Job Details

Summary

About Us:

Eupraxia Pharmaceuticals Inc. is a publicly owned novel pharmaceutical company based in Victoria, British Columbia. We are drug delivery company that focusses on delivering the right therapeutics to the right area in the right dose to improve patient lives. Our lead product candidate is an extended-release steroid intended to provide long term pain relief for patients suffering with knee osteoarthritis and we are actively expanding our portfolio of products.

We are looking for people that like to be part of a fast-paced, growing company that fosters creative spirit and integrated teamwork.

Job Description:

This role is responsible for overseeing the company’s clinical research activity involving all aspects of clinical trials execution. The job holder is responsible for the development of clinical protocols to support the company’s product strategy, working with colleagues to ensure appropriate data collection and management and the development of final reports in compliance with appropriate standard operating procedures, regulatory and medical standards. The position interacts with various groups within the company and external to the business to oversee clinical research activities. This role reports to the CMO.

Responsibilities:

  • Responsible for planning, management and reporting of clinical studies through oversight of cross-functional study activities, proactive issue resolution and communications of study timelines and deliverables.
  • Identifies and manages suitably qualified internal personnel and external vendors to achieve clinical milestones and quality standards.
  • Organises and manages interactions with external therapeutic area experts to advise on and support implementation of clinical development plans
  • Gains alignment with various internal partners and stakeholders on clinical goals and resource needs. Includes working with core project teams to establish appropriate budgets and other resource plans
  • Ensures that studies are conducted in accordance with SOPs, GCP and regulatory guidelines.
  • Serves as primary author / coordinating author for:
    • Clinical trial protocols / strategy
    • Investigator Brochure
    • Clinical study report
    • Annual safety report
    • Publications
  • Works with regulatory and other partners/stakeholders in the completion and submission of IND (investigational new drug) applications and filings
  • Participates in FDA or other health authority interactions.

Requirements:

  • Experienced Clinical Scientist with a strong insight into research
  • 10+ years of direct experience in Clinical Development, in positions of increasing responsibility in a biotech or pharmaceutical environment.
  • Extensive experience ranging from Phase 1 clinical development through NDA, encompassing multiple phases of clinical development and managing complex clinical trials.
  • A track record of success in efficiently executing complex clinical trials that are designed to demonstrate a clear competitive advantage over existing therapies, while compressing timelines.
  • Experience in dealing with the EMA, the FDA and other regulators on all aspects of clinical trial development.
  • Exposure to Rheumatology and Inflammatory Diseases is preferred. Experience including oncology, an advantage.
  • Negotiation experience in working with CROs, and / or co-development partners.
  • Proven ability to work successfully across functions in a matrix management approach
  • Broad knowledge of the drug development process, clinical development planning, clinical research methodologies and execution, regulatory requirements; some knowledge of biostatistics and epidemiology
  • Detailed knowledge of general pharmaceutical science in its application to clinical development programs
  • proven track record in delivering global clinical research programs to budget and timeline specifications
  • successful experience in coordinating internal and external resources for clinical development, and in working with pharmaceutical partners
  • direct hands-on experience in managing high-quality successful clinical trials and clinical trial project teams
  • experience with orphan drugs and rare diseases a plus
  • demonstrated qualities of senior management; the ability to set and communicate goals, and to drive efforts, overcome obstacles and achieve results within budget and timeline specifications; exceptional organizational, interpersonal and communication abilities; team building and team-oriented approach; a willingness to contribute at all levels; high ethical standards and integrity; independent thinking; excellent judgment in making information and logic-based decisions
  • Excellent verbal, written and interpersonal communication skills.

Location:  Flexible but it limited to North America, able to work PST hours.  Head office is in Victoria, BC

This is an opportunity to work in a small, entrepreneurial and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture. We offer a competitive salary, excellent benefits and career development opportunities.

How to Apply:

  • Please send your CV and cover letter to careers@eupraxiapharma.com .
  • While only short-listed candidates will be notified, we thank each applicant for their submission.