Executive Director, Global Clinical Development Program Lead

Otsuka Pharmaceutical Co., Ltd.•Rockville, MD

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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
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
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
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

Benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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