Development Physician, Medical Director, Oncology

Description

Development Physician, Medical Director, Oncology

About Astellas

At Astellas we are making treatments that matter to people.

We are tackling the toughest health challenges putting the patient at the heart of every move we make.

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 have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.

We take a 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 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.

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.
• 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 tumors.
• 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.