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About the role
- Senior Manager overseeing Phase 3 clinical trials at Xenon Pharmaceuticals, a neuroscience biopharmaceutical company. Leading vendors, sites, budgets, timelines, risk mitigation, and cross-functional trial execution.
Responsibilities
- Provide clinical trial management leadership for multiple Phase 3 clinical trials across therapeutic areas
- Collaborate with cross-functional team members to develop integrated clinical trial plans and documents
- Develop, propose, review, and manage plans for assigned studies and activities
- Lead RFP preparation, proposal evaluation, and CRO and clinical service provider selection and contracting
- Manage contracted service providers against contract deliverables
- Lead selection of qualified investigators and study sites
- Review and oversee study budgets and invoices
- Develop and manage study timelines and metrics
- Conduct risk assessments, mitigation strategies, and contingency planning
- Communicate with internal and external teams to identify and resolve challenges and risks
- Coordinate, write, review, and finalize clinical trial protocols, consent forms, case report forms, study plans, safety reviews, and regulatory documents
- Train and mentor new staff and support peer mentorship
- Share and implement trial conduct best practices and lessons learned
- Oversee adherence to regulations, guidelines, protocols, and clinical practice standards
- Participate in developing and updating standard operating procedures
- Act in accordance with company policies
- Perform other duties as assigned
Requirements
- Minimum bachelor’s degree in a scientific discipline and/or another healthcare designation such as RN
- Minimum 5–8 years of clinical project/study management experience in pharmaceutical, biotechnology, biopharmaceutical, or CRO settings
- Proven experience overseeing and rolling out Phase 3 studies in related therapeutic areas
- Ability to lead cross-functional teams through the full clinical study life cycle
- Strong vendor management skills, including CRO management and outsourced work
- Understanding of all phases of drug development and interdependencies among Clinical, CMC, nonclinical/toxicology, Regulatory Affairs, and other functions
- Specific Phase 3 clinical trial experience
- Ability to work across teams and manage conflicting priorities
- Ability to manage and deliver critical clinical trial milestones on time and within budget
- Strong knowledge of ICH/GCP and U.S. and Canadian regulatory environments
- Comprehensive understanding of clinical trial regulations across multiple jurisdictions
- Previous CTA and IND submission experience preferred
- Excellent oral and written communication skills
- Strong interpersonal and collaborative relationship-building skills
- Ability to work independently and collaboratively in a multidisciplinary team
- Exceptional attention to detail and organizational skills
- Ability to thrive in a dynamic, fast-paced environment
- Ability to prioritize duties, manage multiple matters from start to finish with minimal supervision, lead change, and make independent decisions
- Ability to handle highly confidential and sensitive materials with complete discretion
- Ability and willingness to travel 5–10% internationally and domestically
Benefits
- Base salary
- Target bonus
- Stock options
- Medical insurance
- Dental insurance
- Vision insurance
- Short-term disability insurance
- Long-term disability insurance
- Accidental death & dismemberment insurance
- Life insurance
- Employee Assistance Program
- Travel insurance
- Retirement savings programs with company matching contributions
- Vacation
- Personal days
- Sick days
- End-of-year company shutdown
- Employee development opportunities
- Training, Learning & Development program
- Tuition Assistance program for advanced degrees
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