Executive Director, Head of Clinical Pharmacology and Pharmacometrics

The Role:

Moderna is seeking an innovative, highly collaborative, strategic, and highly people focused Head of Clinical Pharmacology and Pharmacometrics to lead and continue to elevate our talented Clinical Pharmacology and Pharmacometrics team and capabilities to meet the growing needs of the business.  This is an important leadership role for Moderna which requires outstanding thought leadership and influence in pharmacology and people leadership skills. The position is positioned within the new Translational Medicine function within our growing Therapeutics & Oncology development organization in R&D at Moderna and will provide industry leading leadership to clinical pharmacology and pharmacometrics across the enterprise from pre-clinical through lifecycle management of programs. 

The ideal candidate will be an externally recognized and well respected expert in Clinical Pharmacology, population PK, pharmacometrics, and/or DMPK and have extensive experience applying innovative pharmacology approaches to IND filings, first in human dose prediction, drug development, dose recommendations for clinical studies, study design, dose decisions and health authority interactions.

This is a highly visible role that is expected to partner effectively with key stakeholders in research and development across the enterprise and represent an expert clinical pharmacology perspective on Moderna’s internal governance committees.  This leader will also contribute innovative thinking in pharmacology to advance our mRNA platform with excellence.

This leader is expected to build a high performing clinical pharmacology and pharmacometrics team as a partner to advance the innovative discovery and development of Moderna’s mRNA vaccine and therapeutics platform to patients.  This leader will have significant people leader experience and will know how to earn the trust and respect of their team members, colleagues and senior leaders across company by communicating authentically and with conviction as well as to embrace Moderna’s leadership mindsets.  

Here’s What You’ll Do:

• Work vertically and horizontally across Research and Development to ensure robust, innovative, and consistent clinical pharmacology and pharmacometrics strategies across the pipeline from pre-IND through early and late development and lifecycle management

• Ensures consistent and innovative data interpretation and pharmacology recommendations on dose prediction, PK-PD modeling, exposure response, population PK, drug-drug interactions (DDI), pharmacology in special populations, and quantitative pharmacology activities to inform the mechanistic understanding of novel drug candidates, and support optimal dose and dose schedule decisions across the pipeline

• Ensures effective partnering of the clinical pharmacology and pharmacometrics team with research on the design, data analysis, and interpretation of pharmacokinetic, toxicokinetic and pharmacodynamics (PD) aspects of preclinical studies to support INDs and rigorous FIH dose prediction

• Develop, build and mentor a high performing clinical pharmacology and pharmacometrics team 

• Ensures consistent, state of the art clinical pharmacology input in regulatory documents (INDs, clinical study protocols, pharmacology study reports, health authority filings and responses to health authority questions).

• Represent the expert clinical pharmacology perspective as needed in health authority meetings

• Represent an expert clinical pharmacology perspective on Moderna’s internal governance committees to ensure robust and data driven go/no go, and dose decisions for programs

• Drive innovative pharmacology approaches to advance our mRNA platform

• Partner with internal and external subject matter experts to inform all major go/no-go development decision criteria to advance programs

• As a member of the translational medicine leadership team, shape the future of the translational medicine organization at Moderna

Here’s What You’ll Bring to the Table:

• PhD in Clinical Pharmacology, Pharmacometrics, or related discipline

• Development background in oncology, rare diseases, infectious diseases and/or mRNA therapeutics

• A minimum of 10 years of related pharmaceutical or biotechnology industry experience in clinical pharmacology, population PK, PK-PD modeling, DMPK, and/or pharmacometrics and a proven track record advancing programs through the drug development process, from discovery through IND to registration, informing data driven decisions on dose and schedule, making tough judgement calls where needed

• A thorough understanding of the drug development process, including leading clinical pharmacology or pharmacometrics aspects of non-clinical and clinical