Job Summary
Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary exists the Global Clinical Development (GCD) department.
OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products.
The Global Clinical Development Program Leader is responsible for leading the end-to-end strategy, and development and delivery of a portfolio of novel serotonergic agonists (NSA). Shaping and executing late-stage clinical development strategies for the NSA portfolio of therapeutic assets, ensuring programs progress efficiently toward registration and commercialization. This role serves as the primary and single point of contact for internal and external stakeholders, ensuring seamless integration, governance, and lifecycle management from early-stage development through submission to global health authorities. This role provides scientific, clinical, and strategic leadership across Phase II/III program design, evidence-generation plans, regulatory interactions, and cross-functional integration to support differentiated therapeutic value and patient outcomes. In addition to overseeing clinical development, the leader will play a central role in creating a unique, patient-centered go-to-market strategy tailored to the emerging psychedelic medicines landscape. This includes orchestrating health economics and outcomes research, defining care-delivery models, navigating reimbursement and market access pathways, and partnering with commercial, medical affairs, and external stakeholders to build scalable, ethically grounded treatment ecosystems.
Job Description
The specific duties assigned to the Executive Director; Global Clinical Development Program Lead will include the following:
Key Role Accountabilities:
Summary of Global Clinical Development Program Lead for the NSA Portfolio include:
- Establish & continually evolve global portfolio strategy indications/sequencing. Align with Product Development Committee (PDC) and the Early Development Team (EDT) based on internal strategy and competitive landscape
- Recommend individual asset strategies that supports a differentiated product profile including proposed go/no-go criteria (early to late phase)
- Broader portfolio evidence generation strategy
- Align COA endpoint development and validation work across individual assets
- Drive portfolio-wide stakeholder strategy through external landscape & policy shaping (GA, PASM, GMA, GRA, Corporate Comms) and identify synergies with the broader CNS portfolio
- Drive internal and external communication strategy
- Develop and continually evolve differentiated global go-to-market strategy based on unique attributes of assets within the portfolio:
- Reimbursement and coding coverage
- Broader portfolio global commercialization assessment/planning to drive asset’s global CDP
- Patient support/wrap around services
- Provide overall portfolio asset prioritization and support for discovery programs and indication selection
- Set overarching regulatory strategy and endorse individual asset strategies as needed
- Endorse proposed go/no-go criteria and support PDC for action points and EDTs for governance engagement for portfolio assets
- Endorse CDPs for discovery/early stage and late-stage programs
- Portfolio KOL engagement & patient advocacy strategy
Strategy & Execution
- 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
Leadership & Matrix Management
- Sets vision for the Product Development Team and ensures the matrix team remains aligned and engaged toward that vision
- Oversees relevant sub-teams and ensures clear goals are aligned with development team short- and long-term and performance standards are in place. Provides feedback and coaching and holds sub-team leaders accountable for key deliverables
- Manages performance across the matrix team, in collaboration with the functional leaders.
- Demonstrates peer-to-peer influence across R&D functional leadership
- Establishes trusting relationships locally and globally across the enterprise to advocate for the asset
Stakeholder Engagement & Communication
- Manages integration points and communications with key stakeholders across all Otsuka functions and market areas to ensure alignment and minimize risk
- Monitor and manage contractual obligations, performance metrics, and governance structures.
- Ensures appropriate decisions are made in a timely manner and effectively navigates relevant governance to keep stakeholders informed and aligned while driving outcomes
- Builds and manages relationships with external stakeholders (Opinion Leaders, Patient advocacy leaders, health authorities)
- Support interpretation of key clinical trial results, regulatory feedback and other relevant information and lead the integration of these new findings into the cross-functional asset strategy
Qualifications
Required
- 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..
Preferred
- 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
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
