What are the responsibilities and job description for the Senior Director, Translational Medicine, CNS – Early Development position at Otsuka Pharmaceutical Companies (U.S.)?
Job Summary
The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early Clinical Development within OPDC’s Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS Translational Medicine Experts reporting to her/him on the early development CNS portfolio and Early Development Teams. This Senior Director is a strategic scientific and clinical leader accountable for the end-to-end translational strategy and execution for Otsuka's early phase portfolio, with emphasis on CNS, particularly psychiatry, neurodegenerative disease, and neuroinflammation. The role shapes program strategy from indication selection through early clinical development (pre-IND through first-in-human and clinical proof of concept), and go/go no decisions based on clinical and/or biomarker driven endpoints ensuring seamless integration across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions. As an industry-leading expert and trusted advisor to senior leadership, this leader directs complex, cross-functional initiatives with enterprise impact, and helps define the operating model and culture of the EDO.
Key Responsibilities
Enterprise and Portfolio Leadership
Required
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 $225,490.00 - Maximum $337,180.00, 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.
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 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.
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.
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.
The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early Clinical Development within OPDC’s Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS Translational Medicine Experts reporting to her/him on the early development CNS portfolio and Early Development Teams. This Senior Director is a strategic scientific and clinical leader accountable for the end-to-end translational strategy and execution for Otsuka's early phase portfolio, with emphasis on CNS, particularly psychiatry, neurodegenerative disease, and neuroinflammation. The role shapes program strategy from indication selection through early clinical development (pre-IND through first-in-human and clinical proof of concept), and go/go no decisions based on clinical and/or biomarker driven endpoints ensuring seamless integration across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions. As an industry-leading expert and trusted advisor to senior leadership, this leader directs complex, cross-functional initiatives with enterprise impact, and helps define the operating model and culture of the EDO.
Key Responsibilities
Enterprise and Portfolio Leadership
- Serve as subject matter expert and thought leader in areas of strategic importance to Otsuka; act as a trusted advisor to senior leadership on early development strategy in the CNS space.
- Lead CNS TM team on complex, business-critical programs with enterprise impact; shape portfolio strategy and influence resource allocation for Otsuka's early phase assets.
- Drive Research-to-Development (R2D) strategies and stage-gate decision-making, including indication prioritization and go/no-go based on mechanistic rationale, benefit-risk, and clinical unmet need as well as on clinical and/or biomarker driven endpoints.
- Serve as a functional cultural ambassador, modeling EDO Ways of Working and fostering a high-performance, inclusive, and learning-oriented environment.
- Provide end-to-end translational leadership from indication selection through pre-IND, FIH, and clinical PoC, integrating pharmacokinetics, pharmacodynamics, safety, and biomarker strategies.
- Collaborate with digital, diagnostics and biomarker groups to support the development of biomarkers throughout the life cycle of Otsuka's compounds.
- Oversee the design and execution of FIH through PoC studies; ensure robust translational hypotheses, dose selection, and decision-quality data packages.
- Ensure nonclinical, toxicology and DMPK strategies are aligned with intended clinical development plans.
- Provide medical leadership for protocols, ICFs, investigator brochures, and core clinical materials; monitor safety and participate in safety review/DSMB activities in EDO as needed.
- Ensure CNS TM team robustly represents line function via collaboration with other line functions including but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development (late phase), Data & Analytics, Early Commercial, Medical Affairs, Nonclinical Toxicology, Clinical Pharmacology, CMC, and Global Pharmacovigilance.
- Support and guide team through all Scientific Review Board and Endorsement Board interactions, as part of the EDO.
- Provide subject matter expertise and input to multidisciplinary teams across Discovery, Bioanalysis, Biomarkers, Toxicology, Clinical Operations, Regulatory, and Biostatistics; drive alignment and accountability to milestones.
- Anticipate and solve multi-dimensional complex problems, balancing scientific rigor, operational feasibility, and business impact.
- Present strategy, risk/mitigation, and recommendations to governance and executive committees; influence enterprise decision-making.
- Lead scientific and medical due diligence for external opportunities (academic collaborations, in-licensing candidates, platforms); benchmark against competitive landscape and standards of care.
- Build and maintain strong KOL, investigator, and partner relationships; represent Otsuka and OPDC at scientific, clinical, and regulatory interactions.
- Drive innovation of CNS biomarkers in collaboration with biomarker and digital innovations teams and serve as subject matter expert related to relevance of CNS biomarkers for go/no-go decisions.
- Build, lead, and develop a high-performing director-level Translational Medicine team (MDs, PhDs, and MD, PhDs, including Directors/Senior Directors); drive succession planning and talent development.
- Support the Head of Translational Medicine in departmental planning, including staffing, budgeting, and expense priorities pertaining to the CNS portfolio.
- 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.
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); expert understanding of industry best practices and adjacent functional areas.
- Proven success leading complex, cross-functional teams in a matrixed, global environment; exceptional strategic thinking and decision-making under uncertainty.
- Demonstrated experience in early development and Health Authority interactions (e.g., pre-IND, IND, End-of-Phase 2) and high-quality health authority engagement.
- Outstanding communication skills with the ability to synthesize complex data and influence executive stakeholders.
- Deep expertise in CNS, particularly psychiatry, neurodegenerative disease, and neuroinflammation.
- Experience implementing clinical study plans to drive decision-making.
- Experience with external collaborations, including collaborative animal model experiments, key opinion leader interactions and advisory boards.
- Prior experience building or scaling early development operating models and ways of working.
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 $225,490.00 - Maximum $337,180.00, 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.
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 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.
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.
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.
