Associate Director/Director, Clinical Operations (Rare Disease)

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
August 17 2019
Ref
R1600
Discipline
Life Sciences, Biology
Organization Type
Biotech
Associate Director/Director, Clinical Operations (Rare Disease)

The Role:

Moderna is seeking a Director of Clinical Operations to manage studies and oversee CRO and vendors, design and work to support clinical operations initiatives . May report to the Moderna's Head of Therapeutic Operations or to a Clinical Operations Lead within the Therapeutic Area. This position will work collaboratively across several rare disease teams for clinical operations activities of individual development programs.

Here's What You'll Do:
  • Study Management may include natural history, 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 Compa n y 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


Here's What You'll Bring to the Table:
  • 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
  • Rare disease including pediatric trial experience is crucial
  • 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,
  • 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; Some travel required


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

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

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; and 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). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

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

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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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