Sr. Director, Clinical Pharmacology & Pharmacometrics

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our "People first" approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.


Hybrid


Employee Value Proposition:


Oversee Clinical Pharmacology activities in support of development of Taiho programs.

Position Summary:


Position will be in charge of the clinical pharmacology (CP) and pharmacokinetics (PK) activities related to oncology compound development for Taiho Oncology, Inc. (TOI).

Performance Objectives:

• Develop the overall CP strategy and reporting plans for oncology compounds developed in TOI-sponsored clinical trials by:
  • Writing or overseeing the writing of all CP/PK sections of Phase I-III trials
  • Reviewing the finalization of all CP/PK-related sections of Statistical Analysis Plans
  • Collaborating with Clinical Development, Biostatistics, Clinical Operations and Regulatory to incorporate the bioanalysis for PK and CP components and activities into the final protocols.
• Final analysis and reporting of bioanalysis for PK and CP data generated by TOI-sponsored clinical trials and writing or reviewing the appropriate sections of the following documents:
  • Clinical Study Reports
  • Investigator Brochures
  • Regulatory Documents, including NDAs and MAAs and responses to questions from regulatory authorities.
  • Academic publications, including scientific meeting abstracts and peer-reviewed articles.
• CP representative for specific programs in Global Development Teams
• Lead the implementation of bioanalytical activities for CP/PK by:
  • Arranging what external or Taiho Pharmaceutical Company laboratories and systems will be used to do the bioanalytical work for PK samples retrieved in TOI run clinical trials.
  • Leading and providing the technical component of contracting with external bioanalysis vendors.
  • Collaborating closely with related departments such as data management, biostatistics, clinical operations etc. to ensure full and effective integration of bioanalysis within TOI activities.
• Collaboration with biomarker department and conduct PK/PD analysis (pharmacodynamic)
• Maintain collaboration with TPC (Taiho Pharmaceutical Japan) PK department
• Build CP department at TOI and provide supervision/mentorship as needed.

Education/Certification Requirements:

• Advanced degree ( Doctoral or Ph.D. is preferable ) in pharmacology-related discipline. If a candidate has a master's degree, additional industry experience will be required.

Knowledge, Skills, and Abilities:

• A minimum of 10 years of industry experience with focus on clinical development including oncology.
• Significant experience of PK, and PK/PD analyses in clinical trials and the design and execution of CP and PK studies in oncology.
• Operational experience in CP/PK part of oncology clinical development.
• A working knowledge of the ICH/FDA/EU guidelines for CP/PK.
• Prior experience working in an interdisciplinary team
• Excellence in written and oral communication.
• Demonstrated experience successfully managing a team and willingness to put the organization and team's needs first.
• Experience with prior regulatory interactions, NDA/BLA submissions highly desirable.
• Deep working knowledge of drug development process.
• Ability to multi-task.
• Attention to detail with a consistent focus on quality.
• Ability to read, analyze, and interpret professional journals and technical manuscripts.
• Ability to write reports, and procedures.
• Ability to effectively present information and respond to questions from internal and external clients.
• Ability to appropriately analyze CP/PK related data including pop-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 and MS Office products specifically Word, Excel, PowerPoint, and WinNonlin.
• The employee is required to understand documents in English.

The pay range for this position at commencement of employment is expected to be between $263,000 - $310,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.


If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.


#LI-Hybrid , #LI-Princeton, #LI-Pleasanton Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email [email protected] . Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties, as assigned.