Astellas Pharma Inc.

• You will be accountable for the oversight and execution of assigned pre/post-POC interventional drug programs, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
• Be accountable to the Portfolio Operations Lead and clinical operations leadership team and will provide input into budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and mentoring and coaching of staff during execution of development trials.
• The position has accountability for assuring strategic input and operational insight into the asset development planning lifecycle, including integrated evidence generation (iEGP), Global Development Plan (GDP), Clinical Development Plan (CDP) and the implementation of patient-focused strategies for assigned programs.
• Individuals may serve in regional capacity to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions and submissions to Health Authorities within their region/country of responsibility.
• The position may also represent Clinical Operations in due diligence activities for assets that may be in-licensed or acquired.
• Reporting to the Portfolio Operations Lead (or above), you will lead a global team of 2 - 3 direct reports, including international team members.

• Seasoned experience executing complex global drug development programs and trials.
• Demonstrated experience working in late-stage development.
• Current or previous experience within the Oncology therapeutic area is essential.
• Must have strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
• Demonstrated ability to successfully identify and lead global process or system improvement initiatives.
• Must have a strong knowledge of clinical development processes and conducting global clinical programs.
• Moderate (~25%) travel required, depending upon assigned program and phase.

• Responsible for effective planning, oversight, and execution of Clinical Development Plans and pre/post-POC trials for assigned assets and due diligence projects.
• Ensure expert clinical operations strategy input is provided to Primary Focus Area and/or Asset Teams.
• Develop clinical program budgets and resource estimates for assigned assets and due diligence projects.
• Provide oversight of budget and resources during execution of clinical trials.
• Provide oversight and guidance to extended team members in completing program deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned programs.
• Provide input on clinical operational matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally, as applicable

• BA/BS Degree or an Advanced Degree or equivalent.

• 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