Associate Director, Pharmacometrics

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.

Heres What Youll 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

Heres What Youll 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

Heres What Youll 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. Thats why our US benefits and global well-being resources are designed to support youat 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 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 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 persons 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 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

Were 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 .

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 applicants 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.

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