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Associate Director Clinical Compliance, Clinical Development

Company: Moderna Theraputics
Location: Cambridge
Posted on: June 12, 2021

Job Description:

The Role:

In this new role, the successful candidate will provide direction and oversight of clinical trial/program compliance. The candidate will work to support clinical teams across different stages of development and across therapeutic areas. The successful candidate will be skilled at both understanding and applying global compliance regulations and processes to trials as they advance through clinical development.

The position requires a collaborative partnership with cross functional team members across the organization. The candidate will work to ensure the needs of the teams are addressed with a collaborative outlook and be solution oriented to ensure standards, processes and work instructions are built with the needs of the business.

Here's What You'll Do:

  • Collaborate with Clinical Development to ensure all trials are conducted in compliance with global regulations, ICH/GCP and applicable business processes and practices
  • Review work and workflows of teams to ensure clinical compliance and provide guidance on training or improvement in processes
  • Keep abreast of regulatory developments across industry as well as evolving compliance best practices
  • Ensures an effective training program is maintained for all required compliance/regulatory training.
  • Collaborate with client stakeholders to answer compliance questions or direct compliance issues to appropriate subject matter experts
  • Ensure that compliance issues associated with clinical audits are properly evaluated and adequately addressed in collaboration with Clinical QA.
  • Coordinate assessments of line functions to ensure adherence to stated policies/standards and lead associated work streams as needed
  • Track and report on KRIs/KQIs for Clinical Development

Here's What You'll Bring to the Table:

  • Bachelor's degree in a life science or allied health field (e.g. nursing, medical or laboratory technology)
  • At least 5-10 years' experience in clinical research with direct clinical compliance oversight
  • Excellent written and oral communication skills
  • Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
  • Good organizational/prioritization skills for the management of clinical development compliance
  • Proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
  • Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with cross-functional teams and will be relentless in pursuing successful quality outcomes

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)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

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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Keywords: Moderna Theraputics, Cambridge , Associate Director Clinical Compliance, Clinical Development, Other , Cambridge, Massachusetts

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