Job SummaryThe Director, Nonclinical DMPK is responsible for strategic, technical and scientific matters related to the design, execution and evaluation of Nonclinical DMPK programs for small molecules. The role provides strategic leadership for Nonclinical DMPK activities across multiple discovery and development programs and serves as a recognized scientific expert within the organization. The position influences portfolio decisions, establishes scientific standards and best practices, and provides strategic DMPK guidance to cross-functional teams and senior leadership to support program advancement and regulatory objectives.. This includes the preparation of regulatory documents such as INDs, NDAs, aggregate reports, fast track designation, 8-FA, ICFs, and briefing books.
Job Description- Serve as the DMPK functional expert on cross-functional discovery and development teams and provide strategic nonclinical safety recommendations to support program progression and development decision-making
- Communicate DMPK findings and risk assessments to project teams and senior leadership, influencing program decisions through scientifically sound and risk-based recommendations
- Provides strategic oversight of DMPK activities across multiple discovery and development programs, including IND- and NDA-enabling studies, ensuring consistency of scientific approaches and alignment with organizational objectives
- Influence portfolio decisions through integrated interpretation of DMPK data, risk assessments, and strategic recommendations regarding asset progression and development plans
- Review, analyze and interpret scientific data and results for DMPK studies and integrate findings into overall nonclinical assessments and development strategies
- Manage outsourcing and study activities, study timelines, budgets, and deliverables for assigned programs
- Act as author/co-author and reviewer of regulatory documents
- Collaborate within the nonclinical team to incorporate new guidance requirements
- Analyze competitive scientific knowledge from external sources
- Establish and maintain scientific standards, best practices, and technical guidance across the Nonclinical DMPK function
- Contribute to continuous improvement initiatives, scientific standards, and implementation of evolving regulatory guidance for Nonclinical drug assessments
Qualifications/ Required- MSc or PhD in Chemistry, Biology, Pharmaceutical Sciences, or related area with at least 7 years of experience in a pharmaceutical company or contract research organization
- Proven track record in delivering discovery and early development assets to the clinic and POC
- Strong technical experience in planning and executing nonclinical studies
- Thorough knowledge of regulatory requirements and the overall drug development process
- Regulatory expertise preferred, including successful IND/CTA submissions
- Ability to assess and prioritize tasks as business needs change and manage multiple programs simultaneously
- Detail-oriented with strong written and verbal communication skills, and demonstrated ability to work in cross-functional project teams
CompetenciesAccountability 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.
CompetenciesAccountability 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 $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.
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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.
