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Pharmacokinetics (PK) Scientist
Irvine, CA, US
Scientific
Bachelors Degree
Full Time, Temporary
$40-$65/hour
Experienced (Non-Manager)
Remote
Medical Devices and Supplies
First Shift (Day)
Irvine, CA, US
$40-$65/hour
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
Remote
Scientific
Bachelors Degree
First Shift (Day)
Job details
Research Scientist, Pharmacokinetics
Kelly® Science & Clinical is seeking a Research Scientist, Pharmacokinetics for a temporary/contract opportunity supporting an ocular product portfolio within Pharma and Consumer Eye Care.
Employment Type: Full-time, temporary/contract
Duration: Approximately 6 months, with potential for extension
Location: Remote
Position Overview
The Research Scientist, Pharmacokinetics will provide hands-on pharmacokinetic (PK) support to project representatives across an ocular product portfolio. This role will execute the day-to-day analytical, study-monitoring, literature research, and scientific documentation activities necessary to keep preclinical and clinical PK programs moving forward.
The ideal candidate will bring a strong foundation in pharmacokinetic principles, hands-on experience with noncompartmental analysis (NCA), excellent scientific writing skills, and the ability to effectively manage multiple projects and priorities.
Key Responsibilities
- Perform noncompartmental pharmacokinetic (PK) and/or toxicokinetic (TK) analyses on preclinical and clinical datasets, including ocular and systemic tissue data.
- Generate PK parameter tables, concentration-time profiles, summary statistics, and other analytical outputs.
- Interpret and summarize PK/TK findings for review by project representatives.
- Assemble, reconcile, and perform quality control of PK datasets prior to analysis.
- Verify sample accountability, below-limit-of-quantification (BLQ) handling conventions, units, and other critical data elements.
- Monitor ongoing studies conducted at Contract Research Organizations (CROs) and internal laboratories, identifying and escalating study deviations, data anomalies, and other issues to the responsible project representative.
- Conduct scientific literature searches related to ocular pharmacokinetics, ADME, and competitor products.
- Synthesize published literature into concise, decision-ready summaries and data packages.
- Draft, format, and revise PK study reports, report sections, and PK-related protocol language.
- Route scientific documentation for peer, data-integrity, and managerial review and incorporate reviewer comments.
- Provide additional scientific and operational support as project needs and priorities evolve.
Scope of the Position
This is an individual-contributor role supporting multiple project representatives and concurrent programs. The Research Scientist will work under the direction of a senior PK scientist, using established methods with guidance provided for scientific interpretation.
The position will also interact with external contract laboratories and CRO partners under appropriate supervision.
Direct Reports: None
Key Relationships
Internal Partners: PK project representatives, Bioanalytical, Pharmaceutical Development, and other cross-functional scientific partners.
External Partners: Bioanalytical and PK CROs, study directors, and contract laboratories.
Qualifications
Education & Experience
- BS/BA in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, Chemistry, Biology, or a related scientific discipline with a minimum of 3 years of relevant experience, OR
- MS in a related scientific discipline with a minimum of 2 years of relevant experience.
- PhD candidates are welcome to apply; a PhD is not required for this position.
- Prior ophthalmic or topical-route experience is a plus but is not required.
Technical Skills
- Working knowledge of pharmacokinetic principles and noncompartmental analysis (NCA).
- Hands-on experience with Phoenix WinNonlin or comparable pharmacokinetic analysis software strongly preferred.
- Proficiency with Microsoft Excel and scientific data handling.
- Ability to assemble, reconcile, review, and quality-check scientific datasets.
- Demonstrated scientific and technical writing ability, including preparation of study reports or comparable formal scientific documentation.
- Experience conducting scientific literature searches using PubMed, Google Scholar, or similar databases.
- Experience working with preclinical and/or clinical PK datasets preferred.
- Experience interacting with CROs or contract laboratories is beneficial.
Key Competencies
- Ability to effectively multitask across multiple programs and shifting priorities.
- Proactive, can-do approach and willingness to step in wherever the team needs support.
- Strong written and verbal communication skills.
- Excellent attention to detail and commitment to data quality.
- Strong organizational and follow-through skills.
- Ability to collaborate effectively with internal scientific teams and external CRO partners.
- Comfortable working in a fast-paced, matrixed scientific environment.
Compensation
Pay rate will be determined based on the candidate’s education, directly relevant pharmacokinetics and CRO-related experience, and geographic location.
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