Director, Quantitative Pharmacology, Clinical Pharmacology

Otsuka Pharmaceutical Co.; Rockville (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player seeks a Director of Quantitative Pharmacology to lead clinical pharmacology activities in drug development. This role involves overseeing study design, execution, and regulatory submissions, ensuring optimal strategies for drug development. The ideal candidate will have a PhD and extensive experience in clinical pharmacology, with a strong focus on PK and PD analysis. Join a team dedicated to innovative healthcare solutions, where your expertise will drive impactful results in improving health outcomes worldwide. If you're passionate about advancing pharmaceutical science, this opportunity is perfect for you.

Qualifications

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism.
• Hands-on experience in PK and PK/PD analysis using professional software.

Responsibilities

• Oversee clinical pharmacology activities related to drug development.
• Lead study design, execution, and reporting of clinical pharmacology studies.

Skills

Clinical Pharmacology

Pharmacokinetics (PK)

Pharmacodynamics (PD)

Problem Solving

Leadership

Communication

Organization

Education

PhD in Clinical Pharmacology

Tools

WinNonLin Phoenix

Phoenix NLME

Job description

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 a Director, Quantitative Pharmacology, Clinical Pharmacology, you will oversee all clinical pharmacology activities related to pre-IND, IND, phase 1-3, Pharmacokinetics (PK), Pharmacokinetics-Pharmacodynamics (PK/PD) and regulatory submissions. You will lead study design, execution and reporting of clinical pharmacology studies. You will contribute to all phases of drug development including dose finding, dose optimization, exposure-response and pediatric development. You will interact with non-clinical, translational medicine, and biomarker/bioanalytical team members for design and execution of first-in-human, proof of concept (PoC), mass balance and drug interaction studies. The Director will author/review clinical pharmacology submission documents and represent the department at different product development team meetings. You will participate in pharmacometrics and simulation and modeling plans and provide input on modeling and simulation activities. You will interact with early development and business development team members and external collaborators to assess/lead development and selection of pre-IND and early phase assets.

Job Description

• 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 pediatric 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:

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.

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.