Astellas Pharma Inc.

• An exciting opportunity to contribute to pivotal trial launches and new programs, where we welcome fresh ideas and innovative ways of working — giving you the chance to share your expertise and make a meaningful impact on our processes.
• In this role, you will be responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
• Be accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.
• The position has no direct reports but may provide oversight and direction to trial team members for trial deliverables.

• Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Lead or support cross-functional trial teams, including vendors.
• Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders.
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.
• Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data.
• Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team.
• Participate in or lead feasibility assessment and selection of countries and sites for trial conduct.
• Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables.

• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
• Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members.
• Provide oversight and direction to trial team members for trial deliverables.
• Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems.
• Ensure quality and completeness of TMF for assigned clinical trials.
• Participate in inspection readiness activities including coordination of clinical trial team deliverables.
• Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable.
• Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities.

• A BA/BS degree with proven clinical trial experience, OR an advanced degree (MS/PhD/PharmD) with relevant hands-on clinical trial experience.
• Must have Oncology therapeutic area experience
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
• Requires project management skills and trial leadership ability.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Study management experience is key.
• Fluent in English.
• Moderate (~25%) travel required.

• Ability to thrive in a collaborative, cross-functional environment — working effectively with a range of teams, roles, and personalities.
• Comfortable to also work independently, showing initiative and resourcefulness to problem-solve and exchange ideas with colleagues.
• Flexibility and the ability to manage multiple priorities

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus

Careers | Astellas