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 managementEnsures 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 pipelineEnsures 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 predictionDevelop, 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 meetingsRepresent an expert clinical pharmacology perspective on Moderna's internal governance committees to ensure robust and data driven go/no go, and dose decisions for programsDrive innovative pharmacology approaches to advance our mRNA platformPartner with internal and external subject matter experts to inform all major go/no-go development decision criteria to advance programsAs a member of the translational medicine leadership team, shape the future of the translational medicine organization at ModernaHere's What You'll Bring to the Table:PhD in Clinical Pharmacology, Pharmacometrics, or related disciplineDevelopment background in oncology, rare diseases, infectious diseases and/or mRNA therapeuticsA 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 neededA thorough understanding of the drug development process, including leading clinical pharmacology or pharmacometrics aspects of non-clinical and clinical study design, clinical protocol development, clinical study delivery, clinical study reports, clinical pharmacology health authority filings and responsesA robust external network of external clinical pharmacology and pharmacometrics thought leaders and partnersProven experience, track record, and acumen as a people leader, including leading top tier team performance, as well as building a strong team culture and in motivating, developing, mentoring, and retaining talentOutstanding verbal and written communication skills including the ability to distill and communicate complex data, topics, and recommendations to non-expert stakeholders Exceptional problem solving, stakeholder management, interpersonal partnering, working in the matrix and influencing cross-functional program teams and work streams to overcome obstacles and deliver for the enterpriseA strong publication record in clinical pharmacology, population PK, and/or pharmacometricsStrong thought leadership and visibility in the external clinical pharmacology communityModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at ****** . (EEO/AAP Employer) -