Immatics US, based in Houston, Texas, is a highly innovative biopharmaceutical company developing adoptive cellular immunotherapies against novel cancer targets. For additional information about Immatics, please visit our website www.immatics.com. We are currently seeking applicants for the following position:

Associate Director of Clinical Operations

Immatics US is currently seeking an Associate Director of Clinical Operations to join our team with the ability to operate in an interdisciplinary environment with colleagues from manufacturing, quality, translational and clinical development. Your work will be performed in close collaboration with the MD Anderson Cancer Center and with Immatics Biotechnologies GmbH. Will be responsible for coordinating and managing all aspects of clinical operations to maintain regulatory compliance and meet company timelines and goals for the clinical development program.

Essential Job Functions

  • Manage all clinical operational aspects for implementation of clinical trials from study start-up through database lock, ensuring GCPs and relevant SOPs are met
  • Manage and coordinate study-related vendors and serve as the primary point of contact for contracted CROs, study staff and contract labs; identify potential risks and resolve issues with CROs; control CRO’s budget and approve the invoices
  • Provide input and/or develop study related materials such as Clinical Monitoring Plans, Data Management Plans, protocols, patient informed consent, study procedure manuals, site instructions for specimen collections, subject binder and study drug order forms
  • Coordinate with CROs on site selection, feasibility evaluation, IRB submissions, site initiation and close-out planning; review monitoring reports, protocol deviations and AE listings to ensure reliable quality data are delivered
  • Communicate directly with study site staff and investigators for clinical trials; track patient recruitment and progress to study timelines; support safety reporting and IRB submissions
  • Perform site monitoring visits for clinical trials as needed; coordinate the negotiation of site budgets within guidelines, and provide oversight for site payments per contracts
  • Facilitate study drug orders, and ensure site accountability records are maintained
  • Manage CROs on CRF design, EDC system development & maintenance, source document worksheet development, interim and final statistical analysis plan
  • Maintain clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with Immatics SOPs
  • Support CROs and sites to prepare for clinical audits and to respond to audit findings conducted by internal QA and external regulatory agencies
  • Guide Junior clinical operational personnel for professional development

Minimum Required Education, Experience and Skills

10+ years of work history in clinical research, including 5+ years of experience as Clinical Trial Manager or Project Manager or equivalent in biopharmaceutical or CRO industry

  • Strong knowledge of GCP and other regulatory requirements for pharmaceutical development
  • Advanced knowledge of Microsoft Office to include Word, Excel and PowerPoint
  • Strong verbal and written communications skills
  • Must have strong analytical and reasoning skills
  • Ability to work independently Ability to travel up to 20% of time
  • EDC system design, development and management experience will be beneficial
  • Transplantation or adoptive cellular therapy clinical trial experience
  • Basic knowledge in tumor immunology and oncology
  • Required: Bachelor’s degree in Life Sciences or related field.  Eight additional years of experience in addition to the required years of experience may be substituted in lieu of a master’s degree

Preferred Education, Experience & Skills

  • Advance degree such as Master’s or PHD’s degree in Biology, Immunology, Biotechnology or related field.

 

Please submit resume and cover letter to HR-US@immatics.com

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