Astellas Pharma

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 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 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

Company Name

Astellas Pharma

Job Title

Legal Partner, R&D Transactions

Job Description

**Job Title** Legal Partner, R&D Transactions **Role Summary** Provide expert legal counsel for all R&D‑related transactions, including research collaborations, clinical and non‑clinical studies, manufacturing, supply, data sharing, consulting and service agreements. Draft, negotiate and execute complex agreements while ensuring regulatory compliance, risk mitigation, and strategic alignment across research, technology & manufacturing, development, medical affairs, and Rx+ functions. **Expectations** - Deliver strategic, timely, high‑quality legal support aligned with global objectives. - Balance regional regulatory requirements and mitigate legal risk. - Keep leadership informed on legal and regulatory developments. - Contribute to contract process improvements (templates, checklists). - Manage outside counsel and legal spend efficiently. - Support special projects and travel internationally as required. **Key Responsibilities** - Draft, negotiate and execute complex R&D agreements (collaborations, studies, manufacturing, data sharing, consulting). - Advise business partners on legal implications of strategic projects. - Ensure compliance with pharmaceutical, biotechnology, and medical device regulatory requirements (patent, trademark, licensing, anti‑kickback, fraud, abuse, anti‑bribery). - Develop and maintain contractual templates, checklists, and guidance materials. - Coordinate with Legal Transactions Tower, Legal Functional Unit, and GC & CECO Division. - Oversee outside counsel, manage legal budgets, and optimize spend. - Support international R&D initiatives and travel as needed. **Required Skills** - 5+ years of legal practice in a law firm or pharmaceutical legal department. - Proven experience drafting, negotiating and executing complex R&D agreements. - Strong knowledge of pharma/biotech/medical device legal landscape (IP, regulatory, anti‑kickback/corruption). - Ability to analyze regulatory environments and translate them into contractual risk mitigation. - Excellent negotiation, drafting, and communication skills. - Collaborative mindset, working effectively with cross‑functional teams. - High level of organization and project management. **Required Education & Certifications** - Bachelor of Laws (LL.B.), Juris Doctor (JD), Master of Laws (LL.M.) or equivalent. - Active bar membership in the relevant jurisdiction. - Science degree or background in chemistry/biology is advantageous.

Addlestone, United kingdom

Hybrid

01-12-2025

Company Name

Astellas Pharma

Job Title

Clinical Trial Manager

Job Description

**Job Title** Clinical Trial Manager **Role Summary** Lead the planning, set‑up, and execution of assigned drug trials, ensuring operational excellence and regulatory compliance. Manage day‑to‑day trial activities, coordinate cross‑functional teams and vendors, oversee documentation, training, and budget, and maintain accurate trial tracking to meet project goals within GCP/ICH guidelines. **Expectations** - Deliver trial operations in accordance with EU‑CTR, ICH/GCP, and sponsor SOPs. - Achieve project milestones, quality standards, and budget targets. - Act as primary point of contact for site, vendor, and internal stakeholders. - Facilitate inspections and support regulatory submissions. **Key Responsibilities** - Manage day‑to‑day operations of multiple interventional and non‑interventional trials, ensuring timely completion of deliverables. - Lead or support cross‑functional trial teams, including vendors, investigators, and site staff. - Design and deliver investigator and site monitor training; coordinate therapeutic area training for internal and external teams. - Develop core trial documents (protocols, plans, site communications), system set‑ups, and operational checklists. - Maintain up‑to‑date trial information in tracking systems; provide regular status reports to Clinical Operations Lead, Trial Lead, and stakeholders. - Define vendor requirements, scope, and selection; manage vendor contracts, escalations, and performance. - Monitor and control trial budgets, capturing cost data within management systems. - Ensure readiness for inspections and audits, coordinating deliverables and corrective actions. **Required Skills** - Proven EU‑CTR and in‑sourced study management experience. - Deep knowledge of clinical drug development, trial design, planning, and monitoring. - Strong project management and leadership abilities. - Expertise in GCP/ICH guidelines and regulatory requirements. - Vendor management and contract negotiation skills. - Budget management and financial oversight. - Excellent written and verbal communication; stakeholder liaison. - Ability to develop training materials and conduct training sessions. **Required Education & Certifications** - Bachelor’s degree (or equivalent) in life sciences, clinical research, or related field. - ICH/GCP training or equivalent regulatory training preferred. **Preferred Experience** - Sponsor‑side experience in Oncology, Rare Diseases, Gene Therapy, or Pediatrics. - Demonstrated vendor‑management experience in clinical trials. - Experience with inspection readiness and regulatory submissions.

Addlestone, United kingdom

Hybrid

02-12-2025