Associate Director, Trial Operations (Trial Master File)

Who We Are:

Xenon Pharmaceuticals ( NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. 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 product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 “X-NOVA” clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. 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:

We are seeking an Associate Director, Trial Operations (Trial Master File), to join our team. The Associate Director, Trial Operations (Trial Master File) will be a key member of a highly collaborative Clinical Development team. The Associate Director, Trial Operations (Trial Master File) is accountable for providing strategic operational leadership, planning, oversight, and delivery of an Inspection Ready Trial Master File (TMF) for Xenon’s clinical trials. The Associate Director, Trial Operations (Trial Master File) is also responsible to lead key strategic records management initiatives and continuous improvement activities to sustain a successful TMF Business Model.

The Associate Director, Trial Operations (Trial Master File) will have proven leadership ability in a fast paced, multi-location environment and interact with all levels of internal staff, as well as external stakeholders, including CRO’s.

This position reports to the Vice President, Trial Operations and will be in Boston, MA, USA. The level of the position will be commensurate with the candidate’s education and industry experience.

RESPONSIBILITIES:

• Leads and drives the development of TMF-related documentation: SOPs, WIs, Job Aids and other tools (reference materials, flowcharts, guidance’s, etc.).
• Leads the cross functional identification and implementation of Xenon’s electronic Trial Master File platform to ensure an inspection ready TMF.
• Serves as subject matter expert for the eTMF, providing mentorship, leadership and guidance to cross functional team members on the set up, maintenance and archival of our TMFs.
• In collaboration with the CO Study Team, Vendors, Functional Group Representatives and other Stakeholders, ensures the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards.
• Performs analysis of key performance indicators related to clinical trial accuracy, timeliness and completeness of TMFs against milestone-based projections, proactively identifying issues and required remediation.
• Oversees clinical trial document quality control activities to ensure that study TMFs are inspection ready.
• Prepares for and participates in internal or external audits/inspections including providing audit/inspection responses.
• Demonstrates technical and strategic knowledge of applicable regulatory requirements, including electronic technology industry standards, applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements related to clinical document management and records management creation.
• Develops and maintains close working relationships with other functional areas outside of Trial Operations e.g. Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, Vendors etc. to facilitate TMF development.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Other duties as assigned.
  
  

QUALIFICATIONS:

• Associate Director will have a minimum of bachelor’s degree with a minimum of 8 years relevant management experience working directly with clinical trial documentation a pharma, biotech or CRO environment. We will consider a combination of degrees and experience.
• 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. 
• Project management experience working with vendors while partnering to implement a new TMF system.
• Strong knowledge and understanding of ICH/GCP and US and Canadian regulatory environments; a comprehensive understanding of clinical trial regulations across multiple jurisdictions.
• Experience in preparing for and participating in regulatory inspections.
• Excellent oral and written communication skills. 
• 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 up to 15%, both domestically and internationally. 
  
  

The base salary range for this role is $162,100 to $205,000 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.

US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here .

To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

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