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 supporting oncology compound development at Taiho Oncology, Inc. The role bridges preclinical research and late-stage clinical development, using modeling approaches such as population pharmacokinetics (PopPK), exposure–response (ER), and quantitative systems pharmacology (QSP) to support safe, effective, and regulatory-ready drug candidates. The Senior Director develops clinical pharmacology strategies and reporting plans, integrates pharmacokinetic data and analyses into clinical trials and regulatory documents, and works across clinical development, biostatistics, clinical operations, regulatory, data science, biomarker, and related groups. The role also manages and mentors the clinical pharmacology team, represents clinical pharmacology on Global Development Teams, and collaborates with Taiho Pharmaceutical Japan’s PK department.
Requirements
- At least 12 years of industry experience focused on clinical development, including oncology.
- 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.
- Significant experience with PK, PK/PD, and modeling and simulation, including PopPK, exposure–response, and QSP analyses in clinical trials.
- Experience designing and executing clinical pharmacology and PK studies in oncology.
- Operational experience in clinical pharmacology/PK aspects of oncology clinical development.
- Working knowledge of ICH, FDA, and EU clinical pharmacology/PK guidelines.
- Prior experience working on interdisciplinary teams.
- Demonstrated success managing a team and willingness to prioritize organizational and team needs.
- Deep working knowledge of the drug development process.
- Strong written and oral communication skills.
- 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/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 is highly desirable.
Responsibilities
- Develop overall clinical pharmacology strategy and reporting plans for oncology compounds in Taiho Oncology-sponsored clinical trials.
- Write or oversee clinical pharmacology and pharmacokinetics sections of Phase I–III trials.
- Review and finalize clinical pharmacology and pharmacokinetics sections of Statistical Analysis Plans.
- Develop and execute computational modeling strategies, including PK/PD, exposure–response, and QSP analyses.
- Collaborate with Clinical Development, Biostatistics, Clinical Operations, and Regulatory to incorporate PK and clinical pharmacology activities into protocols, clinical study reports, and regulatory submissions.
- Support regulatory submissions by writing or reviewing clinical pharmacology components of regulatory documents.
- Integrate clinical trial data, real-world data, patient characteristics, and disease biology to optimize dose selection, dosing regimens, and study designs.
- Curate, visualize, and manage complex datasets from multiple sources.
- Integrate pharmacometric workflows using 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 other departments to integrate PK-related data into company activities.
- Collaborate with the biomarker department and conduct PK/PD analyses.
- Maintain collaboration with the PK department at Taiho Pharmaceutical Japan.
- Manage, supervise, and mentor members of the Taiho Oncology clinical pharmacology team.
- Perform other duties as assigned.
Benefits
- Annual bonus/incentive compensation plans may be included.
- Potential long-term incentive plan and discretionary awards may be included.
- 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
