Clinical Operations Leader
Sanofi
5 months ago
Remote friendly (Swiftwater, PA)
United States
Operations
Main Responsibilities
- Lead and coordinate clinical project operational activities, ensuring deliverables are on time, within budget, and to the highest quality standards.
- Develop and drive the planning of the Clinical Development Plan (including regulatory submissions) and ensure alignment across the extended clinical team and R&D project team.
- Act as the key liaison between clinical platforms and enabling functions (Global Regulatory Affairs, Pharmacovigilance, Finance, Medical, Global Immunology) to resolve issues and maintain effective cross-functional communication.
- Monitor project progress against strategic objectives and key performance indicators, proactively escalating risks and issues to clinical management.
- Lead risk management and crisis coordination within the clinical project, facilitating issue resolution and implementing action plans.
- Consolidate and manage the clinical project budget, working with Business Office, Functional Planners, and R&D Finance to ensure accuracy and efficiency.
- Foster continuous improvement and innovation by championing digital methodologies, new clinical trial designs, and lessons-learned approaches within the project team.
About You (Qualifications)
- Experience: 8+ years of pharmaceutical industry experience with strong clinical operations and project management experience; proven track record leading multifunctional teams in a global environment.
- Skills: exceptional project management, strategic leadership, and verbal/written communication; strong business acumen; ability to drive high-performing cross-functional teams; proactive decision-making; innovative problem-solving; conflict resolution and negotiation; culturally aware and adaptable.
- Education: Master’s degree in Life Sciences, Medical Sciences, Pharmaceutical Sciences, Health Sciences, or related scientific/medical discipline.
- Familiarity with project management software and digital tools.
Benefits (explicitly mentioned)
- Flexible working options and comprehensive healthcare.
- Structured career paths designed for scientific and leadership advancement.
Location
- Swiftwater, PA
- Lead and coordinate clinical project operational activities, ensuring deliverables are on time, within budget, and to the highest quality standards.
- Develop and drive the planning of the Clinical Development Plan (including regulatory submissions) and ensure alignment across the extended clinical team and R&D project team.
- Act as the key liaison between clinical platforms and enabling functions (Global Regulatory Affairs, Pharmacovigilance, Finance, Medical, Global Immunology) to resolve issues and maintain effective cross-functional communication.
- Monitor project progress against strategic objectives and key performance indicators, proactively escalating risks and issues to clinical management.
- Lead risk management and crisis coordination within the clinical project, facilitating issue resolution and implementing action plans.
- Consolidate and manage the clinical project budget, working with Business Office, Functional Planners, and R&D Finance to ensure accuracy and efficiency.
- Foster continuous improvement and innovation by championing digital methodologies, new clinical trial designs, and lessons-learned approaches within the project team.
About You (Qualifications)
- Experience: 8+ years of pharmaceutical industry experience with strong clinical operations and project management experience; proven track record leading multifunctional teams in a global environment.
- Skills: exceptional project management, strategic leadership, and verbal/written communication; strong business acumen; ability to drive high-performing cross-functional teams; proactive decision-making; innovative problem-solving; conflict resolution and negotiation; culturally aware and adaptable.
- Education: Master’s degree in Life Sciences, Medical Sciences, Pharmaceutical Sciences, Health Sciences, or related scientific/medical discipline.
- Familiarity with project management software and digital tools.
Benefits (explicitly mentioned)
- Flexible working options and comprehensive healthcare.
- Structured career paths designed for scientific and leadership advancement.
Location
- Swiftwater, PA