Associate Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (QP2‑IO)

Our company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. We are recognized as an industry leader in immuno-oncology (IO) and vaccines discovery and development. For more than a century, we have translated scientific innovation into medicines and vaccines that improve and save lives worldwide—anchored in ethical integrity, scientific excellence, and a clear mission to transform global health. We are committed to being the world’s premier, most research-intensive biopharmaceutical company.

About the role

We are seeking an experienced scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team as an Associate Director. The QP2-IO team is part of the Global Clinical Development organization and oversees drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Associate Directors are emerging leaders in quantitative drug development, contributing to the development of novel chemical entities and strategizing quantitative analyses within and across development programs. This role involves close collaboration with cross-functional teams, external vendors, and partners to create an aligned, quantitative framework impacting drug development strategies and decisions.

This opportunity is hybrid or remote, with remote positions available only for those not within commutable distance to primary sites.

Responsibilities

• Serve as an expert representative for QP2-IO on Oncology clinical development teams.
• Frame critical questions for optimizing model-based analyses on programs.
• Develop and execute model-based analyses, including:
  • Translational PK/PD approaches
  • Population pharmacokinetic models
  • Exposure-response models
  • Clinical trial simulation
  • Disease progression models
  • Quantitative systems pharmacology (QSP) modeling
  • Comparator modeling
• Strengthen pharmacometrics capabilities in decision-making and drive pipeline impact.
• Strategize and execute modeling of tumor size and survival endpoints, including proportional hazards models.
• Maintain a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology.
• Author regulatory documents (INDs, CSRs, CTDs) and represent QP2-IO at regulatory meetings.

Requirements

• Ph.D. with at least 3 years of experience OR PharmD, MS, or equivalent degree with preferably 5-7 years of relevant experience in pharmaceutical drug development, demonstrating increasing responsibility and independence.
• Demonstrated impactful experience with applications of pharmacometrics methods.
• Skills in experimental design, mathematical problem-solving, critical data analysis/interpretation, and statistics.
• Proficiency in R, NONMEM, or other similar programming languages.
• Professional working proficiency in written and verbal communication.

Preferred Skills

• NONMEM
• Oncology and Oncology Drug Development
• Phoenix WinNonlin
• PKPD Modeling
• Population Pharmacokinetics
• Regulatory Writing

Pay

The salary range for this role is $156,900.00 - $247,000.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Comprehensive medical, dental, and vision healthcare for employee and family
• Retirement benefits, including 401(k)
• Paid holidays, vacation, compassionate, and sick days

More information about benefits is available at Merck Compensation and Benefits.

VISA sponsorship is available for this role. Travel requirements are approximately 10%.