Associate Director, Ndds Study Management & Outsourcing

The RoleAt Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic, diverse, and innovative workplace where every individual's contribution is vital.In this role, youwill serveas the Associate Director, Nonclinical Drug Development Science (NDDS), Study Management & Outsourcing. You will apply your people management and subject matter expertise in the execution of nGLP and GLP in vivo studies in both discovery and development programs to drive platform and program initiatives. Excellent leadership and communication skills and comfort working in a dynamic, fast-paced, cross-functional team environment are required.Here's What You'll DoLead the NDDS, Study Management and Outsourcing (SMO) team in alignment with the corporate mindsets, to execute on Moderna's ambitious and dynamic agenda to deliver transformational medicines and vaccines to patients.Collaborate broadly with nonclinical functional area representatives and leaders in toxicology, pathology, DMPK and bioanalytical, as well as with cross functional partners (CMC, Analytical Development and Platform Research), to execute and manage the outsourcing of research and nonclinical activities to external vendors/CROsProvide outsourced study management oversight and training in protocol development, test article projections and shipments, and review of study deliverables (reports, CTD tables, SEND datasets) and ensuring NDDS alignment and standards are maintained.Participate in development and implementation of a strategy for outsourcing nonclinical activities. Support CRO quality oversight.Accountable for defining and managing the overall workflows to enable study conduct and execution of milestone deliverables in a timely manner.Collaborate and provide input cross-functionally on best practices for laboratory techniques, study development, conduct, data deliverables and reporting processes with a keen eye on efficiency and creativity in approach.Anticipate, troubleshoot and suggest solutions for study-related issues that arise and appropriately escalate as needed for resolution.Support business operations in the execution of SOW, invoices, budget monitoring and quarterly budget reviewsManage and prioritize multi-factorial and fluid timelines. In addition to people management and mentorship and serving as Head of the SMO function, the incumbent will also serve as an independent contributor for a select number of programs/studies as a Study Monitor/SMO Lead.Here's What You'll Need (Minimum Qualifications)A BSc in life science or relevant scientific field (e.g., Biology, Biomedical Sciences, Chemistry, Pharmaceutical Sciences).A graduate degree and/or post-graduate qualification in a relevant discipline preferred.7+ years of experience in thepharmaceutical/biotechindustry, with substantial experience innonclinical in vitro and in vivo (rodent and non-rodent) study execution and study management experience using small molecules and biologics and knowledge of Good Laboratory PracticesRelevant knowledge/experience of CRO workflows including in life study conduct, in life procedures, protocol best practices and report coordination including knowledge of adjacent analytical chemistry, bioanalytical assay, DMPK or other CRO study monitoring experience a plus.Relevant knowledge/experience of CRO workflows in support of method development, qualification and validation of required assays to support in-life data deliverables. Bioanalytical and DMPK experience a plusExperience with and a passion for people management, team building, and creative solution seeking.Proficient with Windows-based applications (e.g., Excel, Word, Outlook, Teams, SharePoint, PowerPoint, Smartsheet).Professional, clear and effective verbal and written communication with colleagues of various backgrounds and levels, including scientific/technical.Successful candidate will be bold in proposing creative ideas and creative solutions to their work. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomesHere's What You'll Bring to the Table (Preferred Qualifications)Attention to detail and quality, and ability to deliver work on time.Demonstrated ability to work successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and/or strategic directions.Experience in significantly impacting departmental and organizational initiatives that have shaped research strategies.A desire to make an impact as part of a high-growth, transformational company that isBold, Relentless, Curious, and Collaborative.Moderna 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) #LI-JW2-