A global organisation with outstanding products in the field of Immunology is presently looking to bring in a Senior Clinical Scientist to the group. The company has close to 2000 employees and with this, a strong pipeline of products.
This position will undertake global scientific responsibility for clinical programs and the position holder is responsible for scientific input to clinical development strategies, acting as the primary liaison between the assigned therapeutic area and also the key stakeholders to ensure translation of the development plan into operational deliverables.
- The successful candidate will have direct responsibility for the scientific oversight of clinical trials.
- Contributes to the scientific development of individual clinical studies in alignment with the approved clinical development plan. This includes authorship/ review of some clinical documents (protocols, CRFs, ICFs, CSRs, etc.) to ensure that the scientific content/ rigor is consistent and of the highest quality across the clinical development program.
- Contributes to the clinical oversight and medical guidance in collaboration with the Principal Clinical Scientist and (Senior) Global Clinical Program Director during the conduct of the study.
- May manage alone or in collaboration with clinical safety the operational functioning of data monitoring committees and/or clinical adjudication committees. May participate in and present at these meetings, as required. Manages the processes required to support external study review committees; e.g. steering committees
- Participate in the Clinical Operations and Clinical Development teams. Provide support to the clinical development team (CDT) through meeting management support and communication. Act as the delegate for the CDT lead where required.
- A proven scientific lead of a large Global Clinical Trial Industry specific
- Advanced degree (MD, PhD or PharmD) in life science/healthcare required with experience in clinical research. Bachelor degree or equivalent education/degree in life science/healthcare if accompanied with solid experience in clinical research.
- Experience with the operational aspects of clinical trials and related activities such as investigator meetings, DSMB's, and GCP/ICH are necessary.
- Excellent communication and presentation skills required.
For further information, please contact or email Darren Whyte on (646) 542 0158 or firstname.lastname@example.org