Director, Clinical Pharmacology

Job Title: Clinical Pharmacology LeadRemote rolePrimary ResponsibilitiesClinical Pharmacology Strategy: Lead CP strategy across early and late-stage development, integrating PK, PD, exposure–response, and biomarker data to guide dose selection, regimen, and overall study design.Model-Informed Drug Development (MIDD): Own MIDD plans (e.g., population PK, PBPK, quantitative systems approaches) to optimize trial designs and key decision points from first-in-human through pivotal phases.Regulatory Documentation: Author and review CP deliverables for protocols, clinical development plans, Investigator’s Brochures (IBs), Statistical Analysis Plans (SAPs), and regulatory submissions (IND/IMPD/NDA/BLA/MAA), ensuring clarity, traceability, and compliance.Data Analysis & Reporting: Drive analysis and reporting of PK/PD and exposure–response results (both internal and CRO-executed), ensuring scientific integrity, reproducibility, and timely insights for program teams and governance.Bioanalytical Strategy: Establish and oversee bioanalytical strategies, including method selection/validation, sample handling, and data quality control, in partnership with Translational Medicine and external labs/CROs.Health Authority Interactions: Lead interactions with regulatory authorities for CP topics; prepare briefing materials, address Information Requests (IRs), and represent the function in meetings with FDA, EMA, and other agencies.Cross-Functional Leadership: Collaborate with Clinical, Biostatistics, Data Science, CMC, and Regulatory teams to integrate quantitative evidence into go/no-go decisions and portfolio prioritization.Vendor Management: Select and manage CP-related CROs; define scopes, oversee execution, and ensure deliverables meet quality and timeline expectations.Standards & Governance: Advance standards (CDISC/ADaM for PK datasets, data pipelines, reproducibility) and champion inspection readiness in a GxP environment.QualificationsEducation:PhD or PharmD (or MS with significant industry experience) in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related quantitative field.Experience:Minimum 5+ years in biotech/pharma Clinical Pharmacology, with end-to-end ownership of CP strategy, MIDD, and regulatory submissions across Phase 1–3.Additional years of experience in leadership or complex program management preferred.Technical Expertise:Population PK/PD modeling (NONMEM, Monolix), PBPK (Simcyp, GastroPlus), and exposure–response methods.Oversight of bioanalytical method development/validation and data integrity in GxP contexts.Authoring high-quality CP sections for protocols, IBs, and regulatory dossiers; direct participation in FDA/EMA meetings.Soft Skills:Strong independent contributor with exceptional scientific communication and cross-functional influence.Proven decision-making skills in fast-paced environments.Vendor management and collaborative leadership experience.LI-CA-CPHARM-remote