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Overview
Associate Director, Clinical Operations at Moderna to manage studies within the Clinical Operations, Therapeutics and Oncology Therapeutic Area. This role is responsible for initiating and leading clinical trials across all phases, overseeing CROs and vendors, and working cross-functionally on clinical operations strategy and related initiatives. The position will focus on ongoing studies in metabolic rare diseases, with potential future support for oncology. Here’s What You’ll Do
Accountable for delivery of assigned clinical study 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 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 Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities 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 the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures 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 Manage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programs 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 at the discretion of the Senior Director, Clinical Operations Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise 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 at least 4 years of independent clinical trial management experience and full trial life cycle experience (e.g., start-up, conduct, closure). Advanced degree preferred. Robust experience in oncology required. Experience in immuno-oncology desirable. Experience in ultra rare disease desirable but not required. The ideal candidate has experience with high complexity clinical trials, and late-stage clinical trials, including inspection readiness activities. 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 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 Benefits
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. 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, visit modernatx.com/careers to learn more about our current opportunities. Our Working Model
We embrace a 70/30 in-office work model to foster collaboration, mentorship, and innovation. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities
Moderna is an equal employment opportunity and non-discrimination employer. We consider qualified applicants without regard to 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 characteristic protected by law. Moderna is an E-Verify Employer in the United States. We welcome applicants regardless of criminal histories where allowed by law. Accommodations
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. If you require an accommodation during the hiring process or to perform the essential functions of the position, contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice
This position may involve access to technology or data subject to U.S. export control laws. Employment is contingent upon access to export-controlled information in compliance with U.S. law. Only U.S. persons are eligible for this role; Moderna cannot sponsor non-U.S. persons for export control licenses.
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Associate Director, Clinical Operations at Moderna to manage studies within the Clinical Operations, Therapeutics and Oncology Therapeutic Area. This role is responsible for initiating and leading clinical trials across all phases, overseeing CROs and vendors, and working cross-functionally on clinical operations strategy and related initiatives. The position will focus on ongoing studies in metabolic rare diseases, with potential future support for oncology. Here’s What You’ll Do
Accountable for delivery of assigned clinical study 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 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 Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities 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 the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures 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 Manage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programs 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 at the discretion of the Senior Director, Clinical Operations Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise 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 at least 4 years of independent clinical trial management experience and full trial life cycle experience (e.g., start-up, conduct, closure). Advanced degree preferred. Robust experience in oncology required. Experience in immuno-oncology desirable. Experience in ultra rare disease desirable but not required. The ideal candidate has experience with high complexity clinical trials, and late-stage clinical trials, including inspection readiness activities. 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 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 Benefits
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. 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, visit modernatx.com/careers to learn more about our current opportunities. Our Working Model
We embrace a 70/30 in-office work model to foster collaboration, mentorship, and innovation. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities
Moderna is an equal employment opportunity and non-discrimination employer. We consider qualified applicants without regard to 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 characteristic protected by law. Moderna is an E-Verify Employer in the United States. We welcome applicants regardless of criminal histories where allowed by law. Accommodations
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. If you require an accommodation during the hiring process or to perform the essential functions of the position, contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice
This position may involve access to technology or data subject to U.S. export control laws. Employment is contingent upon access to export-controlled information in compliance with U.S. law. Only U.S. persons are eligible for this role; Moderna cannot sponsor non-U.S. persons for export control licenses.
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