PK/PD Principal Scientist

Scorpion Therapeutics; Michigan; On-site; USD 114,000 - 185,000; Full time

Benefits offered by this job

Healthcare starting day one

401K match and profit-sharing

4 weeks vacation

Incentive programs

Job summary

Scorpion Therapeutics is seeking a senior PK/PD scientist to independently design and analyze in vivo PK/PD studies across species, providing modeling to optimize dosing and select leads. You will collaborate with bioanalytical teams and contribute to strategy across therapeutic areas with biomarkers and target engagement analysis.

You will present findings to cross-functional teams and support regulatory submissions, leveraging experience with PK/PD modeling, PBPK, and GLP contexts.

Qualifications

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

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.

Skills

PK/PD modeling

Verbal communication

Written communication

Education

Ph.D in pharmacology/biochemistry

DVM DACVCP or DVM Dipl. ECVPT (desirable)

Tools

WinNonlin

Monolix

NONMEM/R

Watson

Job description

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.