Senior Program Manager serves as a key driver on 2 or more complex development programs focused 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. May serve as supervisor for Associate Program Manager or Program Manager. Lead departmental or project initiatives as needed.
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.
Responsible for developing a working knowledge and understanding of the science, therapeutic area and commercial landscape of assigned programs.
Drives teams in the preparation of program level information and serves as a key presenter for proposals going to senior management for endorsement; ensures communication of program-level information to the wider global organization is accurate to allow strategic decision-making.
Collaborates with data science and analytics team in delivery of projects
Utilizes advanced analytics and data visualization tools to support program-level decision-making
Contributes to innovative/adaptive trial designs efforts and incorporate into program development planning as appropriate
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.
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.
Partners with Finance team in driving quarterly forecasts and mid-to-long term budget planning for defined programs; reviews, challenges and ensures endorsement of projections by Senior Management
Identify innovative solutions (e.g. automation) to business operations and collaborate with product development teams in the creation and deployment
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 (GDDP), including strategic assessment of budgets and timelines.
Familiarity with IT solutions integrated into the healthcare/pharmaceutical business.
Strong meeting facilitation skills.
Effective interpersonal communication in a remote/virtual environment; Communicates in an open, balanced and objective manner.
Diplomatically and parsimoniously identifies stakeholder groups and maintains diverse, balanced and effective teams.
Demonstrates flexibility; approaching process changes, technology and new responsibilities with and open curious mind.
Ability to focus on potential outcomes in advance of utilizing information, sourcing and processing to derive desired outcomes.
Works creatively within predefined standards.
Demonstrated knowledge and application of strategic change management.
Strong analytical skills.
Solid computer skills with MS Project, Word, Excel, PowerPoint, and Outlook.
Excellent interpersonal, communication and negotiation skills.
Bachelors degree + 7 years of PM experience in pharmaceutical or biotech industry, specifically in drug or product development
Advanced degree and global experience are a plus
Experience with Planisware is a plus
Familiarity with software development is a plus
Travel (approximate percentage): 20%
At Otsuka, we defy limitation, so that others can too. We have an unwavering belief in doing more. In transcending expectations. In going above and beyondunder any circumstancesfor patients, families, providers, and for each other. Its 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.We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology. Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho the achievement, completion, and discovery of truth; and Sozosei pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility. Learn more about Otsuka Pharmaceutical Company on its global website at http://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.