Role Summary
Director/Senior Director of Clinical Science focused on oncology and immuno-oncology. Lead innovative clinical development strategies, ensure safety and efficacy of investigational drugs, and drive global clinical studies while improving clinical data processes. Collaborate with cross-functional teams to advance trials in a forward-thinking environment.
Responsibilities
- Design cutting-edge clinical trials in collaboration with Clinical Development Leads to evaluate investigational drugs’ safety and efficacy, including protocols, patient populations, and study endpoints.
- Ensure medical oversight of clinical trials, monitoring study progress, reviewing data, and managing adverse events in alignment with regulatory and ethical standards.
- Lead or contribute to creating essential documents such as study protocols, Investigator’s Brochures, regulatory submissions, and safety updates.
- Drive strategic alignment within Clinical Development by promoting best practices and enhancing cross-functional processes.
- Provide leadership for the Clinical Science team through talent acquisition, onboarding, training, performance management, and workforce planning.
- Collaborate across departments—clinical operations, biostatistics, regulatory affairs—to ensure successful execution of clinical programs.
Qualifications
- Bachelor’s degree in life sciences or healthcare; advanced degrees preferred.
- Extensive knowledge of Good Clinical Practice (GCP) guidelines and drug development processes across Phases 1–3; expertise in oncology/immuno-oncology highly desirable.
- Proven experience leading global clinical studies within pharmaceutical companies or CROs.
- Advanced skills in data management systems (e.g., EDC systems) with a focus on optimizing processes for continuous improvement.
- Strong ability to work effectively in matrixed environments while influencing stakeholders without direct authority.
- Exceptional adaptability under tight deadlines combined with high organizational skills to prioritize tasks effectively.
- Excellent verbal and written communication skills in English.