Executive Director, Global Clinical Development Program Lead

* Serve as the primary point of contact for key partners, ensuring collaborative and productive relationships.* Drives the asset’s initial indication development strategy, including scientific, regulatory, and clinical access.* Drives asset/brand vision and strategy through all lifecycle development activities, including registrational studies, as well as post-marketing studies* Shapes products for competitive profile that achieves pricing, reimbursement, access and penetration by developing target product profile, developing initial indication label in-line with target profile, and creating economic value dossier* Oversees and adheres to the governance processes for the selected asset and drives the achievement of key milestones* Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other team members, and to external regulatory agencies.* Constantly seeks innovative ways to grow the value of the asset throughout the product lifecycle by leveraging the team’s experience and skillset.* Co-leads regulatory filing activities through NDA. Provides strategic direction to ensure concise, clear and convincing argumentation in all written and verbal communications.* Recommends Business Development activities necessary for optimization of the portfolio value i.e., provide development perspective during due diligence or recommend opportunities that can help further support the specific portfolio group of assets* A minimum of 10 years of experience in the pharmaceutical industry, extensive working knowledge in the drug development process with proven progression in relevant R&D roles and significant experience in related therapeutic areas as well as pediatric drug development.* 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)* 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* Abreast of scientific 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* Understanding of regulatory policies and impact of public relations* 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* 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.* Willingness to travel 35% of time, over weekends and ability to travel internationally..* MD / PhD / PharmD / secondary scientific degree preferred or commensurate experience* Medical, clinical and/or public health experience within the therapeutic area of psychiatry or neurology**Competencies**

**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.

**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

**Respectful Collaboration -** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

**Empowered Development -** Play an active role in professional development as a business imperative.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.If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.

You can request reasonable accommodations by contacting Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s 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. #J-18808-Ljbffr