Development Physician (Medical Director) - Oncology

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Description Development Physician (Medical Director) - OncologyAbout Astellas:At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. 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. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit. 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. 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. We believe this will optimise 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. 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 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.
  • 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.
    • Essential Knowledge & Experience:
  • 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.
    • Additional information:
  • This is a permanent full-time position.
  • This position is based in the UK.
  • This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our 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, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-London#LI-Hybrid#LI-CC1
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    Location:
    Gb
    Job Type:
    FullTime

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