The Role: Moderna is seeking an Associate Director of Clinical Operations to manage rare disease programs which may consist of one or more studies. This position will be responsible for initiating and leading clinical programs, inclusive of studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Senior Director, Clinical Operations within Therapeutics. This position will work collaboratively across the rare disease and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. This position may also oversee other therapeutic areas within the TA, including oncology studies. Here’s What You’ll Do: Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs Support the selection, oversight, and management of CROs and other vendors Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures. Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders Perform and document study level Sponsor Oversight of outsourced clinical activities Communicate study-status, cost and issues to ensure timely decision-making by senior management Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna Support program level deliverables/activities Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. Strive for continuous improvement and more efficient ways of working in clinical development Act as a role model for Moderna’s values Here’s What You’ll Bring to the Table: Minimum of BA/BS with at least 8-10 years of trial and clinical program experience, including 4 years of high complexity independent, global trial management experience. Clinical program management experience of 1-2 years is desirable. Experience in oncology is required; experience rare disease is desirable. Robust experience in early and late phase drug development Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc. Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc. Experience in GCP inspections/audits Outstanding verbal and written communication skills, in addition to excellent organizational skills Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry Resilient, Creative, capable problem-solver Excellent organizational skills and ability to work independently Experience in establishing and maintaining relationships with key opinion leaders Some travel required 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 options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ community Generous 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 thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes 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. 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) #LI-DNI - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home