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    Senior Pharmacokinetic Scientist

    Praxis
    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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