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Manager / Senior Manager, Clinical Microbiology

Position Summary:

The Manager / Senior Manager of Clinical Microbiology will represent the microbiology function on one or more clinical trial teams while taking a leadership role on key activities related to anti-infective clinical development.  In addition, this position will play a pivotal role in the establishment of IND- and NDA/MAA-enabling pre-clinical microbiology packages and in preparation of global regulatory filings.

Essential Functions:

  • Independently lead microbiology aspects of study start-up and ongoing operations for global clinical trials.
  • Make significant contributions to the drafting and completion of key sections of INDs, NDAs and briefing books.
  • Represent the function at Advisory Boards and Regulatory Agency meetings as needed.
  • Provide product support and competitive intelligence insights to Marketing and Medical Affairs.
  • Lead development of Antimicrobial Susceptibility Testing (AST) systems for clinical stage compounds.
  • Design and oversee key pre-clinical NDA-enabling microbiology studies.
  • Collaborate with Discovery Microbiology and Early Development teams to develop plans for successful transition of lead candidate molecules into late clinical development.
  • Effectively manage relationships with KOLs, CROs and academic collaborators to ensure delivery of high-quality results/study reports on time and on budget.
  • Proactively propose and lead writing of abstracts and manuscripts.
  • Communicate scientific data and conclusions effectively internally and externally.

Preferred Experience:

  • 5+ years of infectious diseases clinical development experience including successful completion of a Phase 2 or Phase 3 study.
  • Broad experience working with external vendors or consultants on design and execution of collaborative research studies and in interacting with Key Opinion Leaders.
  • Extensive expertise in clinical microbiology, CLSI standards and in vitro susceptibility testing methods.
  • Working knowledge of infectious diseases in vivo efficacy and PK/PD models.

Preferred Education:

  • PhD in a relevant scientific discipline or M.S./B.S. with appropriate experience in clinical development.

Preferred Additional Skills:

  • Experience with microbiology activities required to support an NDA, including authoring of microbiology sections of regulatory submissions is a strong plus.
  • Ability to develop department level resourcing and budget plans for individual projects.
  • Experience with grant application writing.
  • Excellent scientific writing, presentation and interpersonal communication skills.
  • Work independently with minimal supervision and effectively within cross-functional teams.
  • Proficiency with Microsoft Word and Excel.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically and internationally.
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