South San Francisco California, RTP North Carolina or remote
Satsuma Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing STS101 (dihydroergotamine mesylate (DHE) nasal powder) as an important and differentiated therapeutic option for the acute treatment of migraine.
Satsuma’s lead product, STS101, is a novel and proprietary investigational drug-device combination product specifically designed to enable intranasal administration of the anti-migraine drug DHE, with a pharmacokinetic profile designed to provide reliable, robust and consistent clinical performance in the acute treatment of migraine. In developing STS101, Satsuma has applied proprietary nasal drug delivery device, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be quickly and easily self-administered in matter of seconds.
Phase 1 and 3 study data indicates that the product is well tolerated, reaches therapeutic plasma concentrations and shows meaningful effects in migraine subjects when used during a migraine attack.
The Senior Director, Clinical Operations will report to the Vice President Clinical Operations and will work with the VP to ensure that clinical strategies and study protocols are translated into operational plans for assigned studies. The Senior Director, Clinical Operations works closely with all members of the Clinical Operations teams and with all other functions, for example drug manufacturing, regulatory and quality assurance. The Senior Director, Clinical Operations is involved with the selection and oversight of the Clinical Operations vendors.
Duties and responsibilities:
- Act as the Clinical Operations team representative on assigned programs and will collaborate with all functions and vendors per the agreed upon timelines and budget.
- Provides input into study protocols, clinical study reports, and other clinical documents as appropriate on assigned studies. Contribute to the development of the Master Informed consent for assigned studies.
- Contribute to the Clinical Operations plans and budgets and update timelines and budgets of the clinical development programs in collaboration with the VP Clinical Operations, and other relevant functions on assigned studies.
- Involved in internal process improvement activities such as SOPs or guidance documents, as assigned.
Behaviors / skills:
- Good organizational skills and ability to manage multiple studies
- Good communication skills, both verbally and in writing
- Good presentation skills
- Ability to work across locations and time zones
- Ability to prioritize tasks
- Ability to work both within and across different teams
- Good teamwork skills
- Strong interpersonal skills and ability to manage multiple vendors
- Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas
- Able to travel, for at least 20% of time, depending on business needs.
Education & experience:
- Health or Biologics Science degree required; BS or MS preferred
- 10+ years of experience in clinical development operations with at least 5 years in a study management capacity
- 5 years CRA Monitoring Experience (Minimum)
- Experience managing Phase II/III studies is required
- Experience managing Phase I-III studies strongly preferred
- Previous experience at a sponsor/pharmaceutical company is strongly preferred
- Previous experience with vendor management of a CRO is strongly preferred
For additional information:
Please send your resume or CV to us at email@example.com
A competitive compensation package comprising of base salary, annual bonus and stock options will be offered.