Otsuka Pharmaceutical Co., Ltd
Associate Director, Global Integrated Evidence Operations
Otsuka Pharmaceutical Co., Ltd, Princeton, New Jersey, us, 08543
The Global Integrated Evidence Operations, Associate Director role primarily focuses on leading and logistical management of integrated communication & evidence planning (ICEP) process steps, which includes managing end-to-end project plans and operational activities for developing/maintaining ICEPs in our digital planning solution.
The Global Integrated Evidence Operations, Associate Director works closely with Global Integrated Evidence Strategy lead and collaborates with cross-functional teams to manage the creation and refresh cycles of ICEPs for prioritized assets and programs, ensuring comprehensive evidence packages are available to support regulatory, launch, and post-launch strategies. In addition, the role will be critical in facilitating evidence planning and generation governance at both the leadership and team level to ensure plans are aligned with the asset vision and individual studies align with strategic objectives of ICEPs.
* Bachelor's degree in life sciences.* At least 5 years of experience in pharmaceutical and/or evidence generation and/or digital health in life sciences / technology sector.* Competence in drug development lifecycle and scientific understanding of assets.* Demonstrated solid understanding of evidence requirements in US and globally, key concepts and principles related to Ph1-4 clinical studies and non-interventional studies including an understanding of strengths and limitations of a methodological approaches and clinical trial designs.* Possess an enterprise mindset and experience establishing strong collaborative internal relationships in a matrixed organization with global and local colleagues.* Ability to gain senior leadership alignment on functional area initiatives and programs.* Excellence in strategic thinking and problem solving.* Demonstrated skills working in complex corporate environments and exercising influence without authority.* Ability to create an environment with high energy, enthusiasm, and motivation.* Ability to thrive under pressure, meet deadlines, and lead parallel projects.* Strong scientific writing skills and interpersonal written/verbal communication skills.* Capability to synthesize large amounts of data into meaningful content.* Excellent project, time management, and organizational skills.* Formal training or certification in project management methodologies (PMP, Six Sigma, Agile).* Experience in developing IEPs or managing complex processes across cross-functional stakeholders.* Experience in leading or working closely with leadership governance.* Successful execution and management of multiple projects supporting life sciences research.* Technical experience in drug development/commercialization.* Knowledge of drug development lifecycle functions such as Discovery, Clinical Trials, and Regulatory.* Experience with digital technology to support management of planning and research.**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.
You can request reasonable accommodations by contacting Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. #J-18808-Ljbffr
The Global Integrated Evidence Operations, Associate Director works closely with Global Integrated Evidence Strategy lead and collaborates with cross-functional teams to manage the creation and refresh cycles of ICEPs for prioritized assets and programs, ensuring comprehensive evidence packages are available to support regulatory, launch, and post-launch strategies. In addition, the role will be critical in facilitating evidence planning and generation governance at both the leadership and team level to ensure plans are aligned with the asset vision and individual studies align with strategic objectives of ICEPs.
* Bachelor's degree in life sciences.* At least 5 years of experience in pharmaceutical and/or evidence generation and/or digital health in life sciences / technology sector.* Competence in drug development lifecycle and scientific understanding of assets.* Demonstrated solid understanding of evidence requirements in US and globally, key concepts and principles related to Ph1-4 clinical studies and non-interventional studies including an understanding of strengths and limitations of a methodological approaches and clinical trial designs.* Possess an enterprise mindset and experience establishing strong collaborative internal relationships in a matrixed organization with global and local colleagues.* Ability to gain senior leadership alignment on functional area initiatives and programs.* Excellence in strategic thinking and problem solving.* Demonstrated skills working in complex corporate environments and exercising influence without authority.* Ability to create an environment with high energy, enthusiasm, and motivation.* Ability to thrive under pressure, meet deadlines, and lead parallel projects.* Strong scientific writing skills and interpersonal written/verbal communication skills.* Capability to synthesize large amounts of data into meaningful content.* Excellent project, time management, and organizational skills.* Formal training or certification in project management methodologies (PMP, Six Sigma, Agile).* Experience in developing IEPs or managing complex processes across cross-functional stakeholders.* Experience in leading or working closely with leadership governance.* Successful execution and management of multiple projects supporting life sciences research.* Technical experience in drug development/commercialization.* Knowledge of drug development lifecycle functions such as Discovery, Clinical Trials, and Regulatory.* Experience with digital technology to support management of planning and research.**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.
You can request reasonable accommodations by contacting Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. #J-18808-Ljbffr