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 a Study Start-Up / Site Activation Lead you will be responsible for the for the direct management of assigned study start-up related staff across all clinical trial types, which may include pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
You will be responsible for identifying, onboarding, training, and developing study start-up talent to support the planning, initiation, and execution of clinical trials with a focus on operational excellence. In addition, you will provide leadership and mentorship within a matrix environment to support clinical trial teams.
Your role will also involve contributing to departmental budgeting and resourcing strategies, helping to shape and implement global processes and procedures, supporting non-drug product initiatives, and coaching staff throughout the execution of development trials.
This position sits within Clinical Operations Excellence (COE) and will report into the Head, Study Start-up and is based in the UK.
Hybrid Working:
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
Key Responsibilities:
- Providing oversight and guidance in completing study start-up related activities according to agreed timelines and quality standards, including identifying areas for additional training and development
- Leading and managing study start-up teams, including recruitment, resource planning, mentoring, performance monitoring, and retention of staff. Providing functional leadership and management globally of < 12 direct reports
- Ensuring operational excellence, overseeing adherence to timelines, standards, and processes, while serving as a point of escalation for study start-up issues.
- Driving staff development, providing leadership, learning opportunities, and ensuring compliance with training requirements.
- Collaborating cross-functionally and globally, supporting process improvements, aligning on best practices, and contributing to the development of study start-up standards and tools.
Essential Knowledge & Experience:
- Extensive study start-up activities and direct people management 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 clinical development processes and conducting global clinical programs.
- Significant experience executing global drug development programs and trials.
- Extensive expertise in study start-up strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
- Experienced working across multiple phases of development and in multiple therapeutic areas.
Education:
- BA/BS degree life science or equivalent.
Additional Information:
- This is a permanent full-time position.
- This position is based in the United Kingdom.
- 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.
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