Clinical Development Physician, Director
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing 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 you will join a diverse and agile team and be responsible for overseeing the design and delivery of trials within a given late phase program or multiple early-phase programs in the Immuno-Oncology (IOD) group. As one of the Clinical team leads you will act as a consultant and provide support to other functions and particularly the asset area and understand the criticality of information and knowledge management, partnership and collaboration required in drug development.
This role is accountable for defining the strategy and execution of assigned trials for the given program(s) and reports to the Medical Head, IOD, Oncology Development.
This position can be based in the UK, EU4 major markets or Mexico City, Mexico.
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:
- Collaborating 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.
- Serving as Medical Monitor with responsibility for safety monitoring. Ensuring patient safety on clinical study is maintained. Generating 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.
- Coordinating 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.
- Managing the process of development of protocol and necessary regulatory documents. Serving as the clinical interface in regulatory authority interactions.
- Being 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. In earlier phases, serves as the clinical lead for the entire clinical development strategy and execution for a given program.
Essential Knowledge & Experience:
- Extensive pharmaceutical industry experience 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.
- Proven record of designing clinical trials that can produce high quality data in a timely manner for decision making.
- Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations.
- Experience working in global teams and a global matrixed, remote working environment.
- Direct experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.
Preferred Qualifications:
- Board certified with patient treatment experience beyond fellowship preferred.
- Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumors
- 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
Education:
- Medical qualification such as MD or equivalent with experience treating patients with a current or prior license to practice.
Additional information:
- The is a permanent full-time position.
- This position can be based in the UK, EU4 major markets or Mexico City, Mexico.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week 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.
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