Senior Director, Quantitative Pharmacology

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

📋 Description

• Supervise clinical pharmacology activities and deliverables at all phases of clinical development.

• Assist the Head of Quantitative Pharmacology in managing and expanding the functional team.

• Mentor and train junior scientists, fostering the growth of clinical pharmacology talent.

• Manage pre-IND, IND, Phase 1–3, PK, PK/PD, and regulatory submission deliverables.

• Review and endorse Clinical Pharmacology reports and analyses.

• Direct clinical pharmacology strategy, including dose finding, dose optimization, exposure-response, and pediatric development.

• Act as the Clinical Pharmacology Lead on both early- and late-stage development teams.

• Develop data-driven plans and communicate findings and strategies to development teams.

• Coordinate clinical pharmacology interactions with toxicology, DMPK, bioanalytical, biomarker, pharmacometrics, statistics, clinical, regulatory, ADME, and CMC functions.

• Evaluate business development opportunities and provide go/no-go recommendations for QTR.

• Assist in defining departmental strategy, growth, and cross-functional alignment.

• Direct clinical pharmacology strategy and integrate it into clinical development plans for both small- and large-molecule drugs.

• Lead the development and approval of clinical pharmacology sections for regulatory submissions.

• Support MIDD strategies and PK/PK/PD modeling analyses for dose selection as well as efficacy and safety evaluations.

• Aid in biomarker development and its integration into early-phase studies.

• Employ innovative data analysis techniques to optimize doses, dosage regimens, and study designs.

• Review and approve clinical study designs and protocols for healthy subjects.

• Collaborate with formulation, biomarker, and bioanalytical teams on formulation development, assay development, sample management, PGx, and biomarker strategy.

⛳️ Requirements

• PhD in Clinical Pharmacology or a related field such as pharmacokinetics, pharmacology, or pharmaceutics.

• At least 12 years of experience in relevant fields.

• Extensive experience in developing and executing clinical pharmacology strategies for early- to late-stage programs, including support for registrational processes.

• Profound knowledge of early-phase study design, PK, PD, drug metabolism, biopharmaceutics, biomarkers, and bioanalytical assays for small molecules and monoclonal antibodies.

• Practical experience in PK and PK/PD data analysis and Phoenix NLME.

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

• Solid understanding of formulation development and clinical development.

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

• Capability to apply scientific knowledge to identify fundamental issues, conduct insightful analyses, and resolve problems effectively.

• Proven leadership experience in clinical pharmacology.

• Excellent organizational skills.

• Strong communication abilities.

• Adaptability to respond quickly to changing situations and environments.

• Willingness to travel up to 20%.

• Experience in developing early-phase clinical protocols is an advantage.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Opportunity for incentives.