Director, Global Trial Lead
Bristol Myers Squibb
4 hours ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
Responsibilities:
- Lead and oversee multiple complex global clinical trials/programs; ensure high-quality data and regulatory compliance.
- Set trial execution vision; drive risk management and decision-making balancing cost, quality, scope, and timelines.
- Collaborate with internal teams and CRO/vendor partners to meet timelines, budgets, and quality benchmarks.
- Manage study budgets/contracts/SOW; conduct vendor selection/evaluation; set and monitor performance/quality metrics.
- Maintain study data in systems (e.g., Veeva CTMS/eTMF); establish study-level PM tools (action logs, risk plans, issue registers).
- Provide strategic guidance on feasibility, protocols, and execution; mentor teams and foster inclusive, high-performing culture.
- Provide lifecycle leadership (start-up to close-out) and coordinate cross-functionally (clinical, regulatory, development).
Qualifications & required skills:
- BA/BS required; advanced degree (MS/PharmD/PhD/MD or equivalent) preferred.
- 10+ years in clinical operations and global project management (pharma/healthcare), including multinational experience.
- Director-level experience leading global clinical trials/program strategy; lead global, multi-functional study teams.
- Advanced knowledge of clinical trial phases/therapeutic areas/regulatory requirements; ensure GCP/GXP compliance.
- Strong stakeholder/vendor management and influencing skills; critical thinking and decision-making in high-pressure environments.
- Use CTMS/clinical systems; familiarity with AI tools/tech advancements preferred.
Travel: up to 25%.
Benefits (explicitly listed): medical/pharmacy/dental/vision; 401(k), short- and long-term disability, life/accident insurance; PTO (flexible time off and holidays vary by location).
Application instructions: If not a perfect resume match, apply anyway.
- Lead and oversee multiple complex global clinical trials/programs; ensure high-quality data and regulatory compliance.
- Set trial execution vision; drive risk management and decision-making balancing cost, quality, scope, and timelines.
- Collaborate with internal teams and CRO/vendor partners to meet timelines, budgets, and quality benchmarks.
- Manage study budgets/contracts/SOW; conduct vendor selection/evaluation; set and monitor performance/quality metrics.
- Maintain study data in systems (e.g., Veeva CTMS/eTMF); establish study-level PM tools (action logs, risk plans, issue registers).
- Provide strategic guidance on feasibility, protocols, and execution; mentor teams and foster inclusive, high-performing culture.
- Provide lifecycle leadership (start-up to close-out) and coordinate cross-functionally (clinical, regulatory, development).
Qualifications & required skills:
- BA/BS required; advanced degree (MS/PharmD/PhD/MD or equivalent) preferred.
- 10+ years in clinical operations and global project management (pharma/healthcare), including multinational experience.
- Director-level experience leading global clinical trials/program strategy; lead global, multi-functional study teams.
- Advanced knowledge of clinical trial phases/therapeutic areas/regulatory requirements; ensure GCP/GXP compliance.
- Strong stakeholder/vendor management and influencing skills; critical thinking and decision-making in high-pressure environments.
- Use CTMS/clinical systems; familiarity with AI tools/tech advancements preferred.
Travel: up to 25%.
Benefits (explicitly listed): medical/pharmacy/dental/vision; 401(k), short- and long-term disability, life/accident insurance; PTO (flexible time off and holidays vary by location).
Application instructions: If not a perfect resume match, apply anyway.