2018-04-26

Clinical Operations Director
Job Opportunity at Clinical Dynamix, Inc.

Posted on Apr 26

http://www.clinicaldynamix.com    888-558-2546

Location: Cambridge, MA
Job Type: Contract
Job ID: W4158396

Global Pharmaceutical Company is hiring three Clinical Operations Directors (Vaccine or rare disease or Oncology) 
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 Head of Clinical Operations and work closely with the Regulatory team of the Chief Medical Officer of Company.
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 Company 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 Company organization.
Here’s What You’ll Bring to the Table:
  • PhD and 10 years’ experience, MS with 10-15 years’ experience or BA with 15-20 years’ experience.
  • At least 8-10 years of management experience in an infectious disease vaccines clinical research environment
  • 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

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. 
 

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