Director, Quantitative Clinical Pharmacology Lead

Role Summary

Director, Quantitative Clinical Pharmacology (QCP) Lead in Cambridge, MA. Leads strategic, scientific, and operational aspects of multiple drug development projects with independence, driving dosage selection and causality evidence within the QCP team.

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. Has 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 and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
• Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data and Quantitative Sciences (DQS) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.

Accountabilities

• 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.
• Drafts and executes 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 DQS and external partners.
• Maintains a high standard for good clinical practice, compliance, and ethics.
• Mentors junior staff to promote scientific excellence and individual achievement.
• Participates as a member of Business Development due diligence, when requested.
• Contributes to infrastructure initiatives and/or cross-functional best practice initiatives.
• Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline.

Education, Behavioral Competencies and Skills

Education & Experience

• 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.
• Preference given to candidates with experience in oncology drug development.

Technical skills

• Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies.
• Formulates and executes clinical pharmacology plans including integration of MIDD principles.
• Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in cross-functional interfaces with Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs.
• Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across different regions (ICH, FDA, EMA and others).
• Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making.
• Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics.
• Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy.

Behavioral competencies

• Independently works by delivering, and prioritizing QCP activities across projects with minimal supervision.
• Effectively drives and influences project teams towards objectives while enabling and making decisions.
• Focuses on priorities and delivers on commitments.
• Strong communication skills and ability to translate effectively across functional lines.
• Collaborative mindset, inspires teamwork, and is effective at building alliances across functions.
• Assess benefit/risk of options.
• Develop understanding of business beyond QCP/Pharmacometrics.