Director, Quantitative Pharmacology, Clinical Pharmacology

Georgia Pharmacy Association; United States; Remote; USD 130,000 - 180,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Director of Quantitative Pharmacology. The ideal candidate will oversee clinical pharmacology strategies and lead cross-functional project teams, ensuring drug development compliance. With a PhD and extensive experience, you will play a pivotal role in shaping the future of clinical pharmacology within the organization. Responsibilities include regulatory filings, study design, and the use of innovative analytical methods to optimize drug dosing strategies.

Qualifications

• PhD in Clinical Pharmacology or related field with at least 10 years of related experience.
• Experience with population PK and PK/PD modeling is a plus.
• Hands-on experience in PK/PD analysis.

Responsibilities

• Lead clinical pharmacology activities in study design, protocol development, and data interpretation.
• Develop clinical pharmacology sections for regulatory filings including IND/NDA/BLA applications.
• Train and mentor junior team members in Quantitative Pharmacology team.

Skills

Leadership

Communication

Problem Solving

Analytical Skills

Organizational Skills

Education

PhD in Clinical Pharmacology or related area

Tools

WinNonLin Phoenix

Phoenix NLME

Job description

Job Description

https://vhr-otsuka.wd1.myworkdayjobs.com/External/job/Remote/Director--Quantitative-Pharmacology--Clinical-Pharmacology_R9036

• Serve as clinical pharmacology lead on multiple cross-functional project teams, plan and optimize clinical pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory packages.
• Lead clinical pharmacology activities related to study design, protocol development, study execution, data interpretation and study reporting. Conduct or oversee PK and PK/PD analysis using professional software, e.g., WinNonLin Phoenix. Responsible for ensuring appropriate PK-PD analysis is planned, performed and presented. Author PK reports that are integrated into clinical and regulatory documents.
• Lead development of clinical pharmacology sections for regulatory filings, including annual reports, investigator's brochure, IND/NDA/BLA applications and pediatrics development plans in compliance with relevant guidelines and standards.
• Work with pharmacometricians, support model-based drug development (MIDD) strategies, and provide input to PK and PK/PD modeling analysis to support dose selection, efficacy and safety assessments.
• Responsible for use of innovative analytical methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics, biomarker, statistics and clinical development functions (as relevant).
• Interact cross-functionally across other key disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory, and CMC. Work with formulation, biomarker and bioanalytical team members on activities related to formulation, development, assay development, sample management, Pharmacogenomics (PGx) and biomarker strategy development.
• Train and mentor junior team members in Quantitative Pharmacology team

Qualifications/ Required Knowledge/ Experience and Skills:

https://vhr-otsuka.wd1.myworkdayjobs.com/External/job/Remote/Director--Quantitative-Pharmacology--Clinical-Pharmacology_R9036

Knowledge and Competencies

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
• Hands-on experiences in PK and PK/PD analysis and using professional software, Phoenix NLME, etc.
• Excellent working knowledge of phase I study design, clinical trial operations, multi-region regulatory requirements and PK/PD analysis.
• Practical working experience in a multi-discipline project team, familiar with cross-functional collaboration.
• Great working knowledge of formulation development, clinical drug development and regulatory process.
• 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 in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 10 years of experience in these areas. Experience in population PK and PK/PD modeling and statistical models a plus.