Senior Pharmacokinetic Scientist

5+ years

Not Disclosed

Remote - Europe

10 July 22, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Pharmacokinetic Scientist
Reports to: Director, Clinical Pharmacology
Location: Remote (with travel to Boston area as needed)
Salary Range: $145,000 - $154,000 per year

Position Summary:

We are seeking an experienced Senior Pharmacokinetic Scientist to join our Clinical Pharmacology department. This role involves providing senior-level quantitative PK support across Praxis Drug Development teams. Responsibilities include hands-on and validation support for pharmacokinetic (PK) non-compartmental (NCA) data analyses and population PK/pharmacodynamic (PD) analyses. The role also supports clinical trial reporting, compound development plans, and regulatory submissions while offering strategic direction for PK/PD data analysis and modeling.

Primary Responsibilities:

PK Data Analysis: Conduct or validate PK data analysis using NCA, including reviewing source data for relevance and accuracy.
Data Interpretation: Provide accurate interpretation of study results related to PK and/or PD endpoints.
Modeling & Simulation: Guide and liaise with external vendors for modeling, simulation, and disease modeling; generate predictive simulations with nonclinical and clinical data.
Protocol Development: Contribute to trial protocol development and write or review Statistical Analysis Plans, including PK or PK/PD analysis components.
Documentation: Author and/or review PK/PD components of internal and external publications, presentations, and regulatory documents, including INDs, NDAs, ANDAs, and BLAs.
Regulatory Support: Collaborate with regulatory affairs to provide PK/PD data for regulatory communications and presentations.
Mentorship: Provide mentorship and PK software training as required.
Project Collaboration: Actively participate in cross-functional project teams as a clinical pharmacology representative.

Qualifications and Key Success Factors:

Education: Advanced degree (Ph.D. preferred) or M.Sc. in Clinical Pharmacology, Biopharmaceutics, or related fields.
Experience: Minimum of 5 years of experience as a PK scientist in pharmaceutical clinical trials.
Knowledge: In-depth understanding of PK/PD principles, ADME concepts, and regulatory requirements related to clinical pharmacology and drug development.
Skills: Expertise in pharmacometrics and computational skills, with hands-on experience using PK and M&S software (e.g., Phoenix WinNonlin/NLME, NONMEM, R, S-Plus, SimCYP).
Communication: Excellent scientific writing and data interpretation skills, with the ability to communicate complex data effectively.
Project Management: Ability to prioritize and manage multiple projects with competing timelines, demonstrating logical thinking, creativity, and independence.

Compensation & Benefits:

Praxis offers a comprehensive benefits package including:

99% premium coverage for medical, dental, and vision plans (Blue Cross Blue Shield)
Quarterly bonus program
401k plan with 100% match up to 6% of employee contributions (Traditional & Roth)
$200/month wellness benefit for flexible options
Unlimited PTO, two weeklong shutdowns each year, and extended family leave
Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

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Senior Pharmacokinetic Scientist

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