Senior Director, Oncology Clinical Pharmacology & Modeling

Taiho Oncology, Inc.; Pleasanton (CA); Ibrido; USD 264.000 - 310.000; Tempo pieno

Descrizione del lavoro

Taiho Oncology, Inc. is seeking a Senior Director of Clinical Pharmacology & Pharmacometrics to lead CP/PK activities for oncology programs. This hybrid role combines on-site presence with collaboration across functions at our Pleasanton, CA location.

You will oversee modeling & simulation, PK/PD analyses, and dose selection, guiding CP strategy and regulatory submissions while mentoring a team of scientists in a fast-paced environment.

Competenze

• A minimum of 12 years of industry experience with focus on clinical development including oncology.
• Significant PK/PD and modeling & simulation experience (PopPK, ER, QSP) in clinical trials.
• Operational CP/PK experience in oncology development.
• Knowledge of ICH/FDA/EU CP/PK guidelines.
• Interdisciplinary team experience and strong communication skills.
• Experience with regulatory NDA/BLA submissions is desirable.
• Deep understanding of the drug development process.

Mansioni

• Develop CP strategy and reporting plans for oncology compounds in TOI trials.
• Write or oversee CP/PK sections of Phase I-III trials.
• Collaborate with teams to integrate CP into protocols and regulatory documents.
• Mentor junior scientists and lead quantitative modeling efforts.

Conoscenze

Clinical pharmacology

Pharmacometric modeling

PK/PD analysis

Team leadership

Regulatory submissions

Data integration

Modeling & Simulation

Formazione

Advanced degree (PhD preferred)

Strumenti

WinNonlin

Data Management software

MS Office

Descrizione del lavoro

Taiho Oncology, Inc. is seeking a Senior Director of Clinical Pharmacology & Pharmacometrics to lead CP/PK activities for oncology programs. This hybrid role combines on-site presence with collaboration across functions at our Pleasanton, CA location.

You will oversee modeling & simulation, PK/PD analyses, and dose selection, guiding CP strategy and regulatory submissions while mentoring a team of scientists in a fast-paced environment.