In conjunction with internal medical staff and external consultants including CMO, serves as the primary operational leader for designated clinical trials. Lead and coordinate the development of novel therapeutics from first-in-human to proof of concept studies. Key member of the study team and ensures seamless connectivity between Calibr and its vendors that include contract research organizations and others.
* Interacts with and advises clinical CROs as appropriate. * Liaises with both internal and consultant clinical operations personnel and other corporate personnel including executive and non-executive staff. * Interacts as needed/requested with clinical sites and clinical investigators investigator brochure, informed consent and annual reports. * Leads the preparation of clinical protocols and leads or assists in the preparation of other clinical documents such as the investigator brochure, informed consent and annual reports. * Responsible for execution of clinical studies, delivering on high quality trials, assessments and clinical study results. * Liaises with the appropriate team members of the CRO and with clinical site personnel to ensure issues are identified early and addressed and serves as a technical resource for the studies. In conjunction with other team members, responsible for on time execution and delivery of milestones for the clinical studies.
San Diego, California
This position works in a typical office environment. With or without reasonable accommodation, employees in this position must be able to sit and type at a computer terminal for up to 8 hours per day with appropriate breaks and perform tasks that require fine dexterity and repetitive motions using the arms, hands, wrists and fingers. Further details of the physical requirements of established essential functions for this position will be addressed/discussed during the interview process.
PhD in related scientific field.
Prior clinical experience in Oncology or related field.
5-10 years direct experience in the pharmaceutical industry, preferably in a clinical scientist role.
Understanding of drug safety regulations and processes and clinical trial oversight.
Experience providing input into key regulatory documentation.
Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders.
Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.
Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities.
Job Closing Date:
Open Until Filled
Job Posting Category
Scientific & Technical
The Scripps Research Institute is an Equal Opportunity Employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic or status.
Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!