Job Specifications
Description
Site Contracts Manager
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 Site Contracts Manager, you will oversee the review and execution of global site contracts for Astellas clinical studies, including both individual and master-level Clinical Trial Agreements, across insourced and outsourced models. You will support Clinical Operations (and occasionally Medical Affairs), ensuring contracts comply with regulatory, legal, and data privacy standards.
You will play a key role in maintaining global best practices and ensuring contracts are delivered in line with project timelines and compliance requirements.
This role reports into the Site Contract & Budget Lead. It involves close collaboration with internal teams such as Legal, Data Privacy, and Ethics & Compliance, as well as external stakeholders like investigator sites and CROs. This position is based in the United Kingdom.
At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Responsibilities
Working with the site contract team to proactively identify, risk-manage, including escalation and resolve issues that arise with clinical site contracts.
Driving and/or contributing to the development and/or continuous update(s) to functional SOPs, Astellas Global Contract Negotiations Playbook and other relevant core processes and tools.
Serving as the liaison to collaborate between site contract negotiators and designated legal partners (as needed) to support development or update to global templates and processes to help ensure timely, proactive, strategic, best-in-class legal advice and support, taking into account objectives of the organization, and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk to the business.
Providing draft of guidance documentation(s) and training, as required. Managing the changes of the documents, templates or training under their purview. Participating in strategic improvement/innovation projects as requested.
Ensuring Industry Best Practice investigation and implementation.
Essential Knowledge & Experience
Extensive global biotech/pharma experience in legal, site contracts/budgets and/or related functional area
Good understanding of the regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to the core and country templates.
Strong ability to grasp regulatory and legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice.
Proven success in execution of strategies for relevant non-project support functions.
Strong knowledge of clinical development processes and ICH/GCP guidelines and regulatory requirements
Solid negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner.
Education/Qualification
BA/BS degree life science or equivalent.
Preferred Experience
Prior paralegal or legal experience
Direct people management experience preferred
Additional Information
This is a permanent full-t
About the Company
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Visit our Global Astellas LinkedIn Community Guidelines to learn more about interacting with this page: https://www.astellas.com/en/global-linkedin-community-...
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