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.

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.

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 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 [email protected]. 

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.

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