Associate Director, Non-clinical Drug Safety

Otsuka Pharmaceutical Co., Ltd; United States; A distancia; USD 169.000 - 253.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive medical

dental

vision

prescription drug coverage

basic life

accidental death & dismemberment

short-term disability

long-term disability

tuition reimbursement

student loan assistance

a generous 401(k) match

flexible time off

paid holidays

paid leave programs

other company provided benefits.

Descripción de la vacante

Otsuka Pharmaceutical Co., Ltd seeks an Associate Director of Non-clinical Drug Safety to lead design, execution, and evaluation of non-clinical safety for small molecules and biologics. You will guide cross-functional teams on safety strategies and regulatory deliverables including INDs, NDAs/BLAs, and briefing books.

Role requires oversight of GLP toxicology studies, review of data, and communication of risk assessments to senior leadership.

Formación

• MSc or PhD in Toxicology, Pharmacology or related areas with at least 7 years of experience in a pharmaceutical company or contract research organization.
• Diplomate of the American Board of Toxicology (DABT) is highly desired.
• Strong preference to experience in Biologics
• 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 switch tasks and priorities as business needs change and manage multiple programs simultaneously

Responsabilidades

• Serve as the toxicology subject matter expert on cross-functional discovery and development teams and provide strategic nonclinical safety recommendations to support program progression and development decision-making
• Lead and oversee IND and NDA enabling GLP toxicology studies
• Review, analyze and interpret scientific data and results for toxicology studies and integrate findings into overall nonclinical safety assessments and development strategies
• Manage outsourcing and study activities, study timelines, budgets, and deliverables for assigned programs
• Communicate toxicology findings and risk assessments to project teams and senior leadership, influencing program decisions through scientifically sound and risk-based recommendations
• 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
• Contribute to continuous improvement initiatives, scientific standards, and implementation of evolving regulatory guidance within Nonclinical Drug Safety

Conocimientos

Nonclinical toxicology

GLP toxicology studies

Regulatory submissions

Data interpretation and risk analysis

Outsourcing management

Educación

MSc or PhD in Toxicology/Pharmacology or related

DABT (desirable)

Descripción del empleo

Job Summary

The Associate Director, Non-clinical Drug Safety is responsible for technical and scientific matters related to the design, execution and evaluation of non-clinical safety and toxicology for small molecules and biologics. The role independently leads nonclinical safety strategies for assigned development programs and provides expert scientific guidance to cross-functional teams to support program advancement and regulatory objectives. This includes the preparation of regulatory documents such as INDs, NDAs/BLAs, aggregate reports, fast track designation, 8-FA, ICFs, and briefing books.

Job Description

• Serve as the toxicology subject matter expert on cross-functional discovery and development teams and provide strategic nonclinical safety recommendations to support program progression and development decision-making


• Lead and oversee IND and NDA enabling GLP toxicology studies


• Review, analyze and interpret scientific data and results for toxicology studies and integrate findings into overall nonclinical safety assessments and development strategies


• Manage outsourcing and study activities, study timelines, budgets, and deliverables for assigned programs


• Communicate toxicology findings and risk assessments to project teams and senior leadership, influencing program decisions through scientifically sound and risk-based recommendations


• 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


• Contribute to continuous improvement initiatives, scientific standards, and implementation of evolving regulatory guidance within Nonclinical Drug Safety

Qualifications / Required

• MSc or PhD in Toxicology, Pharmacology or related areas with at least 7 years of experience in a pharmaceutical company or contract research organization


• Diplomate of the American Board of Toxicology (DABT) is highly desired.


• Strong preference to experience in Biologics


• 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 switch tasks and priorities as business needs change and manage multiple programs simultaneously

Detail-oriented with strong written and verbal communication skills

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

Minimum $169,222.00 - Maximum $253,000.00, 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


• paid leave programs


• other company provided benefits.

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].