Senior Director Clinical Operations
Are you looking for an established yet growing company? Are you a dynamic leader? Do you thrive in a role where you create from scratch and own your work?
Some things you will do in the role include:
- Lead and manage the assigned clinical operations team and have a key role in setting and executing departmental strategy in a remote-based biopharmaceutical company.
- Ensures the timely execution of clinical research programs/protocols from conception through final clinical study report predominantly using CROs. This will generally involve close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities.
- Maintains oversight of the conduct of the studies at the study centers (site selection, start up, monitor adherence to protocols and Good Clinical Practices (GCP), applicable guidance and study closure).
- Key contributor to the preparation and management of clinical study protocols and protocol amendments.
- Assists with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
- Contributes to the creation of internal SOPs & Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA & EMA regulations.
- Flexible and dynamic approach to working in a fast-paced biotechnology company; willing to perform all necessary tasks, regardless of level, to facilitate success at driving a project/program to completion.
Some things you will bring to the role:
- Bachelor's degree in health or science
- 10- 15 years of pharmaceutical or biotech-related/clinical research experience.
- Demonstrated experience in core and technical aspects of leading phase 1-4 clinical trials. Experience in neurology, psychology a plus.
- Proven success in managing clinical studies within timeline and budget.
- Demonstrated success in managing CROs to meet timeline, budget, and scope.
- Demonstrated managerial skills and strong interpersonal and communication (verbal and written) skills in interacting with clinical monitors, investigators, and various individuals in specialized areas or internal groups to facilitate translational, clinical, and correlative research.
- In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Outlook, and MS Windows
- Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm) and Safety/ Pharmacovigilance databases (ARGUS)
For immediate consideration, email LisaBarrett@scientificsearch.com and mention job#17736