Associate Principal Scientist, Toxicokinetics
Associate Principal Scientist, Toxicokinetics
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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:
Masters (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
#EligibleforERP
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US and Puerto Rico Residents Only:
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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 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$156500.00 - $246300.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
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
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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:
RegularRelocation:
Domestic/InternationalVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
NoRequired Skills:
Assay Development Bioanalytical Techniques Business Cell-Based Assays Communication Detail-Oriented DMPK Drug Metabolism Flow Cytometry Immunoassays Innovation Liquid Chromatography-Mass Spectrometry (LC-MS) Mentorship Pharmacokinetics PKPD Modeling Project Leadership Social Collaboration Strategic ThinkingPreferred Skills:
Job Posting End Date:
06/30/2025*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.
Required Experience:
Staff IC
Employment Type
Full-Time
