Description Study Start-Up / Site Activation Lead (Associate Director)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.
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
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.
#J-18808-Ljbffr