Associate Director, Program Management serves as a key driver for high-priority/complex programs and provides program-level oversight to Program Managers with keen focus on strategic planning and oversight of operational execution. In this role, he/she ensures team and management alignment on program objectives, deliverables and timelines to support the organizations overall goals; works with teams and management to create the development strategy, establish objectives, and monitor team progress; and makes recommendations regarding project priorities, resource requirements, and strategic considerations to established governance committees for endorsement. As an Associate Director, he/she contributes to portfolio-level review and reporting, leads PM Departmental initiatives and manages junior PM staff.
Provides program management 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.
Drives preparation of portfolio-level summaries and program-level proposals and serves as a key presenter to senior management for endorsement; ensures communication of portfolio-level and program-level information to the wider global organization is accurate to allow strategic decision-making. Responsible for developing a working knowledge and understanding of the science, therapeutic area and commercial landscape of assigned programs.
Where applicable, functions as a development alliance liaison helping to support development alliance management activities based on program requirements.
Prepares and communicates program level information to senior management and the wider global organization to enable strategic decision-making.
Provides portfolio-level information and oversight as needed.
Serves as PM subject matter expert for organizational and cross-alliance initiatives; drive Specialty/ fit-for-purpose teams.
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. As appropriate, informs Senior management and ensures timely resolution.
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.
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.
Provides input to Finance team for finance modeling, data analytics tools and reporting; reviews quarterly forecasts, mid-to-long-term plans, key variances and potential impacts for moving forward Leads design of innovative solutions (e.g. automation) to business operations and PM's collaboration with product development teams in the creation and deployment of new solutions
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
Contributes to department-level forecasting and budget tracking
Bachelors; 10 years of Program Management experience 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
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 areas role and contribution to the development process.
Ability to develop and drive implementation of cross-functional global drug development plans, including strategic assessment of budgets and timelines.
Solid understanding of how IT solutions are integrated into the healthcare/pharmaceutical business to drive value.
Advanced meeting facilitation skills and demonstrated ability to lead brainstorming / whiteboarding discussions.
Effective interpersonal communication in a remote/virtual environment; Communicates in an open, balanced and objective manner.
Diplomatic and parsimonious identification of stakeholder groups and maintaining diverse, balanced, effective teams.
Demonstrated flexibility and approach to process changes, technology and new responsibilities with and open curious mind.
Ability to focus on potential outcomes in advance of utilizing information, sourcing /processing to derive desired outcomes.
Ability to work creatively within predefined standards.
Demonstrated knowledge and application of strategic change management
Financial management knowledge
Strong analytical skills.
Solid computer skills with MS Project, Word, Excel, PowerPoint, and Outlook.
Excellent interpersonal, communication and negotiation skills.
Experience with Planisware is a plus
Experience with Software Development Lifecycle (SDLC) is a plus
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide. Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a big venture company at heart, applying creativity in everything it does. Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion ( 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en . Learn more about Otsuka in the U.S. at www.otsuka-us.com .
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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At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.