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About Astellas
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
Description
Clinical Operations Lead I
We pursue innovative science, focusing on areas of high potential and developing solutions for high-need, often in rare or underserved diseases and conditions.
We work directly with patients, doctors, and healthcare professionals to ensure patient and clinical needs guide our development activities at every stage.
Our vision for Patient Centricity is to support innovative health solutions through a deep understanding of the patient experience, fostering a patient-centric culture across all roles.
We collaborate with regulatory authorities and payers to ensure access to therapies, providing insights and real-world evidence to inform decisions and improve standards of care.
The Opportunity
As a Clinical Operations Lead (Associate Director), you will oversee strategic input and operational insights into asset development, impacting therapies that change lives. You will collaborate with cross-functional teams, managing budgets and navigating complex regulatory environments.
This role reports to the Portfolio Operations Lead and can be based in the UK or US.
Hybrid Working
We offer flexibility to work from home or in the office, requiring at least 1 day per quarter in the local office, with some flexibility based on business needs.
Key Activities
1. Oversee the Integrated Evidence Generation Plan (iEGP), Global Development Plan (GDP), and Clinical Development Plan (CDP).
2. Represent Clinical Operations in asset teams and process improvement projects.
3. Manage departmental budgets and resources, ensuring compliance and quality.
4. Guide and oversee team members, fostering excellence and accountability.
5. Act as a regional representative for KOL interactions and Health Authority communications.
Essential Knowledge & Experience
* Extensive experience in global drug development, preferably in ophthalmology or related fields like cell and gene therapy or rare diseases.
* Strong leadership and cross-functional collaboration skills.
* Deep knowledge of ICH/GCP guidelines and multinational trial regulations.
* Proven experience in leading process or system improvements.
* Excellent communication skills in English.
Preferred Experience
* Experience in Phase 3 and late-stage development.
* Ability to work across time zones and travel up to 25% internationally.
* People management experience is highly desirable.
Education
* Bachelor’s degree or equivalent.
Additional Information
* Permanent, full-time position.
* Based in UK or US with hybrid work model.
* Role requires a mix of home and at least 1 day per quarter in the office, with flexibility based on needs.
We are an equal opportunity employer, considering all qualified applicants without regard to race, religion, gender, or other protected characteristics.
Job Details
* Senior level, Mid-Senior level
* Full-time management role in pharmaceutical manufacturing
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