Clinical Operations Lead
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 Clinical Operations Lead, you will be responsible for effective planning, oversight, and execution of Clinical Development Plans and pre/post-POC trials for assigned assets and due diligence projects as well as ensuring expert clinical operations strategy input is provided to Primary Focus Area and/or Asset Teams.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Responsibilities:
Develop clinical program budgets and resource estimates for assigned assets and due diligence projects
Provide oversight of budget and resources during the execution of clinical trials
Provide oversight and guidance to extended team members in completing program deliverables according to agreed timelines and quality standards, including awareness and escalation of high-impact quality-related topics for assigned programs
Participate in and/or facilitate cross-functional collaboration and strategic problem-solving to ensure risk mitigation, appropriate progress, and timely completion of trials and deliverables according to established objectives, milestones, and goals.
Essential Knowledge & Experience:
Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives.
Strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
Demonstrated ability to successfully identify and lead global process or system improvement initiatives.
In-depth knowledge of clinical development processes and conducting global clinical programs
Previous experience working across multiple phases of development and in multiple therapeutic areas.
Excellent leadership skills and effective written and verbal communication skills
Fluent in written and spoken business English.
Preferred Knowledge & Experience:
Direct people management experience
Education/Qualifications:
Bachelor's degree or equivalent.
Additional Information:
This is a permanent, full-time position.
This position can be based in the United Kingdom, Spain, or any other European country.
This position follows our hybrid working model. Role requires a blend of home and office working. The number of days in the office will depend on the location. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
We offer:
A challenging and diversified job in an international setting
Opportunity and support to continuous development
Inspiring work climate
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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