Associate Director, Quantitative Pharmacology, Clinical Pharmacology

Provide clinical pharmacology input into all phases of both small and large molecule drug development across multiple therapeutic areas, including CNS, Nephrology, Infectious Disease, and Immunology.

Responsibilities

• Support all clinical pharmacology activities related to pre-IND, IND, Phase 1-3, PK, PK/PD, and regulatory submissions.
• Support study design, execution, and reporting of clinical studies.
• Collaborate with multi-functional project teams and interact with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance, and drug interaction studies.
• Author the clinical pharmacology section in submission documents and represent the department at product development team meetings.
• Participate in the planning of pharmacometrics strategies and provide input on modeling and simulation activities.
• Interact with early development and business development teams as well as external collaborators to assess and lead development and selection of pre-IND and early phase assets.
• Serve as clinical pharmacology lead on cross-functional project teams and support model-based drug development strategies.
• Conduct translational or clinical PK and PK/PD data plotting and analysis, including noncompartmental analysis (NCA), correlation analysis, exposure-response analysis, and meta-analysis.
• Work closely with the pharmacometrics team and provide input related to analysis and reporting of PK, PK/PD, and exposure-response.
• Author clinical pharmacology sections in regulatory documents for filings including annual reports, investigator’s brochures, IND/NDA applications, and pediatric development plans; author scientific manuscripts or other publications.
• Collaborate with bioanalytical team members on assay development, sample management, pharmacogenomics, and biomarker development.
• Work with formulation development groups to support activities related to formulation development, dissolution testing, in vivo-in vitro correlations (IVIVC), in vivo PK studies, and biowaivers for pre- and post-approval formulations.
• Manage clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, statement of work (SOW), and approval of invoices.

Requirements

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
• Hands-on experience 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.
• Strong working knowledge of formulation development, drug development, and clinical development.
• Current awareness of the latest developments in clinical pharmacology, pharmacometrics, and guidance documents.
• Ability to apply scientific knowledge to drug development, anticipate and identify core problems, and solve problems effectively.
• Strong organization skills and flexibility to react rapidly to changing situations/environments.
• Strong communication (verbal and writing) skills.
• 15% travel required.

Qualifications

PhD, PharmD, or MS in Clinical Pharmacology (or a related 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 is a plus.

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Additional company-provided benefits.

Pay

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals hired in the role to perform in the United States. Other elements may be used to determine actual pay, such as job experience, specific skills, and comparison to internal incumbents currently in the role.