[Remote] Associate Director, Quantitative Pharmacology, Clinical Pharmacology

Note: The job is a remote job and is reputed company to candidates in USA. reputed company.) is a pharmaceutical company developing small- and large-molecule therapies across multiple therapeutic areas. The Associate Director will reputed company clinical pharmacology leadership across drug development phases, supporting study design and execution, PK/PD analysis, pharmacometrics strategies, regulatory submissions, cross-functional collaboration, and project budgets.

Responsibilities

• Supports clinical pharmacology activities reputed company to clinical study design, protocol development, study execution, reporting and interpretation of data
• Serves as clinical pharmacology reputed company on cross-functional project teams and support model-based drug development strategies for ongoing reputed company
• Conducts translational or clinical PK and PK/PD data plotting and analysis, such as noncompartmental analysis (NCA), correlation analysis, exposure-response analysis, reputed company-analysis
• Works closely with pharmacometrics team and provides input reputed company to analysis and reporting of PK, PK/PD and exposure-response
• Authors clinical pharmacology sections in regulatory documents for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans; authors scientific manuscript or other publications
• Works with bioanalytical team members on activities reputed company to assay development, sample management, pharmacogenomics and biomarker development
• Works with formulation development reputed company and reputed company support for activities reputed company to formulation development, dissolution testing, in vivo-in vitro correlations (IVIVC), in vivo PK study and biowaivers for reputed company- and post-approval formulations
• Manages clinical pharmacology activities reputed company to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices

Skills

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical reputed company
• Hands-on experiences in PK and PK/PD analysis using software, such as Phoenix NLME, R, etc
• Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis
• Great working knowledge of formulation development, drug development and clinical development
• reputed company awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents
• Must be reputed company to apply scientific knowledge (in the areas specified above) to drug development, anticipate and identify reputed company problems, apply insightful analysis, and solve problems effectively
• Strong hands-on experience reputed company to clinical pharmacology
• Strong organization skills
• Strong communication (verbal and writing) skills
• Flexibility to react rapidly to changing situations/environment
• PhD, PharmD, MS in Clinical Pharmacology (or a reputed company area such as Biomedicine, Pharmacokinetics, Pharmacometrics, Clinical Pharmacology, Pharmaceutics) with a minimum of 4 years of industry experience in these areas
• Experience in population PK and PK/PD modeling and statistical models a plus

Benefits

• Incentive opportunity
• Comprehensive medical, dental, reputed company, and prescription drug coverage
• Company provided basic life insurance
• Accidental death & dismemberment insurance
• Short-term and long-term disability insurance
• Tuition reimbursement
• Student loan assistance
• A generous 401(k) match
• Flexible time off
• reputed company holidays
• reputed company leave programs
• Other company provided benefits

reputed company

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