The Director, R&D Asset Manager serves as a key driver for high-priority complex programs and provides program-level oversight to Asset Managers with keen focus on strategic planning and oversight of operational execution.
Key Job Responsibilities:
- Provide oversight of program managers for complex development programs and special projects.
- Manages established cross-functional teams and relevant functional areas to lead the development of quality Global Development & Commercialization Plans (GDCPs) which integrate the development strategy and project plan (inclusive of timelines, milestones, interdependencies, issues, risks and actions).
- Responsible for ensuring smooth transitions between stage gates of drug development from initiating IND through product launch and full life cycle management. Facilitates the review of development project proposals with Senior Management, makes recommendations for action and ensures appropriate follow-through to achieve approved program/project objectives.
- Responsible for developing a working knowledge and understanding of the science, therapeutic area and commercial landscape of assigned programs.
- Presents portfolio-level information to senior management for review and strategic decision-making; assesses risks and issues and recommends mitigation and resolution strategies; ensures portfolio-level information is accurate and available to allow strategic and timely decision-making across the wider global organization.
- Serve as PM subject matter expert for organizational and cross-alliance initiatives; drive Specialty/ fit-for-purpose teams.
- Supports commercial launch preparation activities.
- Identifies new impactful opportunities and leads PM's collaboration with data science and analytics team in delivery of projects to address business needs.
- Contributes to the design and drive utilization of advanced analytics and data visualization tools to deliver insights to key stakeholders for portfolio-level and program-level decision making; Present summary information to audience of various forums utilizing tools/dashboards.
- Drives teams to increase flexibility, efficiency and speed of development programs through innovative/adaptive trial design efforts and streamlined execution.
- Contribute to due diligence activities to support business development.
- Where applicable, functions as a development alliance liaison helping to support development alliance management activities.
- Manages and facilitates Executive governance committees.
- Supports the project teams toward implementation of the strategic and operational plans and tracks progress to goals.
- Manages and tracks program progress as assigned on a continual basis, identifying and tracking both cross-project and cross-functional risks and issues related to scope, timelines and budget.
- Identifies innovative approaches to business operations (automation)
- Manages project information for assigned projects and is responsible for developing and maintaining good relationships with other functions fostering positive interactions and ultimately support achieving desired project outcomes.
- Provides input to Finance team for finance modeling, data analytics tools and reporting; at the Portfolio-level, reviews quarterly forecasts, mid-to-long-term plans, key variances and potential impacts for moving forward; identifies opportunities to integrate financial data into broader portfolio-level reporting; drives alignment between program development planning and financial planning.
- Drives design of innovative solutions (e.g. automation) to business operations and oversee PM's collaboration with product development teams in the creation and deployment.
- Participates in CRO and ancillary vendor selection and oversight.
- Responsible for supporting departmental and corporate initiatives to drive process improvements.
- Responsible for maintenance of the project actions, decisions and risks for project team interactions.
- Contributes to department goal-setting and serves as Lead for departmental initiatives
- Provides managerial oversight of day-to-day clinical program management deliverables.
- Serves as supervisor for PM staff and provides development and coaching for program managers
- Manages PM resources and program assignments; attends to HR-related items
- Contributes to department-level forecasting and budget tracking
- Understanding of the clinical, regulatory, and commercial requirements for early and late-stage drug development
- Knowledge of clinical operations and the regulatory process.
- Knowledge of global drug development, registration, and market launch requirements.
- Thorough understanding of each functional area's role and contribution to the development process.
- Ability to develop and drive implementation of cross-functional global drug development plans (GDDP), including strategic assessment of budgets and timelines.
- Demonstrated contribution to the development of IT solutions in the healthcare/pharmaceutical business resulting in increased value.
- Advanced meeting facilitation skills, specifically with Executive and Sr. Mgmt, and demonstrated ability to lead brainstorming / whiteboarding discussions.
- Demonstrated flexibility; approaching process changes, technology and new responsibilities with and open curious mind.
- Diplomatically and parsimoniously identifies stakeholder groups and maintains diverse, balanced and effective teams.
- Ability to drive teams to focus on potential outcomes in advance of utilizing information, sourcing /processing to derive desired outcomes.
- Ability to foster an environment where creativity within predefined standards is acknowledged and encouraged.
- Served as a change agent on organizational, departmental and team initiatives. Leads team in the development and execution of strategic change management plans.
- Financial management knowledge
- Strong meeting facilitation skills.
- Solid computer skills with MS Project, Word, Excel, PowerPoint, and Outlook.
- Effective interpersonal communication in a remote/virtual environment; communicates in an open, balanced and objective manner. Bachelors; 12 years of PM in pharmaceutical or biotech, specifically drug or product development; people management experience.
- Advanced degree, Agile Methodology and global drug development, alliance management and/or business development is a plus.
- Experience with Planisware is a plus.
- Experience with Software Development Lifecycle (SDLC) is a plus.
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.Statement Regarding Job Recruiting Fraud Scams
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