Development Physician, Immuno-Oncology Department

Development Physician, Immuno-Oncology Department

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity:

As the Development Physician (Senior 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.

Key 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.
• To serve as Medical Monitor with responsibility for safety monitoring whilst ensuring patient safety on 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 safety officer in writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
• Will co-ordinate 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.
• 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.
• Be responsible for managing the process of development of protocol and necessary regulatory documents.

Essential Knowledge & Experience:

• Will be 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.
• 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.
• Be accountable for 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.
• To serve 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.
• Will design scientifically rigorous, cost-effective, and patient-centric clinical trials in accordance with the Clinical development Plan.Be accountable 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.

Preferred Experience:

• Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumours.
• Prior clinical research experience in an academic setting
• Experience in all phases of Clinical Development and interfaces with Drug Discovery through Marketing.
• Direct experience leading global regulatory marketing authorization submissions and defense of those submissions.
• Responsible for managing the process of development of protocol and necessary regulatory documents.

Education/Qualifications:

• MD or PhD or equivalent.
• 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.
• Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations.
• Proven record of designing clinical trials that can produce high quality data in a timely manner for decision making.
• Experience working in global teams and a global matrixed, remote working environment.

Additional Information:

• This is a permanent, full-time position.
• This position is 100% home / remote based.
• This position can be based in the UK or Canada (except Quebec). Candidates interested in remote work are encouraged to apply. Remote work permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

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.