
• Responsible for keeping medical lead, asset lead and Development Head informed on progress of trials, risks, planned/required mitigations, and changes to timelines and budgets.
• Supports clinical development related initiatives as needed.
• Leads and/or participates in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies.

Required Qualifications and Experience:

• MD or MD/PhD with oncology fellowship complete or equivalent.
• Extensive experience working within the pharmaceutical industry specifically in clinical trial design and execution.
• Proven record of designing clinical trials that can produce high quality data in a timely manner for decision making.
• Excellent verbal and written communication skills in English.
• Aware of cultural diversity and how to influence and manage in a multi-cultural organisation.

Preferred Experience:

• Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumors.
• Prior clinical research experience in an academic setting.
• Direct experience leading global regulatory marketing authorization submissions and defense of those submissions.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions.

Astellas is 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.