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Manager, Trial Operations

4 months ago

Vancouver, British Columbia, Canada Xenon Pharmaceuticals Inc. Full time

Who We Are:
At Xenon Pharmaceuticals (

NASDAQ:
XENE), we are committed to providing a brighter future for patients suffering from neurological disorders.

Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver innovative medicines for patients in need.

We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.


What We Do:
We are advancing an exciting pipeline of neurology-focused therapies, with a focus on commercializing novel treatments for epilepsy.

Building upon the positive results and compelling data from our XEN1101 Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our XEN1101 Phase 3 program includes studies in adult patients with focal onset seizures and primary generalized tonic clonic seizures.

In addition, XEN1101 is being evaluated as a treatment for major depressive disorder in both a company-sponsored Phase 2 clinical trial, as well as an investigator-led proof-of-concept study.

Xenon's proprietary, pediatric formulation of ezogabine, XEN496, is being studied in a Phase 3 clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy.

We are also proud of the leading-edge science coming out of our discovery labs, where many innovative, early-stage research programs are underway.

In addition to these proprietary programs, our pipeline includes clinical-stage partnered programs with valued collaborators.

Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.


About the Role:

RESPONSIBILITIES:

  • Provide clinical trial management leadership for one or multiple clinical studies, Phase 1 to 3, as well as multiple secondary assignments.
  • Collaborate with crossfunctional team members to ensure highly integrated plans and documents for clinical trials.
  • Develop, propose, and manage plans for assigned studies and activities.
  • Lead the preparation of Requests for Proposals (RFPs) in collaboration with other internal team members, coordinate the evaluation of proposals and provide input into the selection and contracting of Contract Research Organizations (CRO) and other clinical service providers.
  • Manage contracted service providers to deliver against the contracts.
  • Assist with the selection of qualified investigators and study sites.
  • Oversee study budgets and ensure vendors are invoicing appropriately.
  • Develop and manage study timeline and study metrics crossfunctionally.
  • Conduct risk assessments, mitigation strategies and contingency planning.
  • Communicate with internal/external team to proactively recognize challenges and work crossfunctionally on strategies to mitigate/resolve.
  • Actively participate in all aspects of clinical trial operations, including the coordination, writing, review and/or finalization of clinical trial protocols, consent forms, case report forms, study plans, safety reviews and other essential regulatory documents.
  • Train and mentor new staff or peer mentorship of new hires.
  • Actively participates in documentation, sharing and implementation of trial conduct best practices and lessons learned with junior staff.
  • Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice.
  • Develop and update standard operating procedures as required.
  • Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics.
  • Other duties as assigned.

QUALIFICATIONS:

  • A bachelor's degree in a scientific discipline and/or other healthcare designation (e.g., RN).
  • A minimum of 5 years clinical project/study management experience within the pharmaceutical and or biotechnology/biopharmaceutical industry or at a CRO.
  • Ability to lead crossfunctional team through all activities in the full clinical study life cycle.
  • Strong vendor management skills and experience managing outsourced work.
  • A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas.
  • Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities.
  • Knowledge of Health Authority regulatory requirements and ICH/GCPs
  • Excellent oral and written communication skills.
  • Strong interpersonal skills and ability to foster strong collaborative relationships with internal and external team members.
  • Ability to work both independently and collaboratively as a part of a multidisciplinary team.
  • Exceptional attention to detail and excellent organizational skills.
  • Ability to thrive in a dynamic and fastpaced environment.
  • Ability and willingness to travel 510% of the time (internationally and domestic).