Associate Director, Nonclinical Safety and Dmpk

2 weeks ago

Rockville, United States Otsuka Full time

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

As an Associate Director, Nonclinical Safety and DMPK, you will be a champion of Otsuka’s culture and values and will provide support to ongoing and planned nonclinical programs at various stages of development. You will collaborate with Quantitative Pharmacology, Bioanalytical, and Translational Sciences to support early and late phase drug development.

You will report to the Director of Non-Clinical Drug Safety and DMPK.

This position is based in Rockville, Maryland or Princeton, New Jersey. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs.

**Job Description**:
- Review, evaluate, interpret, report, and compile non-clinical toxicology, pharmacology, ADME, and drug safety data.- Oversee, design, and report on nonclinical studies in accordance with international regulatory requirements.- Manage contract laboratories and ensure delivery of high-quality nonclinical reports that meet regulatory requirements.- Author nonclinical sections of applicable nonclinical sections in INDs, IBs, annual reports and NDAs.- Develop mitigation strategies for project safety risks using traditional and novel toxicological tools.- Work with Translational Sciences to develop or validate model systems, techniques, and computational tools to support drug development.- Present research findings at scientific meetings and conferences and through manuscripts in peer-reviewed journals.

Minimum Qualifications:
- Doctoral degree in pharmacology, toxicology, biology or a related scientific field is required.- Board Certification or eligibility in ATS, DABT, DACVP, or related certification is required.- 5 years of experience in toxicology in a pharmaceutical or consumer product industry is required.- Background in pharmacology, toxicology, pathology, DMPK, drug development, and global regulatory requirements is required.- Complete understanding of the current scientific advancements in the field.- Proficient knowledge of toxicology of small molecules and biologics.- Good knowledge of the drug discovery and development processes.- Working knowledge of nonclinical regulatory guidelines.

Preferred Knowledge, Skills, and Abilities:
- Excellent communication and presentation skills.- Strong scientific background and critical thinking skills.- Proficient computer skills with demonstrated experience working with the Microsoft Office suite.- Experience in early drug development of CNS, oncology, cardiorenal, and/or immunoinflammatory diseases.- Experience working with and managing studies at external vendors.

Our Benefits:
- Comprehensive medical, dental, vision and prescription drug coverage-
- Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance-
- Tuition reimbursement-
- 401(k) match-
- PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.- #LI-Hybrid

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.

Come discover more about Otsuka and our benefit offerings;

- 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.- Accommodation Request
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To ensure tha

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