About This Role
An Associate Clinical Research Director in immunohematology provides medical expertise and support to the clinical lead for clinical studies related to the Sickle Cell Disease development program. This role involves serving as a key medical expert within cross-functional teams, supporting the design, planning, execution, and interpretation of clinical studies while ensuring scientific rigor, medical relevance, and patient safety.
Responsibilities
- Provide medical expertise and/or support to the clinical lead for clinical studies (immunohematology Sickle cell disease development program)
- Support other clinical development activities (e.g., pre-assessment and cluster feasibility, medical review and validation of clinical data, study risk assessment and clinical study sites engagement)
- Contribute to the Extended synopsis and Protocol for their project
- Provide appropriate medical input and support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
- Support the study CRD as the medical reference in the Clinical Study team, ensuring the medical relevance of clinical data
- Interact with Clinical Leads and other CRDs from the team
- Contribute to drug product development strategy and oversee implementation and execution of drug product development until product approval by health authorities
- Contribute and lead medical operations across the lifecycle of R&D clinical studies or programs (i.e., protocol development, set-up, start-up, conduct, closure, and publication) with the objective of efficiently delivering high quality, cost-effective, conclusive studies, through close collaboration with internal and external stakeholders and clinical studies PIs
Requirements
- Medical degree (MD) or MD/PhD required
- Specialty training in a relevant medical discipline required
- Hematology training and/or clinical experience is highly preferred but not required
- Clinical expertise and experience in Sickle Cell Disease or related hematologic disorders strongly preferred
- Minimum of 3 years of relevant experience in clinical research, clinical development, academia, healthcare, biotechnology, pharmaceutical industry, regulatory agencies, or a related environment
- Solid understanding of clinical development and drug development processes, including protocol development, study conduct, and clinical data interpretation
- Ability to interpret complex scientific, clinical, and disease pathway data and translate findings into clinical development insights and strategies
- Working knowledge of Good Clinical Practice (GCP), clinical research methodology, and applicable regulatory requirements
