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Associate Director, Clinical Operations Infectious Disease at Moderna Therapeutics in Cambridge, Massachusetts

Posted in Other 30+ days ago.

Type: Full Time





Job Description:

The Role:
Moderna is seeking an Associate Director of Clinical Operations to manage Infectious Disease programs which may consist of one or more studies. This position will be responsible for initiating and leading clinical trials 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 the Infectious Disease Therapeutic Area. This position will work collaboratively across the Infectious Disease teams and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.

Here s What You ll Do:
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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
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Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
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Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholders
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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
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Support the selection, oversight, and management of CROs and other vendors
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Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
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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
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Manage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
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Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
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Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders
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Perform and document study level Sponsor Oversight of outsourced clinical activities
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Communicate study-status, cost and issues to ensure timely decision-making by senior management
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Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
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Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
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Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
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Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna
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Strive for continuous improvement and more efficient ways of working in clinical development
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Act as a role model for Moderna s values

Here s What You ll Bring to the Table:
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Minimum of BA/BS with at least 5-8 years of trial and clinical program experience. Advanced degree preferred.
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Experience in vaccine development highly desired
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Solid experience in early and late phase drug development
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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.
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Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
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Experience in GCP inspections/audits
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Outstanding verbal and written communication skills, in addition to excellent organizational skills
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Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
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Resilient, Creative, capable problem-solver
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Excellent organizational skills and ability to work independently
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Experience in establishing and maintaining relationships with key opinion leaders
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Some travel required

Here s What We ll Bring to the Table:
- On-site subsidized cafeteria or catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- Free annual corporate membership to Bluebikes
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Eligible for Moderna Month ? (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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