Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in United States or Canada. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

• This position will oversee and provide strategic direction across pre/post-POC development programs, including execution of multiple cross-therapeutic, global clinical drug development programs. Scope may also include Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
• This may include (but is not limited to) one or more of the following therapeutic areas: Oncology, Immuno-Oncology, rare disease and Biopharma, including cell and gene therapies. This position may also have responsibility for digital and combination drug-device therapeutics.
• This position will be responsible for ensuring consistent strategic input and operational insight across assets in their primary focus area of development through oversight of Clinical Operations Leads and core development plans, including the Integrated Evidence Generation (iEGP) Plan, Global Development Plan (GDP), Clinical Development Plan (CDP) and patient-focused strategies.
• This position may represent Clinical Operations in due diligence activities, providing expert input on Clinical Development Plans, operational strategies, and budget and timeline assumptions.
• This position will be a member of the extended Clinical Operations leadership team and will provide input into departmental structure, budget and resourcing strategies, development and oversight of global processes and procedures, as well as training, coaching, and mentoring of staff, both direct and indirect.

Essential Job Responsibilities:

• Accountable for assuring that clinical development teams are working within established operational standards, approved budgets and timelines.
• Works with teams to proactively identify and manage operational risks that arise during program and trial conduct across assets within their primary focus area, including escalation to functional management and external vendor management to accelerate mitigation (as appropriate).
• Interacts with key cross-functional leadership/stakeholders in strategic problem solving and contingency planning to assure progress and timely completion of trials and program deliverables according to established asset objectives, milestones and goals.
• Responsible for ensuring project teams are consistently evaluating and incorporating operational strategies with a patient focus on reducing burden and enhancing the experience of trial participants and sites.
• Considered a Subject Matter Expert and key leader in process improvements / initiatives, clinical program development strategy and clinical trial execution.
• Participates as a member of governance committees internally and with external vendors and collaboration partners.
• Ensures awareness, input and communication of high impact quality related topics for assigned assets.
• Oversees the coordination of relationships during integrations or partner collaborations for clinical work associated with an acquisition or strategic partnership.
• Ensure close collaboration between Early and Late Stage Portfolio Operations Lead(s), including providing strategic and operational input during development and as the assets transition from early to late-stage development.
• Responsible for identifying, evaluating, and advancing innovative operational strategies aimed at increasing productivity, efficiency and quality while decreasing cycle times and cost
• Responsible for the development and implementation of cross- functional and cross-regional strategies to ensure operational alignment across the global Clinical Operations organization and within the broader Medical and Development Organization.
• Responsible for compliance of direct reports with Astellas policies, procedures and all associated training.

Quantitative Dimensions:

Responsible for the oversight, management and reporting of clinical trial budgets, timelines and resources for assigned assets within a primary focus area.

Organizational Context:

This position reports into the Vice President, Clinical Operations or above, and provides functional leadership and management globally of ≥ 3 direct reports and oversight for approximately 15-20 employees globally, including international direct reports.

Qualifications:

Required

• BA/BS degree with at ≥ 15 years of direct clinical trial management experience plus exemplary performance as a Director or equivalent role with responsibility for global clinical program management
• Must have multi-trial global experience in a leadership role
• Experience in multiple therapeutic areas or disease state/indications, including life cycle management and due diligence
• 6 years of direct people management experience
• Must have demonstrated experience in leading a clinical team in the management and completion of multiple or complex clinical program(s) and participated in a regulatory submission and associated inspections.
• Significant experience in management/oversight of external providers (e.g. contract research organizations, functional service providers and range of clinical suppliers)
• Must have demonstrated extensive expertise in developing clinical development strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial guidelines (including operational, regulatory, quality, and legal aspects)
• Must have excellent interpersonal, written, verbal, presentation administrative and computer skills. Effectively present to leadership
• Fluent in English (oral and written)
• Minimal travel (~10%) required

Preferred

• Advanced degree (e.g. PharmD, PhD)
• Management experience in other clinical operations positions

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution (RRSP for Canada)
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

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Category Early Development Clinical Operations

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans