Director, Clinical Risk Management

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
October 13 2019
Ref
R1599
Discipline
Life Sciences, Biology
Organization Type
Biotech
Director, Clinical Risk Management

The Role:

The Clinical Development team at Moderna is looking for an experienced and self-directed leader to proactively manage and establish best practice to systemic risk management across Moderna's clinical trials. Ensures internal alignment on principles and approaches to risk identification, management and governance at the trial and vendor level. The successful candidate will be detailed oriented with a compliance focused approach and with the ability to work with key stakeholders at Moderna and with external partners.

Here's What You'll Do:
  • Drive the overall Clinical Risk Management function at Moderna
  • Oversee risk management and monitoring strategies to ensure alignment, implementation, and compliance
  • Manage the overall clinical risk assessment, control and review process and optimize appropriate tools and guidance documents to support the study teams
  • Together with key team members, ensure adherence to GCP/ICH principles around risk throughout life of study
  • Define the systematic risk management and governance process including requirements for documentation, analysis and performance trends across individual functions and across multiple projects/programs
  • Focus on performance management and delivery of contracted work by vendor and across vendors
  • Collaborate and ensure alignment with key stakeholders across the organization with responsibilities impacting risk management


Here's What You'll Bring to the Table:
  • Minimum of Bachelor's Degree or equivalent in scientific or life science discipline; Master's Degree preferred
  • At least 10 years of experience in clinical research and development
  • Extensive experience with cross functional operational management
  • Extensive experience with compliance/risk management best practices
  • Track record of establishing effective business relationships with internal and external customers
  • Excellent leadership skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe
  • Excellent written and verbal communication skills
  • Excellent project management, leadership, communication, management and organizational skills, as well as a high level of proficiency with problem solving, conflict resolution, negotiation and team building skills
  • Flexibility to adapt to the dynamic needs of a growing biotech company
  • Successful c andidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes


Here's What We'll Bring to the Table:
  • Daily on-site subsidized cafeteria
  • 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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