Director, Clinical Pharmacology page is loaded## Director, Clinical Pharmacologylocations:
Cambridge, Massachusetts:
Clinical Developmenttime type:
Full timeposted on:
Posted Todayjob requisition id:
R18458**The Role**The role is positioned in the Clinical Pharmacology group, Clinical and Quantitative Pharmacology (CQP) function. This individual will bring strong technical and strategic expertise in clinical pharmacology, Model-Informed Drug Development (MIDD), representing CQP on program teams, and contributing significantly to advancing our exciting mRNA platform and therapeutic pipeline.This role will closely partner with CQP colleagues in Pharmacometrics and Quantitative Systems Pharmacology to determine and implement the overall CQP strategies across therapeutic areas, from preclinical development through lifecycle management. Success in this role requires close collaboration with Translational Medicine, Research (including Nonclinical Development), Clinical Development, Clinical Safety and Risk Management, Biometrics, and Regulatory functions to ensure integrated and innovative clinical pharmacology strategies are developed and executed to enable agile development of our exciting pipeline.At Moderna, we are pioneering the development of mRNA medicines to transform patients' lives. As part of our innovative team, you will play a key role in shaping the future of medicine while growing your career in a supportive, collaborative environment.**Here’s What You’ll Do*** Resonsible to develop a fit-for-purpose Clinical Pharmacology development plan, including dose selection and optimization, evaluation plan for special populations, PK/PD and immunogenicity assessment, and pediatric development.* Collaborate with program teams to develop dose selection strategy and support decision makings for first-in-human studies and IND submissions.* Represent CQP in a highly matrixed team setting to drive study execution and operational excellence toward product development goals.* Lead the development of CQP related sections in regulatory documents (e.g., clinical protocols, INDs, regulatory meeting briefing books, summary documents for BLAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions.* Lead/oversee the Clin Pharm data analysis, interpretation, and reporting to inform clinical implications and development decisions* Advocate and represent clinical pharmacology and MIDD strategies with internal and external stakeholders.* Mentor junior team members to contribute to the development of a high-performing Clinical Pharmacology team.* Leverage literature data and collaborate with external consultants, CRO partners and academic sites to problem solve and develop solutions to clinical pharmacology issues and grow organizational knowledge on mRNA platform**Here’s What You’ll Need (Basic Qualifications)*** PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 8-10 years of industry experience in clinical pharmacology* In depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME and quantitative translational sciences* Hands-on quantitative skills, modeling expertise and familiarity with clinical operations and translational sciences.* Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products* Drug development experience in oncology and rare diseases preferred;
expertise in immune therapeutics and/or infectious diseases is a plus.**Here’s What You’ll Bring to the Table (Preferred Qualifications)*** Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred.* Demonstrated ability to work independently, lead functional initiatives, adapt quickly and collaborate effectively in a highly dynamic environment and influence cross-functional teams.* Proficient in using pharmacokinetic, modeling and data visualization software (e.g. Phoenix WinNonlin, R, Monolix, NONMEM, etc).* Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences.* Drug development experience in oncology and rare diseases preferred;
expertise in immune therapeutics and/or infectious diseases is a plus.* Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred.* Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis* Ability to develop and deliver clear and concise presentations for both internal and external meetings* Candidate will be curious in exploring new paths for model informed drug development. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes* Strong publication record* Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams* Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential.* A desire to make an impact as part of a high-growth, transformational company that is **Bold, Relentless, Curious, and Collaborative.****At Moderna, we believe that when you feel your best, you can do your best work.
That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.*** Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs* A holistic approach to well-being, with access to fitness, mindfulness, and mental health support* Lifestyle Spending Accounts to personalize your well-being journey* Family planning and adoption benefits* Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown* Savings and investment opportunities* Location-specific perks and extras**About Moderna**Since 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 people are 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.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit
to learn more about our current opportunities.**Our Working Model**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.Moderna is a smoke-free, alcohol-free, and drug-free work environment.**Equal Opportunities**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, #J-18808-Ljbffr
Cambridge, Massachusetts:
Clinical Developmenttime type:
Full timeposted on:
Posted Todayjob requisition id:
R18458**The Role**The role is positioned in the Clinical Pharmacology group, Clinical and Quantitative Pharmacology (CQP) function. This individual will bring strong technical and strategic expertise in clinical pharmacology, Model-Informed Drug Development (MIDD), representing CQP on program teams, and contributing significantly to advancing our exciting mRNA platform and therapeutic pipeline.This role will closely partner with CQP colleagues in Pharmacometrics and Quantitative Systems Pharmacology to determine and implement the overall CQP strategies across therapeutic areas, from preclinical development through lifecycle management. Success in this role requires close collaboration with Translational Medicine, Research (including Nonclinical Development), Clinical Development, Clinical Safety and Risk Management, Biometrics, and Regulatory functions to ensure integrated and innovative clinical pharmacology strategies are developed and executed to enable agile development of our exciting pipeline.At Moderna, we are pioneering the development of mRNA medicines to transform patients' lives. As part of our innovative team, you will play a key role in shaping the future of medicine while growing your career in a supportive, collaborative environment.**Here’s What You’ll Do*** Resonsible to develop a fit-for-purpose Clinical Pharmacology development plan, including dose selection and optimization, evaluation plan for special populations, PK/PD and immunogenicity assessment, and pediatric development.* Collaborate with program teams to develop dose selection strategy and support decision makings for first-in-human studies and IND submissions.* Represent CQP in a highly matrixed team setting to drive study execution and operational excellence toward product development goals.* Lead the development of CQP related sections in regulatory documents (e.g., clinical protocols, INDs, regulatory meeting briefing books, summary documents for BLAs, responses to regulatory authorities) and represent clinical pharmacology in regulatory interactions.* Lead/oversee the Clin Pharm data analysis, interpretation, and reporting to inform clinical implications and development decisions* Advocate and represent clinical pharmacology and MIDD strategies with internal and external stakeholders.* Mentor junior team members to contribute to the development of a high-performing Clinical Pharmacology team.* Leverage literature data and collaborate with external consultants, CRO partners and academic sites to problem solve and develop solutions to clinical pharmacology issues and grow organizational knowledge on mRNA platform**Here’s What You’ll Need (Basic Qualifications)*** PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 8-10 years of industry experience in clinical pharmacology* In depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME and quantitative translational sciences* Hands-on quantitative skills, modeling expertise and familiarity with clinical operations and translational sciences.* Sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products* Drug development experience in oncology and rare diseases preferred;
expertise in immune therapeutics and/or infectious diseases is a plus.**Here’s What You’ll Bring to the Table (Preferred Qualifications)*** Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred.* Demonstrated ability to work independently, lead functional initiatives, adapt quickly and collaborate effectively in a highly dynamic environment and influence cross-functional teams.* Proficient in using pharmacokinetic, modeling and data visualization software (e.g. Phoenix WinNonlin, R, Monolix, NONMEM, etc).* Outstanding verbal and written communication skills, with the ability to distill complex data for diverse audiences.* Drug development experience in oncology and rare diseases preferred;
expertise in immune therapeutics and/or infectious diseases is a plus.* Platform expertise in mRNA therapeutics, and/or experience with biologics and new modalities preferred.* Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidance on quantitative analysis* Ability to develop and deliver clear and concise presentations for both internal and external meetings* Candidate will be curious in exploring new paths for model informed drug development. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes* Strong publication record* Requires effective skills directed toward driving teamwork, accomplishing results, influencing, and resolving problems across internal and external project teams* Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential.* A desire to make an impact as part of a high-growth, transformational company that is **Bold, Relentless, Curious, and Collaborative.****At Moderna, we believe that when you feel your best, you can do your best work.
That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.*** Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs* A holistic approach to well-being, with access to fitness, mindfulness, and mental health support* Lifestyle Spending Accounts to personalize your well-being journey* Family planning and adoption benefits* Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown* Savings and investment opportunities* Location-specific perks and extras**About Moderna**Since 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 people are 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.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit
to learn more about our current opportunities.**Our Working Model**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.Moderna is a smoke-free, alcohol-free, and drug-free work environment.**Equal Opportunities**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, #J-18808-Ljbffr