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 or Ontario, 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:

The purpose of this position is to plan, initiate and execute Biosample management activities. The position includes vendor management, training and effective interactions with study teams, process development and improvement, Biosample management system administration and sample tracking activities. Responsibilities to be performed independently with minimal guidance by supervisor.

Essential Job Responsibilities:

The Biosample Operations Manager (BOM) is responsible for all operational activities associated with the implementation and maintenance of studies in the sample management system and to act as a resource for best practices for biosample management.

The following key activities are the Sample Management responsibilities of the BOM:

Sample Management System:

• Manage and coordinate study set up in Sample Management system

• Act as liaison between study team, Sample Management vendor and Biosample vendors

• Monitor study build and rollout according to timelines.

• Ensure system training is conducted and support study team usage.

• Contribute to ongoing team forum by providing feedback on lessons learned, discuss challenges and changes etc.

• Collect and maintain completed lessons learned and evaluation documents for consolidated review

Process Development, Improvement and Maintenance:

• Support the maintenance of any associated quality documents relative to Biosample management to ensure they are kept current and accurate.

• Support the maintenance of the Biosample Operations Work Instructions and Templates.

• Participate in vendor evaluation as required (e.g., new technologies, clinical CRO selection).

• Contribute to various Medical & Development process improvement initiatives and SOP (or other quality document) development.

Training and Communication:

• Identify any training needs and participate in the development of any sustainable training materials required.

• Support the ongoing review of training materials to ensure they are current, accurately reflect the appropriate BSMO processes and are appropriately deployed to the affected departments and job functions.

• Maintain the BSMO SharePoint site.

Quantitative Dimensions:

Studies are to be planned and initiated in the sample management system with minimal guidance in accordance with agreed upon timelines and using effective vendor management strategies. Manager will be responsible for oversight and support of study teams for Sample Management activities as well as participation in ongoing development of the Astellas best practices in sample management.

Organizational Context:

Reports to Biosample Operations Lead, Early Development Clinical Operations or above.

Qualifications:

Required

• Bachelor's degree (or equivalent) with scientific or clinical background, study management experience preferred

• 2 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 1 years’ experience as clinical study manager, central laboratory project manager, data manager, or project manager.

• Working knowledge of GCP, FDA and/or EU Clinical Trials Directive guidance documents

• Experience with protocol and clinical drug development processes

• Proven project management skills and leadership ability

• Excellent interpersonal, written, and verbal communication skills and computer ability

• Fluent in English

• Moderate travel is possible

Preferred

• Experience with Biosample Tracking/Management preferred.

• Ability to integrate and apply GCP, clinical operations, and scientific knowledge in the planning, management, data review, and reporting (as applicable) of Biosample related data.

• Ability to read and understand clinical protocols and related documents, especially with regard to collection, processing, storage, and shipment of critical specimens (e.g., PK, PD, Biomarker, PGx, etc.) in accordance with the protocol, clinical operations manual, and laboratory manuals

• Problem solving, critical thinking skills (i.e., Can Identify root cause and propose/implement reasonable corrective actions in the context of region-appropriate GCP regulations and guidance, Astellas SOPs, protocol, and industry best practices; Able to apply lessons learned from prior experience to novel challenges).

• Proactive thinking skills (i.e., Can anticipate problems and take appropriate actions to avoid them).

• Highly motivated, self-directed (i.e., Ability to work independently); Follow through on commitments.

• Competent presentation skills (i.e., verbal and visual presentations are logical, organized, accurate and understandable.)

• Excellent writing skills (i.e., concise, accurate, unambiguous style without typos and grammatical errors.)

• Excellent oral communication skills (i.e., can describe experiences and issues clearly and concisely and then if necessary, provide details.)

• Highly Organized (i.e., Aware of status of tasks/milestones of assigned projects and of delegated tasks)

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

#LI-SS

Category Early Development Clinical Operations

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

EOE including Disability/Protected Veterans