Senior Director, Quantitative and Clinical Pharmacology
GlobeNewswire
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Florida • Maryland • United States
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Salary
💰 $222,400 - $278,000 per year
Job Level
About the role
- Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
- Represent as therapeutic lead (siRNA or oligonucleotide experience is preferred) and SME in clinical pharmacology strategies, clinical study protocol preparation, study execution, data review/analysis, and study reports
- Lead the development and execution of translational and mechanistically based PK/PD modeling to enable identification of FIH dose, early characterization of efficacy and safety using biomarkers and disease animal models
- Lead and execute pharmacometrics strategies across all stages of drug development including population PK, PK/PD modeling and simulations, meta-analysis, disease modeling to inform clinical development
- Support non-clinical PK/PD, ADME and DMPK evaluations including strategy development, study design and execution, data analyses to inform lead optimization, candidate selection and nonclinical drug development
- Represent as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience is a must)
- Supervise, mentor and develop a team of high-performing scientists
- Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications
- Encompass leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publish manuscripts
- Advocate scientific leadership at external conferences and scientific community.
Requirements
- PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or related field with ≥ 10 years of experience working in biotech or pharmaceutical industry
- Expertise in clinical pharmacology and pharmacometrics principles, strong hands-on experience in modeling and data analytics, and proven success in regulatory interactions from IND through registration
- siRNA and/or Oligonucleotide experience is highly preferred
- Demonstrated success in leading and building high-performing teams, with a strong commitment to people development
- Excellent communication, multitasking, and collaboration skills in cross-functional and matrixed team environments
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical pharmacologypharmacometricsPK/PD modelingdata analyticspopulation PKmeta-analysisADMEDMPKregulatory interactionsdrug development
Soft Skills
leadershipmentoringteam developmentcommunicationmultitaskingcollaboration
Certifications
PhD in Clinical PharmacologyPhD in PharmacometricsPhD in Pharmaceutical Sciences