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.
• Lead development of scientific strategy across therapeutic areas with a focus on mechanistic platforms/biomarkers to aid translation, measurement of target engagement, and dose regimen predictions.
• Work collaboratively with multidisciplinary teams to design and prosecute studies in line with project strategy.
• Present research results to scientific teams, management, and regulatory agencies.
• Write sections of regulatory submissions, respond to regulatory inquiries, and maintain knowledge of regulatory guidance.

REQUIRED EDUCATION AND EXPERIENCE:

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

BENEFITS/COMPENSATION:

• US base salary range: $114,000–$185,000.
• Eligible for short-term and long-term incentives.
• Comprehensive benefits including healthcare/insurance starting day one, 401K match and profit-sharing, and 4 weeks of vacation.