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

Job Listing ID:

4491177

Job Title:

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

Application Deadline:

Open Until Filled

Job Location:

Salem

Date Posted:

05/13/2026

Hours Worked Per Week:

Not Provided Shift:

Not Provided Duration of Job:

Either Full or Part Time, more than 6 months You may contact this employer directly. (Obtain the contact information to print or add to your jobs.)

Job Summary:

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 s...

Job Classification:

Medical Scientists, Except Epidemiologists Access our statewide or regional occupation report for more information about wages, employment outlooks, skills, training programs, related occupations, and more. Compensation

Salary:

Not Provided Job Requirements

Experience Required:

 See Job Summary

Education Required:

None

Minimum Age:

N/A Gender:

N/A