Job Description
Job Description The Toxicokinetics group within the Translational Modeling group of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) in West Point, PA is seeking a highly motivated Associated Principal Scientist with wide knowledge of pharmacokinetic (PK) and toxicokinetic (TK) principles and modeling techniques. The individual will be responsible for executing all phases/aspects of toxicokinetics support of nonclinical toxicity studies [ie, exploratory and definitive/Good Laboratory Practice (GLP)], serving as a contributing scientist/principal investigator on toxicity studies, and executing PK/TK strategies to support the development of small molecules and biologics.
The successful candidate will collaborate on cross-functional teams to ensure analytical solutions and interpretations are appropriate to address program goals or capability gaps. They will interpret results in the context of the toxicological question at hand and clearly and effectively deliver conclusions to stakeholders. They will thrive in a dynamic work environment. They will demonstrate practical problem-solving skills and the ability to communicate effectively both verbally and in writing.
Key Responsibilities: - Serve as a contact for all TK-related issues pertinent to the development of assigned drug candidates and closely interact with toxicology study directors, project representatives, bioanalytical scientists, drug metabolism and translational modeling representatives, and other relevant functional areas.
- Serve as a contributing scientist on toxicology studies, and execute all phases/aspects of the toxicokinetics evaluation with minimum supervision. Essential duties include, but are not limited to the following: conduct TK modeling to support dose-selection on toxicity studies, provide TK study design, calculate PK/TK parameters, interpret results, and write reports to a high standard in accordance with external and internal regulations.
- Ensure compliance with GLP, SOPs, and study protocols.
- Deliver high quality scientific results according to agreed timeline for several concurrent studies.
- Effectively communicate study results at internal meetings, as appropriate.
- Mentor junior-level staff as appropriate
- Participate on due diligence projects for toxicokinetic evaluation of nonclinical programs.
- Future potential to represent the department on cross-functional early drug development project teams of drug candidates, responsible for providing departmental strategy, and authoring nonclinical sections of regulatory filings.
- Identify opportunities for process improvements and participate in cross-functional efforts to improve quality and efficiency.
Note: We are hiring in South San Francisco, CA, Boston, MA or West Point, PA based on candidate preference. Qualifications: Education: - Master's (with 8+ years) or Ph.D. (with 3+ years) in Pharmacokinetics, Toxicology, Pharmacology or related scientific discipline and relevant experience listed below
Required Experience and Skills: - Strong knowledge of pharmacokinetics/toxicokinetics, pharmacokinetic modeling (NCA analysis, nonparametric superposition, and compartmental PK modeling), and drug metabolism is required with demonstrated hands-on proficiency with Phoenix
- Strong leadership, interpersonal, communication, problem solving, and collaboration skills, with ability to work independently, along with strengths in delivering results for multiple projects in a fast-paced environment
Preferred Experience and Skills: - Knowledge and experience in PK/PD fundamentals
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U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote".
The salary range for this role is
$156,500.00 - $246,300.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several 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.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully 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/International
VISA Sponsorship: Yes
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: 1st - Day
Valid Driving License: No
Hazardous Material(s): No
Required Skills: Drug Metabolism, Pharmacokinetic Modeling, Pharmacokinetics, Phoenix WinNonlin, Toxicokinetics
Preferred Skills: Job Posting End Date: 07/31/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R349426
Job Tags
For contractors, Work at office, Local area, Remote work, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,