PK/PD Principal Scientist

POSITION RESPONSIBILITIES

• Independently design and analyze in vivo PK/PD, PK and TK studies in multiple veterinary species, including writing study protocols and reports.
• Provide PK and PK/PD modeling and simulation to help select lead candidates and optimize dose regimens.
• Collaborate with bioanalytical team to assess suitability of analytical assays and forecast analytical requirements for projects.
• Lead development of scientific strategy across therapeutic areas with a focus on mechanistic platforms/biomarkers to aid in translation, measurement of target engagement, and dose regimen predictions.
• Present research results to scientific teams, management, and regulatory agencies.
• Write sections of regulatory submissions, respond to inquiries from regulatory agencies, and maintain knowledge of regulatory guidance documents.

REQUIRED EDUCATION AND EXPERIENCE

• Ph.D in pharmacology, biochemistry, or related field with 4 or more years of relevant pharmaceutical development experience.
• DVM DACVCP or DVM Dipl. ECVPT is highly desirable.
• Proven ability to design, analyze and interpret in vivo PK and PK/PD studies.
• Experience with biotherapeutics (protein therapeutics) is highly desirable.
• Skilled in the use of PK and PK/PD analysis software such as WinNonlin, Monolix or Watson.
• Excellent verbal & written communication skills.
• Self-starter, able to prioritize work and work efficiently with minimal supervision.
• Working knowledge of bioanalytical methodology.
• Knowledge of ADA assays and assessment of immunogenicity of biotherapeutics is highly desirable.
• Experience in PK/PD modeling and simulation such as PBPK, QSP or population PK modeling using NONMEM, R, or related software is highly desirable.
• Experience interacting with regulatory agencies is highly desirable.
• Experience conducting GLP studies is desirable.

PAY

The US base salary range for this full-time position is $114,000 - $185,000.