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Preclinical Immunotherapy Lead

Job Location:
Port Coquitlam, BC

Company Profile

Novelogics is a private Company based in British Columbia, Canada and has identified an overlooked area in cancer biology that potentially represents a missing piece of the ‘cancer puzzle’. Unlike antibody drugs that attach directly to the cancer cell surface, our proprietary “antibody immunotherapy” acts as an “Interceptor” of unattached immunosuppressive proteins that have the capacity to shut down critical cancer-killing immune cells. This drug is specifically designed to enable effective restoration of these immune cells and to limit further immune suppression, thereby facilitating safe treatment for cancer patients while significantly improving overall survival times and quality of life. Visit www.novelogics.com

Role Summary

The Preclinical Immunotherapy Lead will report directly to the CSO, and will be responsible for implementing and directing the preclinical strategy of Novelogics’ assets.  The successful candidate will possess a solid understanding of US and international regulations and the drug approval process. A clear understanding of translational medicine is required, including but not limited to, basic pharmacokinetics/pharmacodynamics principles, the use of biomarkers, and data interpretation as they apply to immunotherapy antibody drug development.  This role will manage the design and execution of preclinical studies, oversight and interpretation of preclinical data and interactions with cross-functional groups and contractors.  This role will also include external interactions with regulatory authorities, key opinion leaders (KOL), scientific and academic collaborators, patient advocacy organizations, and other external stakeholders.

 

Responsibilities

  • Lead and oversee the design and execution of all preclinical studies
  • Formulate preclinical development plans – ensure integration of preclinical plan and strategy with the needs of other stake holders (e.g., Regulatory Affairs, Medical Affairs, Commercial, etc.)
  • Provide scientific input during development, execution and completion of preclinical studies
  • Partner closely with other functional areas within R&D (pharmacology, preclinical, translational medicine, statistics, safety, etc.) and external investigators and consultants (KOL, scientific advisory board) and vendors to facilitate the execution of preclinical studies and programs including IND filings
  • Interpret preclinical data and take a major role in the preparation of reports, regulatory submissions and publications
  • Identify, interact and build collaborative relationships with KOLs and academic organizations to assure incorporation of latest methods and guidelines into clinical development plans
  • Oversee scientific advisory board meetings to obtain strategic input into preclinical program development
  • Prepare and present study status and strategy to management
  • Serve as lead representative with regulatory agencies

Qualifications

  • 5+ years of pharmaceutical development or other relevant experience required
  • Thorough knowledge of GCP and ICH guidelines for clinical research and regulatory submissions (NDAs and/or BLAs, INDs), and other regulatory documents (CSRs, IB and clinical study protocols) required
  • Demonstrated ability to manage and/or work on cross-functional teams
  • Success in working with and influencing key external stakeholders (i.e. KOLs, investigators) including presenting and responding to FDA and other regulatory authorities
  • Solid understanding and experience with US and International regulatory authorities and the drug approval process
  • Experience in rare diseases is desirable, but not required
  • Travel – approximately 15%

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Novelogics’ culture and core values – courageousness, creativity, selflessness and humor
  • Collaborative with excellent organizational and time management skills
  • Strong attention to detail and ability to work effectively with cross functional teams in leading complex programs and successfully leverage internal and external partnerships
  • Outstanding leadership skills and ability to problem solve
  • Excellent strategic planning, written and oral communication skills

How to Apply:

Please submit your resume and cover letter in PDF format outlining your fit to: info@novelogics.com

We thank you in advance for your interest. We will contact you directly should we wish to arrange a meeting to discuss this position further.

Closes:

March 7, 2019