Boston, MA, USA ● Vancouver, BC, Canada
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.
We are seeking a Manager/Senior Manager, Data Management to join our team. 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 1-3). 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.
The position reports to the Director, Data Management and will be located in Vancouver, BC, Canada or Boston, MA, USA; we may consider other locations for an exceptional candidate.
- 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.
- Oversee external data management vendors in respect to key performance indicators, metrics, program level deliverables, timelines, and budgets; may participate in vendor selection activities.
- Optimize data management and collection activities by reviewing protocols for cross-trial consistency and identifying standard case report form modules.
- May support creation of SDTM datasets, which may include oversight of external vendors.
- Maintain current knowledge of relevant issues related to data management, Health Authority regulations, and competitive trends to provide input and recommendations.
- 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.
- 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.
- Bachelor’s degree in a scientific, medical, computer science or related field; Master’s degree preferred.
- A minimum of 4 years’ experience in a pharma or biotech environment.
- Strong experience in data management-related activities, with thorough understanding of clinical trials process and regulatory requirements, including CDISC requirement, specifically SDTM Mapping.
- 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.
- Experience in CRO management.
- Ability to be hands-on with database cleaning, generate patient level listings as needed.
- 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.
- Ability to travel up to 10%, both domestically and internationally.