Associate / Director, Clinical Operations, Infectious Diseases
Moderna Therapeutics' innovative mRNA platform will allow its Infectious Diseases therapeutic area to start the clinical development of multiple Infectious Disease / 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 and 2 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 and phase 2 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 several new vaccines.
- 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 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 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 Infectious Disease / Vaccines highly desired.
- 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 R&D, Finance and production
- 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
- Creative, capable problem-solver
Here's What We'll Bring to the Table:
- Daily on-site catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- 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
- 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
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.