- Accountable for delivery of assigned clinical 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
- 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
- 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
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associate director, clinical operations - Cambridge, MA, United States - Moderna, Inc.
Description
The Role:Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical 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 studies in other therapeutic areas within the TA, including oncology studies.
Here's What You'll Do:
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.
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 (EEO/AAP Employer)
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