Otsuka Pharmaceutical Companies (U.S.)
Senior Director, Translational Medicine, CNS – Early Development
Otsuka Pharmaceutical Companies (U.S.), Princeton, New Jersey, us, 08543
Senior Director, Translational Medicine, CNS – Early Development
Otsuka Pharmaceutical Companies (U.S.)
is seeking a senior director to lead the Translational Medicine CNS Therapeutic Area. The role will report to the VP, Translational Medicine and Early Clinical Development within the Early Development Organization. This strategic scientific and clinical leader will oversee the early phase CNS portfolio, managing programs from indication selection to early clinical development (pre‑IND to first‑in‑human), and integrating across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions. The senior director will manage a small team of Translational Medicine experts and direct complex cross‑functional initiatives with enterprise impact.
Job Summary As the Translational Medicine CNS Therapeutic Area Head, the senior director will shape program strategy from indication selection through early clinical development (pre‑IND through first‑in‑human and clinical proof‑of‑concept), make go/no‑go decisions based on clinical and biomarker endpoints, and lead end‑to‑end translational strategy for Otsuka's early phase portfolio, with emphasis on psychiatry, neurodegenerative disease, and neuroinflammation. The role involves collaboration with discovery, nonclinical, clinical pharmacology, regulatory, and commercial teams, and serves as a trusted advisor to senior leadership.
Key Responsibilities Enterprise and Portfolio Leadership
Serve as subject matter expert and trusted advisor on early development strategy in the CNS space.
Lead CNS TM team on complex, business‑critical programs and shape portfolio strategy.
Drive Research‑to‑Development (R2D) strategies and stage‑gate decision‑making.
Serve as a functional cultural ambassador, fostering a high‑performance, inclusive, and learning‑oriented environment.
Translational and Clinical Development
Provide end‑to‑end translational leadership from indication selection through pre‑IND, FIH, and clinical PoC.
Collaborate with digital, diagnostics, and biomarker groups to support biomarker development.
Oversee the design and execution of FIH through PoC studies.
Ensure nonclinical, toxicology and DMPK strategies align with intended clinical plans.
Provide medical leadership for protocols, ICFs, investigator brochures, and core clinical materials; monitor safety and participate in DSMB activities.
Ensure robust collaboration with other line functions including Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development, Data & Analytics, Early Commercial, Medical Affairs, Nonclinical Toxicology, Clinical Pharmacology, CMC, and Global Pharmacovigilance.
Support and guide team through Scientific Review Board and Endorsement Board interactions.
Cross‑Functional and Governance Leadership
Provide subject matter expertise and input to multidisciplinary teams across Discovery, Bioanalysis, Biomarkers, Toxicology, Clinical Operations, Regulatory, and Biostatistics.
Anticipate and solve complex problems, balancing scientific rigor, operational feasibility, and business impact.
Present strategy, risk/mitigation, and recommendations to governance and executive committees.
External Innovation and Business Development
Lead scientific and medical due diligence for external opportunities.
Build and maintain KOL, investigator, and partner relationships; represent Otsuka at scientific, clinical, and regulatory interactions.
Drive innovation of CNS biomarkers in collaboration with biomarker and digital innovation teams.
People and Organizational Leadership
Build, lead, and develop a high‑performing director‑level Translational Medicine team.
Support the Head of Translational Medicine in departmental planning, staffing, budgeting, and expense priorities for the CNS portfolio.
Compliance, Quality, and Risk Management
Ensure adherence to GCP, ICH, and applicable regulations; drive inspection/readiness standards across programs.
Proactively identify and manage program and portfolio risks with clear mitigation and contingency plans.
Qualifications Required
MD, PhD, or MD/PhD with subspecialty training in neurology or psychiatry strongly preferred.
10–15+ years of translational and/or medical/clinical/development experience with a track record of advancing biologics and/or small molecules through IND and FIH/PoC.
Recognized thought leader with scientific contributions (publications, presentations).
Proven success leading complex, cross‑functional teams in a matrixed, global environment.
Experience in early development and Health Authority interactions (e.g., pre‑IND, IND, End‑of‑Phase 2).
Outstanding communication skills with ability to synthesize complex data and influence executive stakeholders.
Preferred
Deep expertise in CNS, particularly psychiatry, neurodegenerative disease, and neuroinflammation.
Experience implementing clinical study plans to drive decision‑making.
Experience with external collaborations, including animal model experiments, KOL interactions, and advisory boards.
Prior experience building or scaling early development operating models and ways of working.
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.
Salary Range Minimum $225,490.00 – Maximum $337,180.00, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals hired in this role in the United States.
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.
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.
Equal Opportunity Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. 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 Accommodation Request.
Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware that individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to gain access to your personal information or acquire money from you by offering fictitious employment opportunities. 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. 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 if you receive such an offer of employment. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official 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. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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is seeking a senior director to lead the Translational Medicine CNS Therapeutic Area. The role will report to the VP, Translational Medicine and Early Clinical Development within the Early Development Organization. This strategic scientific and clinical leader will oversee the early phase CNS portfolio, managing programs from indication selection to early clinical development (pre‑IND to first‑in‑human), and integrating across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions. The senior director will manage a small team of Translational Medicine experts and direct complex cross‑functional initiatives with enterprise impact.
Job Summary As the Translational Medicine CNS Therapeutic Area Head, the senior director will shape program strategy from indication selection through early clinical development (pre‑IND through first‑in‑human and clinical proof‑of‑concept), make go/no‑go decisions based on clinical and biomarker endpoints, and lead end‑to‑end translational strategy for Otsuka's early phase portfolio, with emphasis on psychiatry, neurodegenerative disease, and neuroinflammation. The role involves collaboration with discovery, nonclinical, clinical pharmacology, regulatory, and commercial teams, and serves as a trusted advisor to senior leadership.
Key Responsibilities Enterprise and Portfolio Leadership
Serve as subject matter expert and trusted advisor on early development strategy in the CNS space.
Lead CNS TM team on complex, business‑critical programs and shape portfolio strategy.
Drive Research‑to‑Development (R2D) strategies and stage‑gate decision‑making.
Serve as a functional cultural ambassador, fostering a high‑performance, inclusive, and learning‑oriented environment.
Translational and Clinical Development
Provide end‑to‑end translational leadership from indication selection through pre‑IND, FIH, and clinical PoC.
Collaborate with digital, diagnostics, and biomarker groups to support biomarker development.
Oversee the design and execution of FIH through PoC studies.
Ensure nonclinical, toxicology and DMPK strategies align with intended clinical plans.
Provide medical leadership for protocols, ICFs, investigator brochures, and core clinical materials; monitor safety and participate in DSMB activities.
Ensure robust collaboration with other line functions including Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development, Data & Analytics, Early Commercial, Medical Affairs, Nonclinical Toxicology, Clinical Pharmacology, CMC, and Global Pharmacovigilance.
Support and guide team through Scientific Review Board and Endorsement Board interactions.
Cross‑Functional and Governance Leadership
Provide subject matter expertise and input to multidisciplinary teams across Discovery, Bioanalysis, Biomarkers, Toxicology, Clinical Operations, Regulatory, and Biostatistics.
Anticipate and solve complex problems, balancing scientific rigor, operational feasibility, and business impact.
Present strategy, risk/mitigation, and recommendations to governance and executive committees.
External Innovation and Business Development
Lead scientific and medical due diligence for external opportunities.
Build and maintain KOL, investigator, and partner relationships; represent Otsuka at scientific, clinical, and regulatory interactions.
Drive innovation of CNS biomarkers in collaboration with biomarker and digital innovation teams.
People and Organizational Leadership
Build, lead, and develop a high‑performing director‑level Translational Medicine team.
Support the Head of Translational Medicine in departmental planning, staffing, budgeting, and expense priorities for the CNS portfolio.
Compliance, Quality, and Risk Management
Ensure adherence to GCP, ICH, and applicable regulations; drive inspection/readiness standards across programs.
Proactively identify and manage program and portfolio risks with clear mitigation and contingency plans.
Qualifications Required
MD, PhD, or MD/PhD with subspecialty training in neurology or psychiatry strongly preferred.
10–15+ years of translational and/or medical/clinical/development experience with a track record of advancing biologics and/or small molecules through IND and FIH/PoC.
Recognized thought leader with scientific contributions (publications, presentations).
Proven success leading complex, cross‑functional teams in a matrixed, global environment.
Experience in early development and Health Authority interactions (e.g., pre‑IND, IND, End‑of‑Phase 2).
Outstanding communication skills with ability to synthesize complex data and influence executive stakeholders.
Preferred
Deep expertise in CNS, particularly psychiatry, neurodegenerative disease, and neuroinflammation.
Experience implementing clinical study plans to drive decision‑making.
Experience with external collaborations, including animal model experiments, KOL interactions, and advisory boards.
Prior experience building or scaling early development operating models and ways of working.
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.
Salary Range Minimum $225,490.00 – Maximum $337,180.00, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals hired in this role in the United States.
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.
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.
Equal Opportunity Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. 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 Accommodation Request.
Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware that individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to gain access to your personal information or acquire money from you by offering fictitious employment opportunities. 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. 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 if you receive such an offer of employment. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official 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. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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