Site Contract & Budget Specialist
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 Site Contract & Budget Specialist, you will be responsible for the development, delivery, and negotiation of site contracts and/or budgets in line with global standards and regional requirements. The scope may include local and regional countries.
This position will work within the Site Contract & Budget function, reporting to the Site Contract & Budget Manager and working closely with members of the Site Contract & Budget function, including Site Payment, Legal, and Data Privacy. This position is based in Warsaw, Poland.
Hybrid Working:
At Astellas we recognize 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 Activities for this role:
- Coordinating work within the Site Contract & Budget support function to support both early- and late-stage Clinical Operations.
- Supporting negotiations with clinical investigator sites and others to facilitate master clinical trial agreements/clinical trial agreements, ensuring alignment with established Astellas legal positions.
- Assisting with budget negotiations with clinical investigator sites globally, including escalation review and implementation of global budget rate cards when applicable.
- Applying global best practices in alignment with relevant legal and data privacy requirements, supporting clinical trial execution in collaboration with Legal and Data Privacy teams.
- Ensuring timely and high-quality delivery of site/investigator clinical contracts and/or budgets, aligned with informed consent documents and legal language, while meeting compliance, regional, operational, and study timelines.
Essential Knowledge & Experience:
- Solid experience in pharmaceutical-related drug development or equivalent experience in handling contractual/transactional legal matters and/or site budget responsibilities.
- Proven knowledge of legal and data privacy issues in the pharmaceutical industry, including GDPR, regulatory processes, anti-kickback, anti-bribery, and antitrust laws.
- Demonstrable analytical problem-solving and decision-making skills, with sound judgment and practical feedback capabilities.
- Proficient in English and the primary language of the country of employment.
- Strong understanding of clinical development processes, ICH/GCP guidelines, and regulatory requirements.
Preferred Qualifications:
- Experience with both site contracts and budgets.
- Experience working cross-functionally and with external providers.
Education:
- BA/BS degree in life sciences or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in Warsaw (Poland)
- 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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