Job Description
Role Overview
We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.
Associate Directors are emerging leaders in the field of quantitative drug development, with a developing understanding of the strategic elements of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions on drug development teams.
Primary Responsibilities:
Serving as an expert representative for QP2-IO on Oncology clinical development teams.
Framing critical questions for optimizing model-based analyses on programs.
Developing and executing 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, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.
Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.
Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.
Minimum EducationOR
Required Experience and SkillsDemonstrated 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 programing language.
Professional working proficiency in written and verbal communication.
This opportunity will be hybrid or remote, but the remote position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, the position will be hybrid. Please note that standard commute is (less than) <50 miles."
#QP2
#EligibleforERP
Required Skills:
Clinical Development, Clinical Pharmacology, Communication, Data Modeling, Dose Response Analysis, Drug Development, Machine Learning (ML), Model Driven Development, Modeling Simulations, Modeling Software, Pharmaceutical Development, Pharmacometrics, Stakeholder Relationship Management
Preferred Skills:
NONMEM, Oncology, Oncology Drug Development, Phoenix WinNonlin, PKPD Modeling, Population Pharmacokinetics, Regulatory Writing
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
07/31/2026
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
