Senior Director Process amp Standards Excellence

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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:

The Senior Director Process & Standards Excellence is:

Accountable to proactively ensure operational excellence through the development, execution, and oversight of business change initiatives.

Responsible to provide vision, leadership and strategic direction for the development, maintenance and improvement of operational excellence and process improvement initiatives in Medical Affairs (MA), globally, including overseeing the successful delivery of cross-functional process improvement initiatives across MA.

The position is responsible for enabling stakeholders to evaluate opportunities to improve operational productivity and maximize efficiency of MA processes. The incumbent will lead the establishment of best-in-class methodologies to drive consistent implementation and use of business processes and ensure that tools are in place for optimal job performance aligned with MA operational excellence strategies and the Corporate Strategic Plan (CSP).

This position will ensure the prioritization and timely execution of process improvement projects and deliver measurable outcomes.

The incumbent brings industry insights to impact MA strategies and activities across Astellas; also drives strategy for establishment of standards for MA activities, to ensure global consistency and compliance, manage risk, and promote process efficiency through direction, oversight, and evaluation of processes owned by MA senior leaders. Works with other leaders in MA Operations, Region MA Operations, country MA Operations, Core Medical Teams (CMT), Ethics & Compliance, Legal, and Development on implementation and maintenance of MA standards.

Collaborates with Subject Matter Experts/Process Owners of MA owned processes, to ensure that Astellas develops and maintains industry leading standards & processes for all key MA activities, including, but not limited to MA Grants (e.g., Investigator Sponsored Research (ISR), Medical Education grants), MA Sponsorships, Advisory Engagement, Scientific Exchange, MA-led Symposia, Benefit Risk Team process/operations and other MA activities (i.e. Promotional and non-promotional Materials Reviews).

Essential Job Responsibilities:

Accountable for development and implementation of 1-3 year strategic Process & Standards Excellence plan/strategic roadmap.

Ensures the prioritization and timely execution of process improvement projects and deliver measurable outcomes.

Proactively identify and evaluate opportunities for process improvement and reduction of waste/inefficiencies in all Medical Affairs-related activities, focusing on compliance, simplification, and optimization.

Operationalize and execute the strategic plan for process initiatives, in collaboration with key stakeholders.

Coach, counsel, and train operational and functional leaders to apply, support, sustain and develop a Continuous Improvement culture by providing expert support, strategic oversight, and direction to all stakeholders in the establishment and maintenance of excellence in Medical Affairs process management, incorporating best practices into future iterations of processes, tools, training and/or guidance.

Oversees all planned and ongoing Medical Affairs process improvement projects and cross-functional non-MA projects that either impact Medical Affairs or are aligned to Medical Affairs strategic objectives.

Prioritize and evaluate progress, outcome, and resources, utilized for process improvement and standards excellence initiatives.

Builds and maintains strategic relationships and influence across Medical Affairs Leadership and other relevant global and regional stakeholders, to increase effectiveness in the strategic and operational needs within MA.

Provides strategic guidance on the development and implementation of M&D and non-M&D processes that impact MA, through the development and maintenance of effective strategic partnerships with both key internal stakeholders and functions (e.g., Development and Ethics & Compliance), as well as relevant external stakeholders, to effectively collaborate on the development and implementation of non-MA owned processes that impact MA.

Accountable to develop and implement a Change Management strategy for process improvements with measurable outcomes, including enhancement/adoption of best practices; collaborates with internal and external training colleagues to support effective implementation of MA procedures.

Initiate and facilitate discussions with key leaders in the business to identify gaps and areas for improvement in the business.

Apply a risk-based approach, when performing gap analyses and prioritization of activities.

Lead the strategic global assessment of continuous improvement opportunities with the business, to drive simplification, quality, and compliance.

Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations, and tools.

Represent Astellas at global forums, conferences, and professional associations on MA Standards and Excellence behalf, for in scope activities, as defined by Medical Affairs Leadership; contributes to shaping future industry best practices through committee participation.

Drive the comprehensive strategy for synthesizing industry insights and regulatory guidance for in scope activities, as defined by Medical Affairs Leadership, through cross-regional collaboration for MA activities.

Guide the integration of industry best practices and revision of global standards and guidance for in scope activities, as defined by Medical Affairs Leadership, to address changing external environment as well as internal needs.

Provide subject matter expertise and consultation to MA colleagues, regarding MA owned activities processes.

Partner with MA process owners to drive integration of MA standards, via cross-functional teams, to ensure optimal alignment within M&D and across Astellas.

Collaborate with Digital Excellence and Data Intelligence to collect, monitor and report on key performance metrics related to new or enhanced MA Processes and Standards.

Collaborates with Subject Matter Experts/Process Owners of MA owned processes, to ensure that Astellas develops and maintains industry leading standards & processes for all key MA activities, including, but not limited to MA Grants (e.g., Investigator Sponsored Research (ISR), Medical Education grants), MA Sponsorships, Advisory Engagement, Scientific Exchange, MA-led Symposia, Benefit Risk Team process/operations and other MA activities (i.e. Promotional and non-promotional Materials Reviews).

Collaborate with internal monitoring and auditing functions to drive compliance with or identify opportunities for improvement of existing procedures.

Manage the Global Medical Affairs Process & Standards Excellence function and its people. Provide performance management reviews, coaching and identification of high potential employee(s) to support their growth and development experiences that prepare them for broader responsibilities.

Accountable to meet budget objectives, projects goals, and department priorities.

Quantitative Dimensions:

Global process owner for certain global processes in Medical Affairs, as defined by MA leadership.

Responsible to provide oversight of MA owned processes, globally.

Provide subject matter expertise for up to 3-5 Medical Affairs activities under development of annual process review.

Proactive application of risk mitigation strategies that minimize corporate risk in partnership.

Impact for all 900 Medical Affairs colleagues, globally, in Astellas, by leading a team which creates/maintains global processes for all key Medical Affairs activities responsibilities.

Manage 4-6 direct reports.

Matrix management of an additional 5-10 Medical Affairs colleagues within MA regions/divisions for Process Excellence and for Standard Excellence.

Organizational Context:

Reports to Executive Director SOQT (Standards Optimization, Quality & Training)

Accountable for direct oversight and management of approximately 5 staff and matrix management of up to 10 additional MA colleagues.

Collaborate with functional Operational Excellence leads and closely partner with Process Owners for various MA led activities (e.g., Medical Information; Project Management; TA Leads) and other functions (PV, Development, etc.).

Frequent touch points with various members of the Medical Affairs Leadership team, to define or execute agreed strategic direction for procedures and risk management.

Requirements

Qualifications

Required

Advanced degree, with preference for MBA or life science PhD and MDs

Must have 12-15 years in the pharmaceutical industry, with minimum 7 years in Medical Affairs regulated/code driven environment, or in drug development under GxP.

Change Management qualification/significant experience in the successful implementation and embedding of organization wide process changes.

Strong understanding of Medical Affairs processes and procedures, to ensure cross-functional connections and operational processes are appropriately and effectively developed and communicated across the organization.

Strong leader with demonstrated ability to influence and gain alignment in cross-functional, multi-regional and matrix teams.

Minimum 10 years of people management experience, with significant exposure to leading matrix teams.

Project management experience, preferable in a highly matrixed, multicultural global setting.

Expertise in establishing cross-functional standards in alignment with regulations, codes, and industry standards, especially as they impact and influence multiple departments and levels of management.

Excellent oral and written communication and presentation skills in English, with an ability to interact at all levels of personnel.

Ability to see and communicate a vision, formulate an associated strategy, and align tactics to that strategy, for successful execution of the vision.

Strong and effective strategic thinker and problem solver with high degree of emotional intelligence, with the ability to both recognize and anticipate problems.

Possess the ability to translate solutions into viable action plans that are effectively disseminated and implemented through cooperation of stakeholders, on a global scale.

May require up to 15% international travel.

Preferred

Six Sigma, Kaizen or comparable process improvement methodology certification

Prosci or comparable change management certification

Expertise in use of enterprise-wide pharmaceutical project management software solutions, including skills in critical path analysis.

Benefits

Medical, Dental and Vision Insurance

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

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

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Location

IL, Northbrook

Category

Medical Affairs

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/