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Astellas Pharma

Astellas Pharma

www.astellas.com

6 Jobs

11,661 Employees

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-guidelines

Listed Jobs

Company background Company brand
Company Name
Astellas Pharma
Job Title
Site Contract Manager
Job Description
**Job Title** Site Contract Manager **Role Summary** Oversee the review, negotiation, and execution of global clinical site contracts for pharmaceutical or biotech clinical trials. Ensure contracts meet regulatory, legal, and data‑privacy requirements and are delivered on schedule. Collaborate with internal stakeholders (legal, privacy, ethics, clinical operations, medical affairs) and external parties (investigator sites, CROs) to maintain best‑practice processes and templates. **Expectations** - Deliver compliant site agreements that support project timelines and risk management. - Maintain and improve SOPs, contract playbooks, and template libraries. - Provide clear, actionable legal guidance and training. - Contribute to strategic improvement projects and industry best‑practice adoption. **Key Responsibilities** - Review and negotiate individual and master clinical trial agreements for insourced and outsourced sites. - Identify and manage contract risks, escalating issues to appropriate leaders. - Update and standardise global contract templates and processes in line with evolving regulatory and legal environments. - Liaise between site contract negotiators and legal partners to ensure timely, strategic advice. - Draft and deliver guidance documents, training, and updates on contract policies. - Participate in continuous improvement initiatives for contract management. - Monitor regulatory changes (e.g., GDPR, ICH/GCP) and incorporate them into contract practices. **Required Skills** - Extensive experience in global pharma/biotech contract or budget management. - Strong understanding of regulatory, legal, and data‑privacy issues in pharmaceuticals. - Ability to analyse complex legal and regulatory requirements and provide pragmatic solutions. - Excellent negotiation, communication, and stakeholder‑management skills. - Proficiency in drafting, editing, and maintaining legal documents and SOPs. **Required Education & Certifications** - BA/BS in Life Sciences or equivalent. - Knowledge of ICH/GCP guidelines and regulatory requirements. - Familiarity with GDPR and other data‑privacy laws. **Preferred Experience** - Prior paralegal or legal role in pharma/biotech. - Experience managing teams or leading projects.
Addlestone, United kingdom
Hybrid
11-11-2025
Company background Company brand
Company Name
Astellas Pharma
Job Title
Information Security Operations Lead
Job Description
**Job Title** Information Security Operations Lead **Role Summary** Lead and manage a global Security Operations Center (SOC) to ensure continuous monitoring, detection, and response to cyber threats. Oversee enterprise security domains—endpoint protection, email security, vulnerability management, and attack surface reduction—while aligning operations with industry frameworks (NIST CSF, ISO 27001). Build and direct a hybrid team of full‑time staff, contractors, and managed services to achieve operational excellence and risk mitigation across the organization. **Expectations** - Deliver proactive threat detection and rapid incident response at a global scale. - Maintain and enhance the security technology stack (SIEM, SOAR, EDR, threat‑intel platforms). - Foster collaboration across security, IT, and business units to support risk management objectives. - Demonstrate measurable improvements in security posture through metrics and reporting. **Key Responsibilities** - Oversee daily SOC operations, ensuring 24/7 monitoring, triage, and remediation. - Manage and coordinate endpoint, email, vulnerability, and attack‑surface security programs. - Lead a hybrid team comprising employees, contractors, and managed‑services providers, defining roles, accountability, and performance metrics. - Maintain and optimize security technologies (SIEM, SOAR, EDR, threat‑intel). - Align SOC activities with enterprise frameworks (NIST CSF, MITRE ATT&CK, ISO 27001) and internal risk policies. - Develop incident response playbooks, conduct tabletop exercises, and drive continuous improvement. - Report on security metrics, incident trends, and program effectiveness to senior leadership. **Required Skills** - Proven leadership in global security operations and SOC management. - Expertise with SIEM, SOAR, EDR, and threat‑intel platforms. - Deep understanding of NIST CSF, MITRE ATT&CK, and incident‑response methodologies. - Strong communication, influencing, and cross‑functional collaboration abilities. - Experience managing mixed teams (employees, contractors, managed services). **Required Education & Certifications** - Bachelor’s degree in Computer Science, Information Security, or related field. - Professional certifications: CISSP, CISM, GIAC, or equivalent highly preferred.
Addlestone, United kingdom
Hybrid
Senior
12-11-2025
Company background Company brand
Company Name
Astellas Pharma
Job Title
Project Manager Diagnostic
Job Description
**Job title:** Project Manager – Diagnostic (PMDx) **Role Summary:** Lead and deliver complex precision‑medicine diagnostic projects, ensuring alignment with drug development programs, budgets, timelines, and regulatory requirements. Act as the primary point of contact for cross‑functional teams and external vendors, driving project execution, risk mitigation, and process improvement. **Expectations:** - Own end‑to‑end project lifecycle for 4–8 diagnostic studies per program. - Maintain independent decision‑making and proactive risk management. - Deliver projects on schedule and within approved budgets. - Communicate progress and issues to global leadership in a matrixed environment. **Key Responsibilities:** - Develop, update, and maintain detailed project plans, schedules, and resource allocations for drug‑paired diagnostic studies. - Forecast, track, and reconcile project budgets, purchase orders, and invoices in partnership with finance and procurement. - Negotiate, monitor, and assure compliance of PMDx contracts and vendor agreements. - Lead internal and external project meetings, set agendas, record minutes, and track action items. - Centralize and manage documentation for PMDx activities across all drug programs and clinical studies. - Identify, analyze, and mitigate project risks to ensure successful diagnostic delivery. - Foster relationships with internal stakeholders (Development, Lab Operations, Clinical Science, Data Science, Regulatory Affairs, Translational Medicine) and external partners (vendors, payers, regulatory authorities). - Drive continuous improvement of project management processes, tools, and templates. - Mentor junior Diagnostic Project Managers as needed. - Support companion diagnostic launch preparations in coordination with Medical Affairs and Commercial teams. **Required Skills:** - Proven experience leading complex projects in pharmaceutical, biotech, or R&D settings. - Strong project management methodology knowledge (e.g., PMBOK, Agile, Six Sigma). - Expertise in resource planning, budget forecasting, and financial oversight. - Excellent communication, stakeholder management, and negotiation skills. - Analytical mindset for risk assessment and problem solving. - Ability to work independently and manage multiple priorities in a matrixed structure. **Required Education & Certifications:** - Bachelor’s degree in life sciences, chemistry, pharmacy, engineering, or related field. - Project Management Professional (PMP) or equivalent certification strongly preferred. ---
Addlestone, United kingdom
Hybrid
28-11-2025
Company background Company brand
Company Name
Astellas Pharma
Job Title
Study Start-Up / Site Activation Specialist
Job Description
**Job Title** Study Start‑Up / Site Activation Specialist **Role Summary** Serve as a local subject‑matter expert for Study Start‑Up (SSU) activities. Coordinate and manage site activation tasks across the clinical pipeline, ensuring adherence to GCP/ICH regulations, efficient documentation, and timely completion of deliverables. Interface with study teams, regulatory bodies, and cross‑functional stakeholders to facilitate smooth site onboarding and data collection. **Expectations** - Operate under Clinical Operations Excellence framework with no direct reports. - Ensure all SSU actions comply with GCP, ICH guidelines, and regulatory requirements. - Maintain accurate, real‑time project status and financial information in tracking systems. - Escalate issues promptly and collaborate with global SSU managers to resolve obstacles. **Key Responsibilities** - Oversee end‑to‑end site‑level SSU activities: site list intake, IRB/EC submission, informed consent form negotiation, Investigator/Study Coordinator agreements, IMP release, and related documentation. - Generate and maintain accurate project status and financial data within established tracking tools. - Prepare study‑level essential document templates and support regulatory submission content. - Conduct ICF negotiations and manage related escalations. - Coordinate with IT/IS and other functions to ensure clinical systems (e.g., CTMS) are properly utilized for forecasting and data capture. - Provide administrative support for clinical system usage within Clinical Operations. - Maintain knowledge of local SSU policies and adapt processes accordingly. **Required Skills** - Fluency in English; proficiency in Italian or German (Spanish or French encouraged). - Extensive experience in clinical trial conduct, including SSU processes and requirements. - Strong project management and organizational skills. - Excellent written and verbal communication, with ability to coordinate across matrixed teams. - Sound understanding of drug development lifecycle, ICH/GCP guidelines, and regulatory submissions. - Proficiency with clinical trial management systems (CTMS) and related data entry tools. **Required Education & Certifications** - BA/BS in Life Sciences or related field (equivalent). - GCP certification or equivalent regulatory training (preferred).
Addlestone, United kingdom
Hybrid
01-12-2025