Senior Manager, Data Management

Xenon Pharmaceuticals•Needham, MA

4d•Hybrid

About The Position

Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics. 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 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. 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 1-4). 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. This position reports to the Executive Director, Data Management and will be based out of Boston, MA, USA in our Needham office. Boston based positions require a minimum of two onsite days per week. We may consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience.

Requirements

Bachelor’s degree in a scientific, medical, computer science or related field; Master’s degree preferred.
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.
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 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.

Nice To Haves

Experience in CNS, pediatric rare disease area and e-diary database design and implementation are preferred.

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.
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 the 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.
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics.
Other duties as assigned.