Associate Director, Quantitative Pharmacology, Clinical Pharmacology

Otsuka Pharmaceutical Co., Ltd; Princeton (NJ); Hybrid; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Paid holidays

Paid leave

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking a senior professional to lead clinical pharmacology activities across pre-IND to development stages in the United States.

The role includes study design, protocol development, PK/PD analyses, and regulatory submission input. You will work closely with pharmacometrics, bioanalysis, formulation, and development teams, mentoring staff and guiding model-based drug development strategies.

Qualifications

• In-depth knowledge of clinical pharmacology and PK/PD analyses.
• Experience with regulatory filings and drug development.
• Ability to lead cross-functional teams and mentor staff.

Responsibilities

• Design and oversee clinical pharmacology studies and PK/PD analyses.
• Prepare pharmacology sections for regulatory submissions and reports.
• Lead modeling and simulation activities and collaborate with pharmacometrics.

Skills

Leadership

Organization

Communication

Clinical pharmacology

Education

PhD/PharmD/MS in Clinical Pharmacology

Tools

Phoenix NLME

Job description

**Job Summary**Supports all **clinical pharmacology** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Supports study design, execution and reporting of **clinical pharmacology** and studies. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. Closely interacts with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author of **clinical pharmacology** submission documents and representative of the department at different product development team meetings. participates in pharmacometrics and simulation and modeling plans and provide input on modeling and simulation activities. Interacts with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and early phase assets.**Job Description*** Supports clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.* **Conduct PK and PK/PD analysis**.* Work closely with pharmacometrics team members and provides input related to analysis and reporting of PK and PK/PD.* Authors development of **clinical pharmacology** sections for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans.* Work with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics and biomarker development.* Work with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.* Manage clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.* Training and mentoring of staff related to **clinical pharmacology*** Serve as **clinical pharmacology lead** and pharmacometrics representative on multiple project teams and **support model-based drug development strategies** for ongoing projects**.****Qualifications/ Required**Knowledge/ Experience and Skills:**Knowledge and Competencies** • In-depth knowledge of **clinical pharmacology**, **PK, PD, drug metabolism, biopharmaceutics**, and **bioanalytica**l chemistry, Hands PK and PK/PD analysis and, **Phoenix NLME**, etc. • Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis. • Great working knowledge of formulation development, drug development and clinical development. • Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents.**Skills** •Must be able to apply scientific knowledge (in the areas specified above) to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.•Strong leadership experience related to **clinical pharmacology**. •Strong organization skills. •Strong communication skills. •Flexibility to react rapidly to changing situations/environment. Travel 20%**Educational Qualifications**PhD, PharmD, MS in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of **5** years of experience in these areas. Experience in population PK and PK/PD modeling and statistical models a plus.**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.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, and paid leave programs as well as other company provided benefits.