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Astellas Pharma Executive Director Medical Safety Science in Northbrook, Illinois

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing an Executive Director Medical Safety Science opportunity in Northbrook, IL.

Position & Scope:

Reports to the Head of Medical Safety in Pharmacovigilance. Is a head of multiple Therapeutic Areas (TAs) and of the Medical Safety Leadership Team. Takes a critical role in the creation and execution of multiple TA strategic plans. Leads multiple TA teams to carry out all required activities and tasks to ensure that product safety are monitored closely, assessed properly, communicated timely, and managed effectively.

Responsible for (1) providing medical safety leadership and direction to multiple A teams, (2) designing and implementing medical safety strategies for drug products within the multiple global TAs, (3) authoring, reviewing, and approving medical-scientific reports, safety analyses, and safety evaluations, and (4) ensuring cross-functional collaborations with other PV functions (such as PV Process, Safety Science) and with other M&D functions including Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance.

Represents Medical Safety in cross-functional task forces within PV, or within M&D, or with external stakeholders for strategic initiatives relevant to medical safety.

Essential Job Responsibilities:

Responsible and accountable for the assigned multiple TA teams who are conducting medical-scientific monitoring and assessment of the safety profile of specific Astellas products assigned to the TAs.

Leads and manages all staff members and contractors in the assigned multiple TA areas. Continue to develop talents and teams. Ensure all members are up to date with medical safety knowledge, regulatory requirements, company policies, and PV standard procedures.

Timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator's Brochure and local product labeling. This also includes responsibility for effective and regular communication with the Head of Medical Safety and with the applicable QPPV.

Provides guidance and support to member who are responsible and accountable:

(1) for the design of safety surveillance strategies, management of safety signals for Astellas drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with PV colleagues in Safety Science;

(2) for the risk management Astellas drug products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders, working closely with Safety Science.

(3) for timely and high quality contribution to periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions.

(4) for the ongoing monitoring and assessment of the safety profile of assigned Astellas developmental and marketed products as a member of study teams and for representing PV in the design, conduct, analysis and reporting of Phase 1 -- Phase 3 clinical trials and PostAuthorization Studies.

Strategy Development and Execution

Plays a key role in the identification, development, implementation, and communication of process improvements tools, systems and procedures within Medical Safety to assure efficiency and consistency in safety surveillance in the assigned multiple TAs, and by collaboration with other functional areas within PV. Leads/participates in specific working groups and task forces to accomplish these objectives.

Builds key relationships with external stakeholders within Astellas (particularly, Clinical Development, Medical Affairs, Regulatory Affairs, and Quality Assurance) to improve collaboration and provide pharmacovigilance expertise to identify issues, develop and implement solutions within cross-functional working groups and task forces either as a participant or as a leader.

Plays a key role in PV inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to the respective multiple TAs, and, as appropriate, across Medical Safety groups, ensuring feasibility and global alignment in collaboration with the Medical Safety Leadership Team.

People & Organization Management

Leads, manages, and continuously develops multiple TA teams of physicians and PV scientists through successful recruitment, mentoring of members, development of staff, developing and monitoring business objectives (on A level), resource planning and allocation and budgeting in close collaboration with the Head of Medical Safety.

Ensures an appropriate level of safety training for all team members both within the TA teams. Ensures group and individual goals are achieved. Promote appropriate people growth in technical skills, communication skills and other identified areas for learning and updating. With the support of the Head of Medical Safety, leads development of quality metrics, identifying training needs, and developing and delivering training.

Demonstrates the highest level of personal commitment to the Astellas code of Ethics and the seven key Astellas competencies. Inspires team members while holding accountable. Commits through co-accountability, to the growth and health of the teams, the Medical Safety, and PV as a whole.

Quantitative Dimensions:

Responsible and accountable for adequate benefit-risk assessments for assigned Astellas drug products within the TA. 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 and accountable for strategic initiative outcomes within PV and with external stakeholders. Successful implementation of these initiatives is expected to optimize resource utilization and reduce costs (in particular reducing the need for external contractors) through utilization of more efficient processes.

Organizational Context:

  • Reports to the Head of Medical Safety in PV.
  • Peers in this position include fellow Executive (Medical) Directors in Medical Safety, fellow Executive Directors in other PV function areas such as PV Process, Epidemiology/SignalManagement, and Risk-Management/Benefit-Risk-Assessment.
  • Collaborates with other Medical Safety TA leaders, other PV function group leaders, and other functions such as Clinical Development, Medical Affairs, Regulatory Affairs, and Quality Assurance.

Qualifications

Required

  • D. or D.O. (board certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred); or other advanced professional degree such as PharmD or PhD (pharmaceutical industry experience in a relevant therapeutic area preferred).

For Executive Medical Director title: Holds an appropriate medical degree

(otherwise title is Executive Director)

  • Minimum of at least 10 years of experience in the pharmaceutical industry and/or a relevant health science setting (such as academia). Direct exposure to pharmacovigilance functions, additional regulatory and/or clinical development experience is a plus.
  • In-depth understanding of drug safety regulations for both marketed and investigational products, and excellent knowledge of regional and global health authority requirements, including ICH, and other applicable requirements/guidance, able to influence decisions relating to patient safety and assessment of benefit-risk.
  • In-depth understanding of pharmacovigilance processes relevant to Medical Safety.
  • Demonstrated strong leadership, people management experiences, and mentoring capabilities, including the ability to work within a complex matrix environment and lead multifunctional teams.
  • Experience in planning, allocating and managing multiple projects.
  • Sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to communicate with both internal and external stakeholders.
  • Specific working knowledge and experience in medical safety functions, including safety risk, signal management and periodic reports; prior experience in these functions acquired in other pharmaceutical companies desired.
  • Excellent communication and presentation skills in English (both written and spoken).
  • Strong interpersonal skills required with a demonstrated ability to handle conflict situations, think strategically, generate solutions to problems, build consensus across teams and functions, and understand regional differences in both regulations and cultures.
  • Ability to deliver under pressure with limited but reasonable resources.
  • Ability to travel to meet the needs of the role.

Preferred

  • Can be located in Northbrook, US, Leiden, Netherlands
  • In-depth understanding including industry-wide best practices for pharmacovigilance functions relevant to Medical Safety.

#LI-NB

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Pharmacovigilance

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