Director, Clinical Operations, Therapeutics

The Role:
Moderna is seeking a 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 Executive Director, Clinical Operations within the Therapeutics Development Therapeutic Area. 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 such as autoimmune and/or cardiovascular.
Here’s What You’ll Do:

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

Here’s What You’ll Bring to the Table:

• Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management Advanced degree preferred.
• Experience in GCP inspections/audits
• Some travel required
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Excellent organizational skills and ability to work independently
• Experience in rare disease is required. Experience in complex disease areas within autoimmune and oncology are desirable.
• Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
• Experience in establishing and maintaining relationships with key opinion leaders
• 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.
• Resilient, Creative, capable problem-solver
• Robust experience in early and late phase drug development
• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Exclusive preferred pricing on Peloton fitness equipment
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Discretionary winter shut down
• Location-specific perks and extras!
• Adoption and family-planning benefits
• Free parking or subsidized commuter passes
• Volunteer time to participate within your community
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Highly competitive and inclusive medical, dental and vision coverage options
• Paid sabbatical after 5 years; every 3 years thereafter
• Vacation, sick time and holidays
• Free premium access to fitness, nutrition, and mindfulness classes
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• 401k match and Financial Planning tools

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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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