Director Clinical Operations Gene Therapy

About Astellas

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. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope:

• This position is 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).
• This position is 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.
• This 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.
• Represents pre/post-POC Clinical Operations in Asset Teams, Portfolio and Operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable.
• 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.
• This position may represent Clinical Operations in due diligence activities for assets that may be in-licensed or acquired.
• Report to Portfolio Operations Lead or above
• Provides functional leadership and management globally of 3 direct reports, including international direct reports.

Responsibilities and Accountabilities:

• Responsible for effective planning, oversight, and execution of Clinical Development Plans and pre/post-POC trials for assigned assets and due diligence projects.
• Ensures expert clinical operations strategy input is provided to Primary Focus Area and/or Asset Teams.
• Develops clinical program budgets and resource estimates for assigned assets and due diligence projects.
• Provides oversight of budget and resources during execution of clinical trials.
• Provides 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.
• Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones, and goals.
• Works with teams to proactively identify and manage operational risks that arise during program and trial conduct, including escalation to Primary Operations Lead, functional management, and external vendor management to accelerate mitigation (as appropriate).
• Ensure close collaboration between Early and Late-Stage Clinical Operations Lead(s), including providing strategic and operational input during development and as the assets transition from early to late-stage development.
• Individual can anticipate, recognize and drive problem solving to rapidly address and mitigate emerging program or trial risks.
• Encourages individuals in investigating and applying clinical best practice methodologies in program(s) and clinical trials.
• Represents Clinical Operations in inspection readiness activities including coordination of trial team quality deliverables.
• Provide oversight and direction to trial team members for evaluation and implementation of patient-focused strategies for assigned trials.
• Participates in resource allocation across the department as required for portfolio delivery and non-drug project initiatives/process improvements.
• Acts as a change champion for Clinical Operations across the global organization.
• Responsible for compliance with direct reports with Astellas policies, procedures, and all associated training.
• Responsible for overseeing the development and management of department and program budgets, resources and timelines for assigned assets.