Director, Early Clinical Development - Nephrology/Immunology (N/I)

Director, Early Clinical Development – Nephrology/Immunology

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 Nephrology/Immunology (N/I) 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 N/I indications, including but not limited to immunologic and inflammatory diseases in nephrology, rheumatology, immunology, and dermatology. 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 – N/I, 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 discovery and early phase programs and establish strategic plans and objectives.

Key Responsibilities:

• Serve as scientific and clinical expert in N/I 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 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 N/I programs.
• Support the development of team members to build translational and early clinical development expertise.
• Travel 20%

Qualifications:

Required:

• MD or MD/PhD with specialty/training in nephrology, rheumatology or immunology. Dermatologists with immunologic/inflammatory skin disease expertise may also be considered.
• 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:

• Deep expertise in N/I, particularly nephrology, rheumatology or immunology.
• 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.

Salary Range: Minimum $209,599.00 - Maximum $313,375.00, 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.