<< back to all current openings

Associate Director, Clinical Operations


[ October 1, 2019 ]

We are seeking an Associate Director, Clinical Operations to join our team. The position is office-based with occasional travel required, based on the needs of the clinical projects.

Reporting to the Senior Director, Clinical Operations, the Associate Director will work flexibly across a number of clinical stage projects, providing project management support, data compilation, review and analysis, clinical trial set-up and management, and operational support activities.  This is an excellent opportunity for someone with strong organizational skills and the ability to work independently on a variety of tasks and projects simultaneously. In addition, the successful candidate must have strong project management experience, good judgment, be flexible when different tasks arise, and be detailed oriented.

RESPONSIBILITIES:

  • Provide clinical operations leadership to support design, development, execution and delivery of a clinical program in accordance with the clinical development plan/strategy and timelines
  • Oversee Clinical Trial Managers in providing clinical project management support and the completion of assigned activities related to multiple clinical projects
  • Work with all relevant groups (internal and external) to ensure all assigned activities are managed appropriately
  • Develop and implement plans (including budgets and timelines) for assigned programs, studies and activities
  • Lead in the selection and oversight of CRO activities and other clinical vendors to ensure study quality meets Xenon and regulatory requirements including preparing Requests for Proposals, coordinating the evaluation of the proposals, and providing input into the selection of clinical service providers
  • Oversee and assist in all aspects of project development, including the development of clinical trial protocols, consent forms, case report forms, study plans, and other essential regulatory documents
  • Assist with the selection of qualified investigators and study sites
  • Manage clinical trial budgets, timelines, and data safety review processes
  • Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice
  • Anticipate potential program/study issues and prepare contingency plans
  • Manage escalation of program/study related issues and communicates as appropriate with senior management and other R&D functions
  • Work collaboratively within a team environment and interacts with clinical and nonclinical colleagues
  • Develop and update standard operating procedures as required

QUALIFICATIONS:

  • A bachelor’s degree in a scientific discipline and/or a healthcare professional (e.g., RN)
  • A minimum of 15 years of industry experience in the biotechnology/biopharmaceutical or CRO industry; minimum 8 years in a leadership and management capacity
  • A minimum of 10 years of Clinical Trial Management experience, including running global studies
  • Experience within the CNS therapeutic area preferred, particularly in epilepsy
  • A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas (e.g., CMC, nonclinical/toxicology, Regulatory Affairs etc.)
  • Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities
  • Demonstrated ability to successfully manage and complete clinical trials on time and within budget
  • Strong knowledge and understanding of ICH/GCP and US and Canadian regulatory environments; previous experience with CTA and IND submissions preferred
  • Excellent oral and written communication skills
  • Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team
  • Exceptional attention to detail and excellent organizational skills with a desire to roll up one’s sleeves
  • Ability to thrive in a dynamic and fast-paced environment
  • Ability to prioritize duties and manage multiple matters from start to finish with minimal supervision and with a demonstrated ability to lead change and make independent decisions
  • Ability to effectively and positively work with executive-level management
  • Ability to handle highly confidential and sensitive materials and information with complete discretion and having good judgment in working with clients, and occasionally under ambiguous or challenging circumstances
  • A dynamic self-starter with a positive attitude and strong influencing skills

To apply for this position, please e-mail your resume and cover letter to careers@xenon-pharma.com and include “Associate Director, Clinical Operations” in the subject line. All attachments must be saved as one file and be named: “Your Full Name – Associate Director, Clinical Operations”. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.