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Astellas Pharma Senior Manager/Associate Director Clinical Operations in Northbrook, Illinois

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 & Scope:

The Associate Director, Clinical Operations within Medical Operations has responsibility for strategic operational planning, oversight and/or execution of Medical Affairs data generation activities, including Astellas Sponsored Research (interventional, non-interventional, and HEOR studies) and Collaborative Research (CR). The Associate Director is responsible for working closely with key stakeholders across the region. This individual serves as an integral member of the Clinical Operations Team and provides strategic guidance on activities associated with data generation including internal/external collaborations. The Associate Director may be a people manager within Clinical Operations as applicable.

Essential Job Responsibilities:

Tactic Management

  • Direct key initiatives and tactics to support Medical Operations including budgeting and planning, synopsis/protocol coordination, vendor selection and oversight, alignment of timelines and plans, etc.

  • Support assessment of resource needs related to data generation activities and CMP deliverables

Operational Excellence

  • Create and monitor reports on key performance metrics and status of data generation activities aligned with Core Medical Plans

  • Responsible for support of data generation processes and ensuring compliance with all applicable legal and regulatory, quality and compliance guidelines and creation/update of same as necessary

  • Apply best practices of GCP across multiple study types including HEOR led prospective and retrospectives studies

  • Lead process improvement projects for Medical Operations as needed

Collaboration

  • Engage with internal and external stakeholders concerning planning, oversight, execution and reporting of data generation activities, including but not limited to systems such as IMPACT and HELIX

  • Coordinate and work closely with all stakeholders involved with data generation activities including Therapeutic Area (TA), Medical Affairs Groups (Operational Excellence, Regional Medical/Clinical Operations), Advanced Informatics and Analytics (AIA), Regulatory, Legal, Ethics & Compliance, Procurement, Pharmacovigilance,

  • Create and facilitate study quality and compliance check process for MA data generation activities

  • Provide subject matter expertise in review of Process Improvement and Quality Documents relating to Medical Operations activities

  • Create, conduct and/or recommend training in order to maintain and/or enhance MA knowledge of appropriate data generation processes

Quantitative Dimensions:

The Associate Director responsibilities span the entire product portfolio of data generation activities within MA. The Associate Director is part of a high performing Clinical Operations team with indirect budget responsibilities of up to $15M annually, including 15-25 data generation projects annually. This includes creation, identification and tracking of budgets and metrics. The Associate Director may have direct reports or manage contract personnel., including setting performance objectives and development plans, and conducting annual performance The Associate Director is accountable for MA deliverables and will demonstrate solid leadership with both internal and external leaders. The results produced by the Associate Director must be operationally sound and in compliance with applicable regulations.

Organizational Context:

The Associate Director reports to the Sr. Director, Medical Operations or above and will work within multiple cross-collaborative project teams and have matrix responsibilities. The Associate Director will collaborate with the following colleagues:

  • MA: Medical Directors/RMT leads/CMT members, Health Economics & Outcomes Research Managers/Directors, Training, Project Management, Medical Science Liaisons, Operational Excellence, Regional Medical/Clinical Operations

  • M&D: Pharmacovigilance, Regulatory, Project Management

  • Advanced Informatics and Analytics (AIA)

  • Other: Procurement, Finance, Legal, Ethics & Compliance

  • External: Key External Experts, Astellas partners, and medical organizations

Qualifications: Required

  • Minimum of a bachelor's degree in health-related sciences

  • Minimum of 10 years of experience with a BA or BS OR minimum of 7 years of experience with a MS OR minimum of 5 years of experience with a MD, PhD, PharmD in the pharmaceutical industry or related fields

  • Proven Project Management skills

  • Demonstrated ability to manage multiple projects and competing priorities

  • Demonstrated high level of competence with MS Office applications and SharePoint,

  • Clinical study management experience

  • Demonstrated knowledge and understanding of research protocols and study design

  • Strong interpersonal skills (verbal and written) with a high degree of analytical ability, communication skills, conflict-resolution skills, organization and planning skills and budget/accounting

  • Ability to maintain data and confidentiality

  • Demonstrated personnel management skills

Qualifications: Preferred

  • Advanced degree in health-related clinical sciences

  • Solid expertise in developing synopsis and protocols

  • Experience with investigator sponsored research

  • Experience in real-world data analytics

  • Direct experience in working with key external experts

BENEFITS

  • Medical, Dental and Vision insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown

  • 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

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.

*LI-CH1

Category Medical Affairs

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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