Executive Director Global Clinical Development - Nephrology
Otsuka Pharmaceutical

Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). Nephrology is considered to be a major focus within the Otsuka organization.

The Global Clinical Development function (OPDC-GCD) has responsibility for helping to define the Global R&D strategy and direct responsibility for taking all compounds from proof of concept through to Regulatory Approval, as well as lifecycle management in collaboration with other key functions.

OPDC-GCD consists of a group of physician scientists and scientists who lead clinical development activities for Otsuka's global health-care products in nephrology and tuberculosis.

Detailed Description of Duties:
Otsuka is seeking a Executive Director, Global Clinical Development-Nephrology based in our Princeton, NJ office, who will be accountable for leading the clinicians and supporting the vision and growth of the current nephrology portfolio by driving the asset development strategy, including scientific, regulatory, clinical, and post-marketing data generation (e.g., HEOR/Real-world data). This position is vital to Otsuka business strategy and overall financial success of the company. This role reports to the VP, Global Clinical Development, Nephrology.

The specific duties assigned to the Executive Director, Global Clinical Development-Nephrology will include the following:

Key Role Accountabilities:

Strategy & Execution

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  Drives the development programs with matrix team leadership across the company, scientific leadership and regulatory interaction
  
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  Drives strategy for scientific, regulatory, clinical and HEOR/Real-world data needs and identifies potential risk mitigation strategies by driving execution of development plans (including clinical, LCM clinical strategy and dosing strategy, updating core data sheet with new data, and creating and updating global regulatory submission plans)
  
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  Partners effectively with the Medical and Commercial organizations to drive asset strategy
  
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  Consults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.
  
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  Improves customer insights with meaningful scientific exchange with thought leaders
  
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  Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.
  
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  Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.
  
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  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.
  
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  Demonstrates a working knowledge of the drug development process, along 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

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  Manages clinical leads to ensure clear goals, performance standards and development plans are in place, provides feedback and coaching, and holds leaders accountable for key deliverables
  
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  Works with senior leadership to set a vision for Development Teams, and engages the matrix team on that vision.
  
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  Manages performance across the matrix team, in collaboration with the functional leaders.
  
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  Demonstrates peer-to-peer influence across R&D functional leadership
  

Stakeholder Engagement & Communication

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  Manages integration points and outbound/inbound communications with key stakeholders across all Otsuka functional and market areas to ensure alignment and minimize risk
  
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  Ensures appropriate decisions are made in a timely manner and agreed with the appropriate levels to drive milestones
  
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  Builds and manages relationships with external stakeholders (Opinion Leaders, Patient advocacy leaders, health authorities)
  
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  Interprets key clinical trial results
  
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  Interprets key regulatory milestones, communications, and engagements
  
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  Communicates key clinical trial results and regulatory milestones to appropriate governance boards
  

Qualifications

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  MD required
  
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  A minimum of 15+ years of experience in the pharmaceutical industry, with proven progression in relevant R&D roles and significant experience in related therapeutic area.
  
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  Extensive working knowledge in the drug development process, along with experience in one or more of the relevant areas (e.g. clinical, regulatory, program management, project planning and management, medical)
  
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  Experience in managing/leading high performance, cross-functional teams (Matrix) or complex organizations successfully
  
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  Understanding of regulatory policies and impact of public relations (US and Global preferred)
  
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  Demonstrated ability to successfully and effectively collaborate, cooperate and work across boundaries (e.g. R&D, disease mgt., marketing, external development) and building strong external relationships
  
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  Abreast of scientific issues as they impact business development and strategic planning
  
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  Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets
  
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  Understanding of regulatory policies and impact of public relations
  
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  Demonstrated use of communication and change management strategies/tactics to influence new ways of thinking and working
  
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  Success in effectively communicating and influencing decisions with senior management
  
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  Ability to navigate through ambiguous and changing healthcare landscape.
  
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  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).
  
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  Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
  
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  Understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
  
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  Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies.
  
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  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.
  
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  Willingness to travel 30% of time (upon normal business travel times).
  

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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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