Program Lead, Clinical Delivery - FSP
New
J
JobgetherPharmaceutical clinical development
Based in BrazilFull-TimeLead
Salary not disclosed
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Job Details
- Experience
- At least 3 years of pharmaceutical industry experience with direct responsibility for managing clinical studies is required, with 5+ years preferred.
- Required Skills
- Microsoft ExcelBudget managementRisk Management
Requirements
- Bachelor’s degree in a science-related field from an accredited college or university; an advanced scientific degree is an advantage.
- At least 3 years of pharmaceutical industry experience with direct responsibility for managing clinical studies; 5+ years is preferred.
- Exploratory and biopharmaceutics clinical development experience is preferred.
- Knowledge of regulations and guidelines governing clinical trials, clinical development operations, and submission requirements.
- Experience using clinical project management processes and tools, with the ability to manage complex timelines, budgets, vendors, and stakeholder groups.
- Experience overseeing third-party organizations and vendors and building working relationships across functions, geographies, and cultures.
- Ability to identify root causes, implement corrective actions, and develop risk mitigation and contingency strategies.
- Leadership, influencing, negotiation, problem-solving, and interpersonal skills for working in a matrixed and virtual environment.
- Strong written and verbal communication skills for presenting information to teams, stakeholders, governance groups, and senior leadership.
- Computer proficiency with Microsoft Word, Excel, PowerPoint, and Microsoft Project.
- Vendor management, contracting, coaching, and mentoring experience is preferred.
- Ability and willingness to travel up to 10% as required.
Responsibilities
- Lead the creation and execution of clinical asset strategies and Phase 1 development plans.
- Provide scientific and operational input into clinical and regulatory documentation.
- Lead clinical project management processes, tools, timelines, and process maps, and communicate progress, milestones, risks, and decisions.
- Oversee global clinical trial operations from planning through execution, including timelines, vendor selection and management, outsourcing plans, deliverables, and budgets.
- Partner with financial, regulatory, medical, cross-functional, and regional teams on budgets, safety and monitoring processes, project changes, and operational priorities.
- Identify clinical risks, root causes, and delivery challenges, and develop mitigation and contingency plans.
- Build partnerships and lead communication across clinical teams, governance forums, leadership, affiliates, and external stakeholders.
- Coach colleagues and support the development of clinical capabilities; where applicable, recruit and develop teams and manage workload and resources.
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