Associate Director, Quantitative Pharmacology, Clinical Pharmacology

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer clinical pharmacology expertise throughout all stages of small- and large-molecule drug development across various therapeutic areas.

• Assist with clinical pharmacology tasks related to pre-IND, IND, Phase 1–3, pharmacokinetics (PK), pharmacokinetics/pharmacodynamics (PK/PD), and regulatory submissions.

• Aid in the design of clinical studies, development of protocols, execution of studies, reporting, and interpretation of data.

• Act as the clinical pharmacology leader on cross-functional project teams.

• Support strategies for model-based drug development.

• Perform translational or clinical PK and PK/PD data plotting and analysis, including non-compartmental analysis (NCA), correlation, exposure-response, and meta-analysis.

• Collaborate with pharmacometrics teams on PK, PK/PD, and exposure-response analysis and reporting.

• Write clinical pharmacology sections for regulatory documents, including annual reports, investigator brochures, IND/NDA applications, and pediatric development plans.

• Prepare scientific manuscripts and other publications.

• Work in partnership with non-clinical, bioanalytical, formulation development, early development, business development, and external collaborator teams.

• Assist with assay development, sample management, pharmacogenomics, and biomarker development.

• Contribute to formulation development, dissolution testing, in vitro-in vivo correlation (IVIVC), in vivo PK studies, and biowaivers.

• Oversee project budgets, outsourced PK and PK/PD analyses, contract requisitions, statements of work, and approval of invoices.

• Engage in pharmacometrics strategy planning and modeling and simulation activities.

• Evaluate and lead the development and selection of pre-IND and early-phase assets.

⛳️ Requirements

• Comprehensive understanding of clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), drug metabolism, biopharmaceutics, and bioanalytical chemistry.

• Practical experience in PK and PK/PD analysis utilizing software such as Phoenix NLME and R.

• Strong knowledge of Phase I clinical operations, drug development processes, multi-region regulatory requirements, and PK/PD analysis.

• Proficient understanding of formulation development, drug development, and clinical development.

• Up-to-date knowledge of advancements in clinical pharmacology, pharmacometrics, and relevant guidance documents.

• Capability to apply scientific expertise in drug development, pinpoint fundamental issues, conduct insightful analyses, and resolve problems efficiently.

• Extensive hands-on clinical pharmacology experience.

• Excellent organizational abilities.

• Strong verbal and written communication skills.

• Adaptability to swiftly respond to changing situations and environments.

• PhD, PharmD, or MS in Clinical Pharmacology or related fields such as Biomedicine, Pharmacokinetics, Pharmacometrics, Clinical Pharmacology, or Pharmaceutics.

• At least 4 years of industry experience in the relevant areas.

• Experience in population PK and PK/PD modeling and statistical models is advantageous.

• Willingness to travel up to 15% of the time.

🏝️ Benefits

• Opportunity for incentives.

• Comprehensive coverage for medical, dental, vision, and prescription drugs.

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement programs.

• Assistance with student loans.

• Generous 401(k) matching.

• Flexible time off policy.

• Paid holidays.

• Paid leave programs.

• Additional benefits provided by the company.