Senior Manager, Global/Phase 3 Clinical Trial Operations
Xenon Pharmaceuticals · Boston
The role
Xenon Pharmaceuticals is hiring a Senior Manager to lead global Phase 3 clinical trial operations, from start-up through closeout. The role involves managing vendors, budgets, timelines, and cross-functional teams, and reports to the Director of Trial Operations. The position is hybrid, based in Needham, MA, with remote options for exceptional candidates.
- Location
- Boston
- Work mode
- Hybrid
- Employment
- Contractor
- Level
- Senior
- Experience
- 8+ yrs
- Education
- Bachelors
What we know that the posting doesn’t say
- Seen 2 days agostill listed on the employer’s careers page
- Posted 32 days agothe first time we saw it
About Xenon Pharmaceuticals
Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company developing treatments for epilepsy, depression, and pain, with a late-stage pipeline including the Phase 3 azetukalner program.
What you would do
- Lead management of multiple Phase 3 clinical trials across therapeutic areas
- Collaborate with cross-functional teams to create integrated trial plans and documents
- Develop and manage study plans, budgets, and timelines
- Lead RFP preparation, vendor selection, and CRO contracting
- Manage contracted service providers to ensure contract compliance
- Select qualified investigators and study sites with Clinical Development
Must have
- Bachelor's degree in scientific discipline or healthcare designation
- 5-8 years clinical project/study management experience in pharma/biotech/CRO
- Experience overseeing Phase 3 trial operations in related therapeutic areas
- Ability to lead cross-functional teams through full clinical study lifecycle
- Strong vendor management skills including CRO and outsourced work
- Understanding of drug development phases and interdependencies
- Specific experience in Phase 3 clinical trials
- Ability to manage multiple conflicting priorities
- Proven track record delivering clinical trials on time and within budget
- Strong knowledge of ICH/GCP and US/Canadian regulations
- Excellent oral and written communication skills
- Ability to travel 5-10% domestically and internationally
Nice to have
- Experience with CTA and IND submissions
- Comprehensive understanding of clinical trial regulations across multiple jurisdictions
What you get
- Base salary, target bonus, and stock options
- Medical, dental, and vision insurance
- Short- and long-term disability coverage
- Life insurance and AD&D programs
- Employee assistance and travel insurance
- Retirement savings with company matching
Experience and education
- 8+ years of relevant experience
- Bachelors degree or equivalent experience
Key skills
- clinical trial management
- vendor management
- cro management
- budget management
- timeline management
- risk assessment
- ich/gcp
- regulatory affairs
- protocol development
- site selection
- rfi/rfp
- project management
- cross-functional leadership
- mentoring
- standard operating procedures
Who We Are: 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 gre…
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