Otsuka Pharmaceutical Co.
Executive Director, Global Clinical Development Program Lead- CNS/Psychiatry
Otsuka Pharmaceutical Co., Rockville, Maryland, us, 20849
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.
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.
Minimum $249,973.00 - Maximum $388,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
Application Deadline This will be posted for a minimum of 5 business days.
Company 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.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third‑party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
Equal Opportunity 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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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.
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.
Minimum $249,973.00 - Maximum $388,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
Application Deadline This will be posted for a minimum of 5 business days.
Company 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.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third‑party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
Equal Opportunity 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.
#J-18808-Ljbffr