Director, Risk Management and Benefit/Risk - United States
- Provide global strategic leadership and expertise on product risk management strategies for medicinal products within assigned therapeutic areas
- Contribute to the preparation and authoring of RMPs and aggregate safety documents, in conjunction with the safety management team, and respond to relevant health authority assessor queries
- As applicable, lead the development of additional risk minimization tools with scientifically balanced content grounded in risk minimization principles
- Oversee implementation of risk minimization activities by local operating companies and ensure local risk management activities are aligned with the core risk management strategy
- Provide global strategic leadership to the assigned therapeutic areas to ensure that product risk management strategies are consistent worldwide
- Accountable for risk management best practices and principles in defining a product’s risk management strategy
- Provide leadership to the assigned therapeutic area risk/benefit discussions with other functional areas
- Ensure regionally aligned principles and standard practices for risk management are consistent with global risk management policy and global benefit-risk assessment
- Maintain and author the Core RMP post-RMP for first registration and lead global communication and coordination of local implementation of the Core RMP
- Review local risk management implementation plans prepared by the local operating companies to ensure consistency with the Core RMP
- As part of the safety management team, review aggregate safety documents to ensure alignment of risks and pharmacovigilance and risk minimization measures with the Core RMP
- In conjunction with the Risk Management and Benefit/Risk team, promotes a culture of risk management and benefit/risk excellence
- Collaborate within the Risk Management and Benefit/Risk team and medical safety function, as well as engage and collaborate with partner global functions (e.g. Clinical Science, Med Affairs, Regulatory Affairs, Analytical Science)
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors degree required. Advanced degree in life sciences is preferred.
- Minimum 10 years of pharmaceutical/device industry experience with 3 – 5 years in international drug safety and risk management.
- Pharmaceutical/device experience with a high level of exposure to international drug safety and risk management.
- Experience in liaising with regulatory agencies, professional groups and/or academic centers
- Experience with developing risk minimization tools, application of a benefit-risk assessment framework, and risk minimization and REMS evaluation methods is a plus.
- Strong track record of scientific and analytical thinking
- Ability to relate well to people and to motivate and empower others
- Capacity to take initiative and work productively in a high pressure environment
- Communication with clarity and brevity
- Project management abilities and insights required to work productively in a global company and across multiple fuctions
- Strong knowledge of business area and understand the proactive interactions necessary to achieve business goals and objectives
- Capacity to manage time and priority constraints as well as manage multiple priorities simultaneously
- Attention to detail
- Computer literacy, including knowledge of safety database
- Ability to lead meetings and teleconferences, both internally in Takeda as well as externally to technical and lay groups and public meetings
- Consistent with those required for office-based work
- Some domestic and international travel may be required on an infrequent basis.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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