Xenon Seven

Senior Manager, Data Management

Vancouver · Senior

Sponsorship not specifiedDetected 49 days ago

GCPRESTClinical TrialsLeadershipCollaborationBiostatistics

About the role

We are seeking a Manager/Senior Manager, Data Management to join our team.
The Manager/Senior Manager will be a key member of a highly collaborative Clinical Development team.
The Manager/Senior Manager will thrive in a fast paced, multi-location environment and interact with internal cross-functional colleagues, as well as external stakeholders, including, but not limited to CROs.

Responsibilities

In collaboration with Clinical Sciences, Biostatistics, Clinical Operations, and other key Development functions, responsible for the design of clinical trial databases, which includes, but not limited to, CRF Development, Database Validation, and Data Review tools in accordance with ICH/GCP guidelines and current regulatory requirements.
Optimize data management and collection activities by reviewing protocols for cross-trial consistency and identifying standard case report form modules.
May support the creation of SDTM datasets, which may include oversight of external vendors.
May propose, draft, and maintain relevant Standard Operating Procedures and other policies and procedures relevant to the department
May propose, draft, and maintain relevant Standard Operating Procedures and other policies and procedures relevant to the department; may participate in systems selection and implementation activities.
The Manager/Senior Manager will lead and manage data management activities for assigned products, product candidates and/or clinical trials in all phases of clinical development (Phases 1-4).

Requirements

A minimum of 5 years' management level experience in a pharma or biotech environment.
Job level commensurate with years of experience.
Strong experience in data management-related activities, with thorough understanding of the clinical trial process and regulatory requirements, including CDISC.
Experience in CRO management.
Ability to be hands-on with database cleaning, generate patient level listings as needed.
Ability to travel up to 10%, both domestically and internationally.
International travel may be required.
Bachelor's degree in a scientific, medical, computer science or related field
A minimum of 5 years' management level experience in a pharma or biotech environment. Job level commensurate with years of experience.
Strong experience in design and validating EDC databases and performing data review
familiar with safety laboratory data management and dictionary coding for adverse events and medications.
Experience in CNS, pediatric rare disease area and e-diary database design and implementation are preferred.
Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company.
Proven ability to collaborate in high performing teams, excellent conflict resolution skills.
Be science and data driven while at the same time, be creative and flexible in strategic thinking and problem solving.
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.

Nice to have

Master's degree preferred.

Compensation

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 progr

Benefits

Maintain current knowledge of relevant issues related to data management, Health Authority regulations, and competitive trends to provide input and recommendations.

Company info

Xenon Pharmaceuticals (NASDAQ:XENE https://www.nasdaq.com/market-activity/stocks/xene) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics 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 product pipeline https://xenon-pharma.com/pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets. 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.
Xenon Pharmaceuticals (NASDAQ:XENE https://www.nasdaq.com/market-activity/stocks/xene) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics 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.
We are advancing an exciting product pipeline https://xenon-pharma.com/pipeline to address indications with high unmet medical need, including epilepsy, depression and pain.
Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications.
In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026.
Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication.
We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial.
In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting.
We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are important pain targets.
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.

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