Director, Quantitative Clinical Pharmacology (QCP) Lead

Role Summary

Director, Quantitative Clinical Pharmacology (QCP) Lead

Responsibilities

• Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Drives the integration of biological, pharmacological, and clinical insights and possesses primary responsibility for dosage selection and generation of causality evidence across the drug development continuum.
• Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.
• Explores and excels in synergistic relationships with experts in translational sciences, digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
• Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.
• Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams.
• Collaborates cross-functionally with discovery, toxicology, and other QPTS functions to ensure that preclinical findings are effectively translated into clinical biomarker plans and exploratory endpoints.
• Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).
• Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions.
• Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and is responsible for clinical pharmacology summary documents for regulatory submissions.
• Oversees and/or independently performs PK, PD, and pharmacometric analyses, including the interpretation of PK/PD data in close partnership with DSI and external partners.
• Maintains a high standard for good clinical practice, compliance, and ethics.
• Provides mentorship to junior staff, acts as a cross-functional leader and may manage a sub-team within a TA.
• Participates as a member of Business Development due diligence, when requested.
• Leads infrastructure initiatives and/ or cross-functional best practice initiatives.
• Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline, such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA.

Qualifications

• Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD
• MS with 12+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD

Skills

• Extensive knowledge and experience with design, analysis, and reporting of clinical pharmacology studies.
• Specialized clinical pharmacology expertise in multiple therapeutic areas, development phases, and/or different regions.
• Experience with translational studies, disease-relevant models, and biomarker plans to support clinical translation and early clinical development strategy.
• Experience in leading and driving the scoping and implementation of MIDD within projects.
• Hands-on expertise/knowledge in application of advanced knowledge in integration of multiple data sources (PK/PD/Efficacy/Safety/biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial design, and quantitative decision making.
• Experience in regulatory submission and approvals of at least one original/major NDA/CTDs or multiple supplemental NDA/CTDs (global or regional).
• Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant development milestones such as EoP2, pre-submission, and pediatric development plan (PIP and PWR).
• Strong knowledge of allied fields critical for drug development, such as statistics, drug metabolism, pharmacology, toxicology, bioanalysis, and pharmaceutical science.
• Ability to evaluate Benefit-Risk associated with project decisions, effectively manage GPT expectations, and influence TA strategies.
• Leadership in cross functional decision to optimize the likelihood of drug R&D success and utilization of the quantitative decision-making framework.
• Drives for efficiency using innovative processes and methodologies.
• Accelerates regional development and filings through innovation (regional QCP).

Additional Requirements

• Independently executes QCP deliverables and provides solutions to complex issues.
• Communicates effectively and influences in cross-functional teams.