Associate Director / Director, Clinical Operations, Infectious Diseases 6/3/2020
JOB DESCRIPTIONAPPLY THE ROLE:
Moderna Therapeutics innovative mRNA platform will allow its Infectious Diseases therapeutic area to advance the clinical development of multiple Vaccines over the coming months. Infectious Diseases is therefore recruiting a Clinical Operations Lead to manage these studies. This position will be responsible for initiating and leading phase 1 to 3 clinical trials development, set-up, implementation and completion. This will be accomplished by working with the internal project team and through a preferred provider CRO and other external contractors. This role will report internally to the Senior Director, Clinical Operations for Infectious Disease and work cross-functionally within with Moderna to ensure successful execution of assigned projects.
HERE S WHAT YOU LL DO:
* Leadership of first-in-human through global phase 3 vaccine clinical trials ensuring GCP and FDA Regulatory compliance.
* Work with the internal project team and manage the preferred provider CRO team and vendors to plan and implement clinical trials for multiple vaccine studies.
* Develop and lead the review of clinical outsourcing strategies and plans.
* Manage assigned vaccine clinical trial budgets and resource assignment.
* Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with global operational standards and procedures.
* Initiate and lead monitoring oversight activities are conducted in accordance to Moderna and ICH/GCP standards.
* Represent the Company externally to Investigators and trial site leadership.
* 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 in Clinical Development and the broader Moderna organization.
HERE S WHAT YOU LL BRING TO THE TABLE:
* Minimum of BA/BS with at least 10 years experience. Advanced degree preferred.
* At least 8-10 years of management experience in a clinical research environment. Experience in global Vaccines clinical development highly desired.
* 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 and Program Management
* Thorough command of FDA, MHRA 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, in addition to excellent organizational skills
* Resilient, Creative, capable problem-solver
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)
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 www.modernatx.com.
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.