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 Northbrook, Illinois. 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 for the global execution of study start up activities for all Clinical Development Studies (Early Development & Late Stage) which may include (but not limited too): Site & Country Feasibility, Contract & Budget Negotiations, Site Payments, Regulatory Document Collection to support site initiation, ICF, site qualification & initiation visit coordination, and IRB / EC submissions.

This position will be responsible for supporting identification of and execution of interventional trial support strategies aimed at increasing productivity and quality while decreasing cycle times and cost and for the development and implementation of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development, along with functions outside of M&D, and across the early and late stage (including MA and RX+, where applicable ) clinical organizations for the relevant support functions.

This position will be a member of the Extended Clinical Operations Leadership Team (COLT) and will provide input into sub-division structure, budget and resourcing strategies, including development and implementation/oversight of processes & procedures, training, coaching and mentoring of staff.

Essential Job Responsibilities:

• Establish and lead the global study start-up department, ensuring delivery, resourcing, quality, and contractual compliance for all clinical development studies (ED & Late-Stage) across all regions

• Monitor portfolio performance against site activation timelines and metrics (e.g., as defined by corporate objectives), while adhering to budget targets

• Efficiently manage allocations of study start-up staff which includes regulatory document collection and site contracts/budgets, and frequently update resource algorithms based on portfolio needs

• Provide strong leadership and management to the study start-up team, addressing escalated / recurrent issues, finding resolutions, and continuously improving operational efficiencies of study start up activities.

• Act as the primary decision-maker for portfolio study start-up issues, collaborating with cross-functional teams to resolve problems at the study level.

• Ensure study start-up activities comply with Good Clinical Practices and internal and external regulatory standards, within expected timelines and budgets.

• Oversees and ensures consistency across and within support functions including: support for execution of high quality studies which meet regulatory requirements; adequate processes and oversight in place for outsourced work; and integration of systems and business processes to support study conduct

• May represent or participate as a member of governance committees both with vendors and external collaboration,

• Partners with cross-functional leaders on initiatives, activities and deliverables that span across Clinical Operations

Salary Range

$220K – $280K (NOTE: Final salary could be more or less, based on experience)

Qualifications:

Required

• BA/BS degree with 15+ years of experience in pharmaceutical drug development. Must be an expert in clinical trials including extensive leadership experience of global study start-up activities and study delivery.

• 5+ years of direct functional management experience

• Experience in working with teams to prepare for regulatory inspections including inspections readiness, participating in regulatory inspections and preparing responses to inspection findings.

• Strong knowledge of current regulations, trends and practices in areas of support function responsibility

• Must have excellent interpersonal, written, verbal, presentation and computer skills.

• Must have demonstrated extensive expertise in developing global clinical development strategies along with strong knowledge of ICH/GCP guidelines including multinational clinical trial guidelines

• 10 years direct people management experience

• Fluent in English (oral and written).

• Moderate (25%) travel required

Preferred:

• Experience managing international employees

• Management experience in multiple clinical operations positions

• Clinical trial management leadership

• Advanced degree (E.g. PharmD, PhD)

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

• 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 Clinical Operational Excellence

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

EOE including Disability/Protected Veterans