Director, Quantitative Pharmacology, Clinical Pharmacology

Otsuka; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director of Quantitative Pharmacology to lead clinical pharmacology activities in drug development. This pivotal role involves overseeing the design and execution of clinical studies, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams. The ideal candidate will have a PhD in Clinical Pharmacology and a wealth of experience in pharmacokinetics and pharmacodynamics. Join a forward-thinking company that values innovation and accountability, where your expertise will directly impact the development of groundbreaking healthcare solutions. If you are passionate about advancing medical science and thrive in a dynamic environment, this opportunity is perfect for you.

Qualifications

• 10+ years of experience in clinical pharmacology and drug development.
• Hands-on experience with PK and PK/PD analysis using professional software.

Responsibilities

• Oversee clinical pharmacology activities for drug development and regulatory submissions.
• Lead study design, execution, and reporting of clinical pharmacology studies.

Skills

Clinical Pharmacology

Pharmacokinetics (PK)

Pharmacodynamics (PD)

Leadership

Communication Skills

Problem Solving

Organizational Skills

Education

PhD in Clinical Pharmacology

Tools

Phoenix NLME

WinNonLin Phoenix

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 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:

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.