We have a current opportunity for a Senior Clinical Scientist on a permanent basis. The position will be based in Berwyn. For further information about this position please apply.
The Senior Clinical Scientist is in charge of ensuring that assigned clinical studies are developed, carried out, and reported on with the utmost ethical, medical, and scientific rigor at all stages of drug development and commercialization. Responsible for the design, planning, start-up, and successful completion of assigned clinical trials for novel or commercially available medications during all stages of clinical development. Engages in dialogue with KOLs and other outside experts to guarantee a suitable and robust research design for a few indications.
Essential Duties & Responsibilities
- Contribute scientifically to clinical research.
- Write, edit, and review medical and scientific components of operational and regulatory documents for clinical research, including but not limited to synopses, protocols, CRFs, informed consent forms, feasibility analyses, statistical analysis plans, regulatory documents (such as IND, MAA, NDA, and PIP), key study plans, and clinical study reports to ensure accuracy, conformity with standard of care, logistical simplicity, and internal consistency.
- Verify the clinical research and regulatory documents' medical and scientific content for validity, accuracy, relevance, and completeness.
- Lead and delegate clinical data review tasks and data analysis to ensure data quality and consistency, including the identification of data and query trends to contribute to overall data quality. Lead responses to competent authority questions, as requested.
- Establish and maintain quality corporate relationships with leading investigators and clinical sites on assigned protocols in collaboration with Clinical Operations team.
- Contribute to the development of global regulatory strategies.
- Provides training and support to sites and CRAs at Investigator Meetings and other events as needed.
- PhD, PharmD or MD with demonstrated industry experience in clinical research and drug development, minimum 5 years preferred experience in the biopharmaceutical industry in clinical science, clinical research, or equivalent.
- Experience in AD and PD or neurodegenerative diseases.
- Proven track record of successful protocol development, execution, and reporting in industry.
- This organization offers a competitive salary, bonus structure and stock options
- Medical Dental and Vision
If you are interested in the Director of Clinical Development role please don't wait to apply!