Director, Early Clinical Development - CNS

Otsuka Pharmaceutical Co., Ltd; United States; Sur place; USD 186 000 - 279 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits

401(k) match

Paid time off

Résumé du poste

Otsuka Pharmaceutical Co., Ltd is seeking a Director of Early Clinical Development (ECD) focusing on CNS programs. You will shape strategy from target ID through IND/PoC, directing translational studies, biomarker strategies, and regulatory readiness while aligning with discovery, nonclinical, and commercial teams.

You will lead cross-functional teams, collaborate with external experts, and ensure safety monitoring and governance across assets in the CNS space.

Qualifications

• MD/PhD with subspecialty training in Clinical psychology/neuropsychology.
• 5+ years translational medicine or early clinical development experience with biologics or small molecules.
• Ability to coordinate cross-functional teams in a global setting and influence stakeholders.
• Outstanding communication skills with the ability to synthesize complex data.

Responsabilités

• Serve as CNS translational medicine and early clinical development expert on strategy and development teams.
• Drive R2D strategies and stage-gate decisions based on mechanistic rationale and endpoints.
• Interact with internal/external groups to evaluate new compounds and targets.
• Collaborate with external experts and KOLs to inform PoC strategy.
• Support regulatory interactions (pre-IND/IND) and ensure alignment with regulatory requirements.
• Lead development efforts from target ID through IND and PoC, including protocols and safety oversight.

Connaissances

MD/PhD or equivalent

Translational medicine

Early clinical development

Cross-functional leadership

IND/FIH/PoC experience

Biomarkers

Regulatory collaboration

Communication skills

Decision making under uncertainty

Formation

MD/PhD or PhD with clinical psychology/neuropsychology subspecialty

Description du poste

The Director will lead activities related to Early Clinical Development (ECD) essential to the growth of Otsuka's discovery and early phase pipeline within OPDC's Early Development Organization (EDO). Reporting to the ECD CNS Therapeutic Area Head, this Director is a strategic scientific and clinical leader accountable for the end-to-end early clinical development 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. The Director, ECD - CNS, in alignment with the ECD therapeutic area head and functional head VP, collaborates with EDO senior leaders to identify, introduce, and implement translational tools or studies for early phase programs and establish strategic plans and objectives.

Key Responsibilities:

• Serve as scientific and clinical expert in CNS translational medicine and early clinical development, contributing to strategic program decisions; serve as ECD lead on development teams for multiple 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. Prepare and present decision-quality data packages for internal governance reviews to support stage-gate decisions.
• Interact with internal and external groups to evaluate new compounds, molecular and biological targets as well as new formulation technologies.
• Partner with internal and external research organizations to expand and facilitate development of early phase and discovery phase compounds. Engage with external experts and key opinion leaders to inform translational and Proof of Concept (PoC) strategy and maintain scientific leadership.
• Represent ECD in cross functional as well as internal/external collaborations (BD, etc.) on activities related to early phase target and asset identification. Support regulatory interactions (e.g., pre-IND, IND submissions) and ensure translational strategies align with regulatory requirements.
• Lead scientific and clinical development efforts for assigned programs from target identification through IND and proof-of-concept. Provide medical leadership for early-phase clinical protocols, informed consent forms, and investigator brochures; monitor safety and contribute to DSMB or safety review activities as needed.
• Support or lead or public-private partnerships operating in pre-competitive settings to advance internal clinical development capabilities.
• Interact with other disciplines within the EDO to promote, initiate and elevate cross-functional early development activities. Collaborate with biomarker and digital innovation teams to develop and implement biomarker-driven approaches for CNS programs.
• Support the development of team members to build translational and early clinical development expertise

Travel 20%

Qualifications:

Required

• MD, MD/PhD, or PhD with subspecialty training in Clinical psychology/neuropsychology
• 5+ years of translational medicine and/or early clinical development experience with a track record of advancing biologics and/or small molecules through IND and FIH/PoC.
• Expert understanding of industry best practices and adjacent functional areas.
• Demonstrated ability to coordinate and guide cross-functional teams in matrixed, global setting, with solid strategic thinking and the ability to make informed decisions amid uncertainty.
• Outstanding communication skills with the ability to synthesize complex data and influence executive stakeholders.

Preferred

• MD with specialty training in psychiatry and/or neurology.

• Deep expertise in CNS, particularly psychiatry, neurodegenerative disease, and/or neuroinflammation.
• Experience implementing clinical study plans to drive decision-making.
• Experience with external collaborations.

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.

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, and employees.

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 $186,489.00 - Maximum $278,875.00, 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://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.

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 [e-mail].

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.