Director, Clinical Operations
Moderna is seeking a Director of Clinical Operations to design and lead clinical operations initiatives across projects as well as manage external contractors and CROs. Reporting directly to the Moderna's Head of Therapeutic Operations. This position will work collaboratively across several therapeutic area teams for clinical operations activities of individual development programs.
- Study Management of first-in-human and early phase clinical trials of development candidates.
- Manage cross functional leadership and CRO/vendor management related to clinical trial operations aspects.
- Lead in the selection and oversight of CROs and other vendors
- Develop and lead the review of clinical outsourcing strategies and plans
- Manage assigned clinical trial budgets
- Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
- Initiate and lead monitoring oversight activities are conducted in accordance to Moderna and ICH/GCP standards
- Along with other Clinical Development personnel, represent the Company externally to Investigators and trial site administrators
- Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct
- Maintain oversight and participate in the review of departmental SOPs to ensure compliance
- Develop and maintain strong, collaborative relationships with key stakeholders within Moderna
- At least five years of global trial management experience in a clinical research environment, most of which should be in industry and with global trials
- Advanced degree preferred or Bachelor's in a science-based subject
- Cross therapeutic experience including rare disease
- Solid experience in early phase drug development and proven track record of success
- Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
- Cross Collaboration proficiency with other functions such as Research, Drug Supply, and Finance.
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
- Experience in regulatory GCP inspections/audits
- Outstanding verbal and written communication skills including clinical authoring experience including protocols and investigator brochures
- Excellent organizational skills and ability to work independently
- Proven track record of effective leadership in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
- Creative, capable problem-solver
- Experience in establishing and maintaining relationships with key opinion leaders
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.