Manager/Senior Manager, Trial Operations

Location
Boston, MA
Posted
Nov 26, 2021
Ref
Req #69
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders. 

At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.

Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us.  We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon.

The Manager/Senior Manager, Trial Operations will work flexibly across a number of clinical stage trials and projects, acting as a study lead and manager for select clinical trials, and be hands-on in 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. In addition, the successful candidate must have strong project management experience, excellent collaboration skills, demonstrate good judgement, be flexible and detail oriented.
 

The position reports to the Senior Director, Trial Operations and will be located in either the Vancouver, BC, Canada or Boston, MA, USA location; we may consider other locations for an exceptional candidate.
 

RESPONSIBILITIES:

  • Provide clinical trial management leadership for one or multiple clinical studies, Phase 1 to 3, as well as multiple secondary assignments.
  • Collaborate with Clinical Sciences, Biometrics, Regulatory, Medical Writing, Clinical Supplies and Development Program Management to ensure highly integrated cross-functional plans and documents for clinical trials.
  • Develop, propose, and manage plans (including budgets and timelines) 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.
  • 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.
  • Oversee adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice.
  • Develop and update standard operating procedures as required.
  • International travel may be required.
  • Other duties as required from time to time.
  • Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics.

QUALIFICATIONS:

  • A minimum bachelor’s degree in a scientific discipline and/or other healthcare designation (e.g., RN).
  • A minimum of 5-8 years clinical project/study management experience within the pharmaceutical and or biotechnology/biopharmaceutical industry or at a CRO.
  • Experience within pediatrics or rare diseases or the CNS therapeutic area is preferred, but not required.
  • 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 deliver on critical milestones in the successful completion of clinical trials on time and within budget.
  • Strong knowledge and understanding of ICH/GCP and US and Canadian regulatory environments; a comprehensive understanding of clinical trial regulations across multiple jurisdictions with previous experience with CTA and IND submissions preferred.
  • 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 a part of a multidisciplinary team.
  • Exceptional attention to detail and excellent organizational skills.
  • 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 handle highly confidential and sensitive materials and information with complete discretion.
  • Ability to travel internationally.