Director Clinical Operations, Gene Therapy

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.

Qualifications

Required Qualifications: BA/BS degree with at least 12 years of executing complex global drug development programs and trials. Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives. 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. Must have experience working across multiple phases of development and in multiple therapeutic areas. Must have proven leadership skills and effective written and verbal communication skills. Fluent in English. Moderate (~25%) travel required, depending upon assigned program and phase. Preferred Qualifications: Direct people management experience Advanced degree

Location and Working Environment

This position is based in Northbrook, IL. Remote work from anywhere in the US is available. At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. This position is a global role with strong interaction with various disciplines and international stakeholders Highly matrixed environment requiring cross-regional coordination. Frequent interaction with senior leadership and governance bodies. Collaboration across EU, US, and Japan time zones.