Executive Director, Global Clinical Development Program Lead

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.

The specific duties assigned to the Executive Director;
Global Clinical Development Program Lead will include the following:

• 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,…