Sr. Manager, Clinical Pharmacology & Pharmacometrics

Merck & Co.; Pleasanton (CA); Hybrid; USD 157,000 - 185,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Taiho Oncology is seeking a Clinical Pharmacology and Pharmacometrics Expert to lead PK/PD analyses for the TOI oncology portfolio. You will represent CP on project teams, design studies, and guide regulatory submissions across healthy volunteers and patients.

The role requires a PhD/PharmD or equivalent and a minimum of 5 years of hands-on PK expertise. A hybrid work model is available in Princeton, NJ and Pleasanton, CA with strong collaboration across functions.

Qualifications

• PhD, PharmD or equivalent in pharmacokinetics, pharmaceutics, pharmacology, or similar area.
• Minimum 5 years' experience, including postdoctoral fellowship; seniority commensurate with experience.
• Hands-on PK analysis and modeling experience required.

Responsibilities

• Oversee design, analysis, interpretation and reporting of PK/PK-PD data from clinical studies.
• Lead CP programs and contribute to regulatory documents.
• Plan study designs, analysis plans, and data interpretation for regulatory filings.
• Collaborate with cross-functional teams to translate findings into development plans.

Skills

PK analysis

Pharmacometric modeling

Regulatory writing

Cross-functional leadership

Data interpretation

Education

PhD, PharmD or equivalent

Tools

PK/PD software

Biostatistics tools

Job description

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:

At Taiho Oncology, we recognize the critical role that Clinical Pharmacology and Pharmacometrics (CPP) plays in the development of oncology compounds. Our Performance Objectives outline a comprehensive approach to developing the overall CPP strategy and reporting plans for all TOI-sponsored clinical trials, ensuring the success of our drug development endeavors. This role will serve as Clinical Pharmacology (CP) Expert on Project teams and lead CP program(s).

Position Summary:

• This role is responsible for overseeing the design, analysis, interpretation, and reporting of pharmacokinetic, pharmacodynamic, drug disposition, and drug metabolism data from clinical studies for TOI oncology portfolio and representing Clinical Pharmacology function at Project Teams and Clinical Study Teams.

Performance Objectives:

• Responsible for performing pharmacokinetic analysis and PK and PK/PD modeling and simulations; lead/author, or contribute to relevant sections of Clinical Study Reports, Clinical Pharmacology related regulatory documents and draft relevant sections in support of clinical development plans, and provide Clinical Pharmacology and Pharmacometrics perspective on cross-functional teams, including Clinical Study Teams.
• Plan and review study designs, analysis plans, data analysis, and interpretation of PK, PK/PD, as well as planning, implementation and organization of regulatory filings and presentation of data at cross-functional teams, department meetings, conferences, and regulatory meetings. Serve as a study director for Clinical Pharmacology studies in healthy volunteers.
• Review PK/PD and bioanalytical data. Oversee the Data Transfer Agreements with vendors.
• Contribute to the design and development of Clinical Pharmacology studies, including DDI, Food Effect, ADME, and related studies, as well as the translation of findings into an understanding of in vivo metabolic fate.
• Work closely with other scientists and disciplines, including Biostatistics, Data Management, Translational Pharmacology, Pharmaceutical Development, CMC, Toxicology, Clinical Development, and other relevant groups, to plan, analyze and interpret PK, biotransformation, and metabolism data.
• Contribute to improvements in processes within the department as well as across functional areas affecting Clinical Pharmacology, such as Biostatistics, Drug Safety and Clinical Operations.

Education/Certification Requirements:

• PhD, PharmD or equivalent in pharmacokinetics, pharmaceutics, pharmacology, or similar area.

Knowledge, Skills, and Abilities:

• Minimum 5 years' experience, including postdoctoral fellowship; position title commensurate with experience.
• Hands-on experience with PK analysis and generating outputs.
• Experience with industry standard PK, PK/PD pharmacometrics software and tools.
• Strong interpersonal skills and ability to effectively manage external consultants and third-party CROs.
• Strong problem solver who is highly organized with the ability to lead in an environment with rapidly changing priorities.
• Strong written, presentation, and verbal communication skills are essential.

The pay range for this position at commencement of employment is expected to be between $ $157,250 - $185,000 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, #Location-Princeton,NJ / #Location-Pleasanton, CA

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 [e-mail] . 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.