Sr. Director, Clinical Pharmacology & Pharmacometrics
About The Position
The Senior Director, Clinical Pharmacology & Pharmacometrics, Modeling and Simulation provides scientific and strategic leadership across clinical pharmacology, pharmacometrics, and modeling and simulation activities for oncology compound development at Taiho Oncology, Inc. The role bridges preclinical research and late-stage clinical development, using pharmacology data and modeling approaches to support safe, effective, and regulatory-ready drug candidates. The Senior Director develops clinical pharmacology strategies and reporting plans for oncology compounds in company-sponsored clinical trials. The role leads and oversees pharmacokinetic and clinical pharmacology content in trial documents and regulatory submissions, and applies approaches including population pharmacokinetics, exposure–response modeling, PK/PD, and quantitative systems pharmacology to guide dose selection, dosing regimens, and study design. The position also integrates complex datasets and modern data-science and computing workflows into pharmacometric analyses. As a cross-functional and people leader, the Senior Director represents clinical pharmacology on Global Development Teams, collaborates with clinical development, biostatistics, clinical operations, regulatory, data management, biomarker, and data science colleagues, and maintains collaboration with Taiho Pharmaceutical Japan’s PK department. The role manages and mentors clinical pharmacology team members and contributes to scientific publications.
Requirements
- Advanced degree in a pharmacology-related discipline or quantitative sciences; a doctoral degree or Ph.D. is preferred. Candidates with a master's degree require additional industry experience.
- At least 12 years of industry experience focused on clinical development, including oncology.
- Significant experience with PK, PK/PD, and modeling and simulation, including population PK, exposure–response, and QSP analyses in clinical trials, as well as the design and execution of oncology clinical pharmacology and PK studies.
- Operational experience in the clinical pharmacology and PK components of oncology clinical development.
- Working knowledge of ICH, FDA, and EU clinical pharmacology and PK guidelines.
- Prior experience working in an interdisciplinary team.
- Excellent written and oral communication skills.
- Demonstrated experience managing a team successfully and willingness to prioritize organizational and team needs.
- Deep working knowledge of the drug development process.
- Ability to multitask and maintain attention to detail and quality.
- Ability to read, analyze, and interpret professional journals and technical manuscripts.
- Ability to write reports and procedures.
- Ability to present information effectively and respond to questions from internal and external clients.
- Ability to analyze clinical pharmacology and PK data, including population PK analysis and modeling.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret abstract and concrete concepts.
- Experience using data management software, Windows, Microsoft Word, Excel, PowerPoint, and WinNonlin.
- Ability to understand documents in English.
Nice To Haves
- Prior experience with regulatory interactions and NDA/BLA submissions.
Responsibilities
- Develop overall clinical pharmacology strategy and reporting plans for oncology compounds in Taiho-sponsored clinical trials.
- Write or oversee writing of clinical pharmacology and pharmacokinetic sections for Phase I–III trials.
- Review clinical pharmacology and pharmacokinetic sections of Statistical Analysis Plans.
- Develop and execute computational modeling strategies, including PK/PD, exposure–response, population pharmacokinetic, and quantitative systems pharmacology analyses.
- Collaborate with Clinical Development, Biostatistics, Clinical Operations, and Regulatory to integrate PK and clinical pharmacology activities into protocols, clinical study reports, and regulatory submissions.
- Write or review clinical pharmacology components of regulatory documents.
- Integrate clinical trial, real-world, patient-characteristic, and disease-biology datasets to optimize dose selection, dosing regimens, and study designs.
- Curate, visualize, and manage large, complex datasets from multiple sources.
- Integrate pharmacometric workflows with modern data architecture, data science engineering, and advanced computing.
- Collaborate with cross-functional teams to implement modeling solutions.
- Contribute to academic publications, scientific meeting abstracts, and peer-reviewed articles.
- Mentor and lead junior scientists in quantitative modeling efforts.
- Represent Clinical Pharmacology for assigned programs on Global Development Teams.
- Coordinate with data management, biostatistics, clinical operations, and related departments to integrate PK-related data into company activities.
- Collaborate with the biomarker department and conduct pharmacodynamic PK/PD analyses.
- Maintain collaboration with the Taiho Pharmaceutical Japan PK department.
- Manage and supervise or mentor members of the TOI Clinical Pharmacology department.
Benefits
- Potential annual bonus or incentive compensation plans.
- Potential long-term incentive plan and discretionary awards.
- Medical, financial, and other benefits.
- 401(k) eligibility.
- Paid time off benefits, including vacation and sick time.
- Parental leave.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
