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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical pharmacology and modeling, with a strong focus on drug development strategies, regulatory compliance, and advanced pharmacometric methodologies. Proficient in designing and interpreting clinical studies while collaborating effectively with multidisciplinary teams.
Highest-signal resume keywords
Clinical Pharmacology ExpertisePharmacokinetic ModelingFDA Guidelines ApplicationNONMEM UtilizationOncology Drug Development Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Protocol WritingPharmacodynamic ModelingMathematical Disease ModelingMeta-Analysis ConductingSimulation Methodologies
Soft Skills
CollaborationPresentation SkillsCommunication
Tools & Technologies
NONMEMMonolixR
Industry Keywords
Pharmaceutical SciencesClinical DevelopmentICH GuidelinesOncologyDrug Development Strategy
About the role
Key responsibilities & impact- Contribute to multidisciplinary teams designing efficient clinical development programs and robust registration packages
- Predict human dose ranges, characterize exposure-response relationships, and justify dose recommendations for later studies and special populations
- Design and interpret clinical pharmacology studies evaluating intrinsic and extrinsic effects on pharmacokinetics and pharmacodynamics
- Develop mathematical disease, disease-progression, pharmacodynamic and pharmacokinetic models
- Conduct meta-analyses and simulations to assess trial design performance
- Present CPMS strategies and model-based outcomes to project teams, governance boards and regulatory agencies
- Write clinical trial protocols, reports, clinical investigator brochures and regulatory submission package sections
- Apply FDA and ICH guidelines to clinical study design and drug development strategy
- Advocate for model-informed drug discovery and development through collaboration, publications and conference presentations
- Collaborate with development team leaders, statisticians, biologists, physicians and drug metabolism scientists
- Learn and apply emerging modelling and simulation methodologies and collaborate with external methodology experts
Requirements
What you’ll need- Advanced training with a PhD or MD in Pharmaceutical Sciences, (Bio)Engineering, Statistics, Medicine or related field; a PharmD or Master’s degree in the same disciplines with an additional 4 years of relevant experience may be considered
- 5+ years’ experience leveraging clinical pharmacology and modeling in drug development
- 5+ years’ experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models
- 5+ years of experience utilizing tools for quantitative clinical pharmacology such as NONMEM, Monolix, or R
- Experience applying appropriate FDA and ICH guidelines in the design of clinical development plans and studies
- Oncology drug development experience preferred
- Experience with advanced pharmacometric approaches such as tumor size kinetics, joint models, model-based meta-analysis, adaptive dosing simulations, and/or mechanistic PKPD modeling preferred
- Experience designing, analyzing and reporting clinical studies with a simulation- or modelling-based approach preferred
- Familiarity with M&S contributions to regulatory interaction and submission documents preferred
- Knowledge or ability to quickly learn oncology disease mechanisms, endpoints, progression and treatments preferred
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in share-based long-term incentive program
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
- Comprehensive US employee benefits program