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Astellas Pharma Senior Vice President & Head Medical Safety Science 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 and Scope:

  • Reports to the Head of Pharmacovigilance, is a member of PV senior leadership team and participates in the creation and execution of PV mission, objectives and mid-term strategic plan and ensures the effective translation and execution into annual functional operating plans such that PV strategic goals are achieved.

  • Accountable for proactive safety surveillance of all of Astellas' healthcare products, both those in development and marketed products, including monitoring and ensuring positive benefit-risk and the optimal development, allocation and management globally (EU, JPN and US) of the medical safety science and pharmacovigilance programs and clinical plans. These functions will be conducted in collaboration with the EU and Japan QPPVs.

  • This position is responsible for providing strategic medical safety science leadership and support to the global PV management team and global Medical Safety TA leaders and Safety Science group leaders. This position will also be responsible for providing medical advice and global direction which directly influences the overall up-to-date standard of scientific excellence within PV at Astellas.

  • This position serves as medical safety scientific advisor to functions outside PV (Development, Medical Affairs, Regulatory) to ensure comprehensive medical safety accountability for products in development, marketed products, products under consideration (due diligence), and company-critical safety projects (e.g. product defense).

Essential Job Responsibilities:

Strategy, Development and Execution:

Member of PV Committee (PVC); recommends and contributes to the development of strategies, direction, decisions on organization, administration, safety and compliance matters, and management of resources. Oversees major multidisciplinary project or initiatives, and actively contribute to intra- and interdepartmental policies and procedures and plans for the implementation of new policies and procedures incident on safety strategy setting. Identifies intradepartmental areas of risk and presents potential solutions to deficiencies to upper management.

Participates in the development and implementation of mid-term PV mission, vision and strategic objectives. Develops 1-3 year strategic and operational plans for the Medical Safety Science function which align to the PV vision and is accountable for their successful execution and achievement of annual strategic objective.

Acts as the medical safety science voice and is recognized internally or externally as an expert in the areas of medical safety science and benefit-risk assessment, and routinely represents PV on safety and benefitrisk topics to external groups, including regulatory authorities and business partners. For regulatory authority meetings (including FDA Advisory Committee meetings) guides the drafting and assembly of the medical safety science components of briefing documents and determines the appropriate Astellas representation for medical safety issues.

Overseeing and managing the Medical Safety Science function:

  • Responsible for optimizing the Medical Safety Science function, determining how the strategy is deployed, and the further growth and development of the function according to the needs (internal and external).

  • Leads and is accountable for proactive safety surveillance and risk management activities from a medical safety science perspective to effect optimal safety signal detection and evaluation, risk assessment, and safety risk minimization across all products across the product lifecycle.

  • Facilitates provision of medical expertise, actively builds consensus with colleagues in other departments and upper management, and other functions with PV, including Risk Management, Epidemiology and QPPVs, and facilitates issue resolution regarding medical safety and benefit-risk issues. The position provides matrix safety team leadership in global PV. Work closely with other functions to develop, continuously update, and ensure consistency with and consensus on the use of these tools and monitoring activities.

  • Develops and oversees a Center of Excellence for product safety, guides Medical Safety Science staff to conduct proactive medical safety assessments and product defense within PV, ensures necessary training of staff members. Innovates, champions, and implements best practices, including novel approaches for these functions.

  • Provides senior-level review and, as appropriate, approval (sign off) of key safety-related Astellas documents.

The position serves as the lead point of contact for all strategic business units, chairing medical safety science teams for complex problem-solving, ensuring timely and unified communication on all safety matters, senior-level guidance on pivotal safety issues, and consistent representation of medical safety science across the entire Astellas organization.

Responsible for the medical safety science aspects of product complaint management.

Leads and provides critical guidance and trains Medical Safety Science staff and other Astellas staff to perform medical safety assessment of due diligence for new business opportunities.

People & Organization Leadership and Management

  • Responsible for the effective implementation of optimal organizational structure(s) which maximizes on the use of resources globally and reflects business needs and conditions.

  • Develops an environment to enable each member of Medical Safety Science to optimally operate in the matrix environment of PV and Astellas.

  • Displays the highest level of personal commitment to the Astellas code of Ethics. Is exemplary in ensuring "every employee deserves a great manager". Inspires while holding all appropriately accountable. Commits through co-accountability, to the growth and health of the Medical Safety Science Function, PV, and Astellas as a whole.

  • Develops and implements system of oversight which ensures technical and professional competency of all staff and ensures training specific to core operations functionalities of Medical Safety Science.

  • Manages the Medical Safety Science function and its people, through successful recruitment, performance management, development planning and retention of a high performing team. Effectively delegates responsibilities to achieve Medical Safety Science goals and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.

Quantitative Dimensions:

  • Responsible for adequate benefit-risk assessments for all Astellas drug products through close collaborations with Safety Science groups. Inadequate risk/benefit assessments may have negative impact on product success, such as delays in regulatory authority approvals and imposition of restrictive labeling, and direct and consequential threat to the viability of drug applications for regulatory approval owing to medical safety strategy quality and standards weaknesses.

  • Responsible for medical safety deliverables that may be the subject of regulatory inspections.

Organizational Context:

  • Reports to the Executive Vice President and Head Pharmacovigilance, is a member of the PVC

  • Has 5-6 direct reports including global medical safety therapeutic area leaders, and regional Medical Safety leader, Aggregate Safety Analysis Leader, and Safety Signal Management leader. Each direct report will manage 7 -- 20 team members.

  • Peers to this position include fellow global PV Function Heads and QPPVs within PV.

  • Collaborates with global leaders in Clinical Development, Medical Affairs, Regulatory Affairs, CRQA, QA, and Regional Medical Affairs.

Qualifications:

Required

  • MD/DO preferably with additional professional degree (PhD, MPH).

  • Minimum of 15 years of experience in pharmacovigilance/drug safety or combined PV/RA or clinical development experience, with at least 8 years in global medical safety

  • In-depth understanding of drug safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations, and able to drive/contribute to decisions at all levels relating to patient safety

  • Experience in planning, allocating and managing multiple projects and/or departmental budgets

  • Demonstrated global managerial responsibilities and leadership abilities, including ability to lead, manage, and mentor a global, multidisciplinary team of physicians and scientists (including line managers)

  • Sound medical knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external customers

  • Specific working knowledge and experience in related function areas, such as epidemiology, safety signal management, risk management, and periodic safety reports.

  • Excellent communication and presentation skills in English (both written and spoken)

  • Strong interpersonal skills required with a demonstrated ability to resolve conflict situations, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization, understands differences in regulations, cultures, and practices among countries, values diversity and inclusiveness.

  • Ability to deliver under pressure with limited resources.

  • Demonstrated ability to recognize, anticipate and communicate issues/problems and proactively resolve them.

Preferred

  • Ability to communicate (written, oral) in additional languages (Dutch, Japanese) preferred.

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

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Category Pharmacovigilance

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

EOE including Disability/Protected Veterans

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