Global Evidence Generation Operations Lead
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 a Global Evidence Generation Operations Lead at Astellas Pharma, you will play a pivotal role in enhancing our Medical Affairs evidence generation activities. You will provide visibility and oversight of execution across various therapeutic areas, ensuring that our research initiatives are aligned with our mission to improve patient care globally. Your contributions will directly impact the planning and progress of research activities, making a meaningful difference in the lives of patients.
Hybrid Working:
At Astellas, we recognize the importance of balancing your work and home life. This role offers a remote working solution so you can optimize the most productive work environment for you to succeed and deliver.
Key Responsibilities:
- You will be an integral contributor to the Evidence Generation discussions at the Core Medical Affairs Team (CMT), identifying evidence gaps and assessing the feasibility of potential evidence generation activities.
- Collaborating with regional MA Evidence Generation Operations colleagues, you will oversee study execution and ensure on-time delivery of planned milestones while maintaining compliance and quality standards.
- You will set the operational strategy for evidence generation within your assigned therapeutic area, ensuring alignment with organizational goals.
- You must have strong strategic thinking with proven ability to innovate, manage complex projects and also lead day-to-day operations.
- You will manage the budget oversight for your therapeutic area, identifying opportunities for cost optimization and resource management.
- You will facilitate annual evidence generation planning activities, including new research proposals and revisions of ISR Areas of Interest.
Essential Knowledge & Experience:
- You should have extensive operations experience within the pharmaceutical industry, with a strong focus on clinical program management
- You must have demonstrable experience leading teams in project management, process improvement, or strategic planning.
- You will have substantial experience overseeing Evidence Generation activities, including MA-sponsored studies and collaborative research, along with budget management expertise.
Preferred Experience:
- Experience with regulatory submissions and compliance in clinical research.
- Familiarity with data analytics tools and methodologies.
- Ideally solid experience in both study and project management in a global context.
Education:
- Bachelor’s degree in sciences or equivalent experience.
Additional Information:
- This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
Astellas’ Global Capability Centres – Overview:
Astellas’ Global Capability Centre’s (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
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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