Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary exists the Global Clinical Development (GCD) department.
OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka's global health-care products. Our team is collaborative, innovative with a mantra of "acting as though the company was our own."
Our responsibilities range from due-diligence evaluations, where we stress-test others' development plans, to development and implementation of our own global development & commercialization plans which translates basic research and preclinical pharmacology & toxicology into a streamlined plan for first in man, proof of mechanism, registrational and post-approval trials. Its goal is to efficiently evaluate the product's potential and probability of success, supporting meaningful innovations to improve or expand the value of the initial product for our global customers.
Otsuka is seeking a Senior or Executive Director, Global Clinical Development Team Leader based in our Princeton, NJ office (remote flexibility in the US), who will be accountable for the vision and growth of Tuberculosis products, by driving asset development strategy and global health and business partnerships. The Development Team Leader reports to the VP, Global Clinical Development-Nephrology.
Key Role Accountabilities:
Strategy & Execution
Creates and delivers asset/brand vision and strategy through all lifecycle development activities, including registrational studies and post-marketing studies
Partners effectively with the Medical, Public Affairs, and Global Health colleagues and organizations to drive asset strategy
Oversees and adheres to the OPDC processes for the selected asset and the achievement of key milestones
Drives strategy for scientific, regulatory, clinical, and real-world data needs and identifies potential risk mitigation strategies by driving execution of development plans
Improves customer insights with meaningful scientific exchange with global thought leaders
Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical, public affairs, other research project team members, and to external parties and regulatory agencies.
Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear, and convincing argumentation in all such written and verbal communications.
Demonstrates a working knowledge of the drug development process, preferentially with experience in one or more of the relevant areas (e.g., clinical, regulatory, program management, project planning and management, clinical pharmacology, statistics).
Leadership & Matrix Management
Works with senior leadership to set a vision for tuberculosis development and engages the matrix team on that vision.
Manages performance across the matrix team, in collaboration with the functional leaders.
Oversees relevant sub-teams and ensures clear goals and performance standards are in place, provides feedback and coaching, and holds sub-team leaders accountable for key deliverables
Demonstrates peer-to-peer influence across R&D functional leadership
Stakeholder Engagement & Communication
Manages integration points and outbound/inbound communications with key stakeholders across all Otsuka functional and global health areas to ensure alignment and minimize risk
Ensures appropriate decisions are made in a timely manner and agreed with the appropriate levels to drive milestones
Builds and manages relationships with external stakeholders (Opinion Leaders, Patient advocacy leaders, health authorities)
Interprets key clinical trial results
Interprets key regulatory milestones, communications, and engagements
Communicates key clinical trial results and regulatory milestones to appropriate governance boards
5 years of experience in the pharmaceutical industry or academic research is preferred, with proven progression in relevant roles
Medical, clinical and/or public health experience within the therapeutic area of infectious disease and/or with tuberculosis.
Working knowledge of the drug development process, along with preferred experience in one or more of the relevant areas (e.g. clinical, regulatory, program management, project planning, management, medical, and global health)
Experience in managing/leading high performance, cross-functional teams (Matrix) or complex organizations successfully
Understanding of regulatory policies and impact of public relations (US and Global preferred)
Understanding of political dynamics within the tuberculosis and/or global health community
Demonstrated ability to successfully and effectively collaborate, cooperate and work across boundaries and building strong external relationships
Abreast of scientific and global health issues as they impact business development and strategic planning
Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets
Demonstrated use of communication and change management strategies/tactics to influence new ways of thinking and working
Success in effectively communicating and influencing decisions with senior management
Ability to navigate through ambiguous and changing healthcare landscape
An ability to communicate effectively in meetings and via written and oral presentations is essential. This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
Understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
Dedication to assigned, developed projects and project goals. This includes an appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting.
Willingness to travel 30% of time, over weekends and ability to travel internationally.
Disclaimer: 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.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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