Director, Quantitative Clinical Pharmacology Lead

Role Summary

Director, Quantitative Clinical Pharmacology Lead based in Cambridge, MA. You will drive the clinical pharmacology strategy from pre-FIH through life-cycle management, partnering with the pharmacometrics lead to advance a model-informed drug development path. You will lead scientific and operational aspects of multiple drug development projects, mentor junior staff, and represent Clinical Pharmacology within regulatory interactions and external scientific communities.

Responsibilities

• Leads strategic, scientific, and operational aspects of multiple drug development projects with high independence from first-in-human dosing through lifecycle management, including primary responsibility for dosage selection and generation of causality evidence.
• Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure, and best-practice initiatives.
• Explores synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other data science disciplines.
• Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data and Quantitative Sciences (DQS) to the R&D organization and external scientific community via high-value participation at scientific meetings and publications.
• Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and sub-teams.
• Drafts and executes clinical pharmacology plans, including integration of M&S, in collaboration with partner functions (e.g., pharmacometrics, statistics, DMPK).
• Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches to inform internal decisions and regulatory interactions.
• Represents Clinical Pharmacology in meetings with regulatory agencies and prepares clinical pharmacology summary documents for regulatory submissions.
• Oversees and/or performs PK, PD, and pharmacometric analyses with DQS and external partners; interprets PK/PD data.
• Maintains high standards for good clinical practice, compliance, and ethics.
• Mentors junior staff to promote scientific excellence and achievement.
• Participates in Business Development due diligence when requested and contributes to infrastructure and cross-functional initiatives.
• Demonstates leadership in scientific societies and cross-industry consortiums related to clinical pharmacology.

Qualifications

• Education & Experience: Pharm D. or PhD with 8+ years of experience in a quantitative field with exposure to clinical pharmacology/PK-PD; or MS with 12+ years of experience in a quantitative field with exposure to clinical pharmacology/PK-PD. Preference given to oncology drug development.

Skills

• Advanced knowledge of clinical pharmacology in early, late, and post-marketing studies; ability to formulate and execute clinical pharmacology plans with MIDD principles.
• Expertise in cross-functional interfaces with Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, and Global Regulatory Affairs.
• Strong understanding of regulatory guidance for design, analysis, and regulatory submissions across regions (ICH, FDA, EMA, others).
• Experience integrating PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making.
• Subject matter expertise in several clinical pharmacology areas; capability to translate scientific concepts across functions.
• Scientific understanding of biological translation and its integration into pharmacology/pharmacometrics strategy.
• Effective communication across functional lines; collaborative mindset and ability to build alliances.
• Ability to independently prioritize QCP activities across projects and drive decisions.

Education

• Pharm D. or PhD with 8+ years of quantitative experience; or MS with 12+ years of quantitative experience, with exposure to clinical pharmacology/PK-PD. Oncology experience preferred.