Moderna
The Role
The
Associate Scientific Director of Pharmacometrics
is responsible for transforming non-clinical and clinical data into analyses that build the basis for model informed drug development (MIDD) of innovative drugs accessible to patients. The Associate Scientific Director will collaborate with cross-functional multidisciplinary teams and develop models to quantify and predict exposure-response relationships to inform optimal decision making on key development questions such as dose selection and trial design. The ideal candidate will work independently to make decisions impacting MIDD goals and to support the design, execution, and analysis of data emerging from clinical studies, will publish manuscripts and present at scientific conferences.
Here's What You'll Do Apply state-of-art quantitative pharmacology and pharmacometrics methods within assigned programs to yield high value pharmacometrics support for critical decisions to advance development candidates
Develop and execute modeling & simulation (M&S) plans to support candidate drug development
Independently develop and report population PK and PK/PD and disease progression analyses
Proactively incorporate and develop approaches and methodologies based on review of relevant scientific literature
Perform meta-analysis using proprietary and/or literature data
Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy
Author M&S sections for regulatory interactions and responses
Participate in maintaining scientific awareness and presence in quantitative pharmacology and pharmacometrics science, preparation of abstracts and manuscripts for publication
Strengthen our pharmacometrics capabilities on a continuous basis by evaluating and incorporating new M&S tools and initiating trainings as appropriate
Actively contribute to a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Here's What You'll Need (Basic Qualifications)
PhD with a focus in pharmacokinetics, pharmacology, pharmaceutics or other related field with minimum of 8+ of drug development experience post PhD
Hands-on proficiency in using pharmacometrics tools including but not limited to NONMEM, R, Julia, Monolix and Phoenix
Deep understanding of pharmacometrics principles and incorporation of M&S strategies
Here's What You'll Bring to the Table (Preferred Qualifications)
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.
Familiar in binary and categorical data analysis, time-to-event (hazard) models, Poisson models, logistic regression, MCMC and Bayesian methods as applied to exposure-response analyses, meta-analyses and Population PK and PKPD analysis would be advantageous
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 in pharmacometrics
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.
Pay & Benefits
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 voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
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 modernatx.com/careers 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, 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
#LI-NH1
The
Associate Scientific Director of Pharmacometrics
is responsible for transforming non-clinical and clinical data into analyses that build the basis for model informed drug development (MIDD) of innovative drugs accessible to patients. The Associate Scientific Director will collaborate with cross-functional multidisciplinary teams and develop models to quantify and predict exposure-response relationships to inform optimal decision making on key development questions such as dose selection and trial design. The ideal candidate will work independently to make decisions impacting MIDD goals and to support the design, execution, and analysis of data emerging from clinical studies, will publish manuscripts and present at scientific conferences.
Here's What You'll Do Apply state-of-art quantitative pharmacology and pharmacometrics methods within assigned programs to yield high value pharmacometrics support for critical decisions to advance development candidates
Develop and execute modeling & simulation (M&S) plans to support candidate drug development
Independently develop and report population PK and PK/PD and disease progression analyses
Proactively incorporate and develop approaches and methodologies based on review of relevant scientific literature
Perform meta-analysis using proprietary and/or literature data
Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy
Author M&S sections for regulatory interactions and responses
Participate in maintaining scientific awareness and presence in quantitative pharmacology and pharmacometrics science, preparation of abstracts and manuscripts for publication
Strengthen our pharmacometrics capabilities on a continuous basis by evaluating and incorporating new M&S tools and initiating trainings as appropriate
Actively contribute to a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Here's What You'll Need (Basic Qualifications)
PhD with a focus in pharmacokinetics, pharmacology, pharmaceutics or other related field with minimum of 8+ of drug development experience post PhD
Hands-on proficiency in using pharmacometrics tools including but not limited to NONMEM, R, Julia, Monolix and Phoenix
Deep understanding of pharmacometrics principles and incorporation of M&S strategies
Here's What You'll Bring to the Table (Preferred Qualifications)
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.
Familiar in binary and categorical data analysis, time-to-event (hazard) models, Poisson models, logistic regression, MCMC and Bayesian methods as applied to exposure-response analyses, meta-analyses and Population PK and PKPD analysis would be advantageous
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 in pharmacometrics
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.
Pay & Benefits
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 voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
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 modernatx.com/careers 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, 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
#LI-NH1