Physician Scientist, Specialty Medicine, Clinical Development
211 Mount Airy Rd Basking Ridge, NJ 07920 US
Target Pay Rate: 100-150/hr **salary will be commensurate with experience
In this position, you will become a critical member of the clinical development team to progress the rare disease project being developed for the treatment of a rare ectopic calcification disease PXE.
In partnership with the global clinical leader, clinical operation lead, and in collaboration with external partners, you will serve as the Physician Scientist to lead the DS study team and the CRO operation team to successfully implement a project-critical Phase 2 trial. This critical path trial is designed to confirm the safety and tolerability and dose range finding in the target PXE population in preparation for a subsequent pivotal trial. Although straightforward in study design, the hybrid in-clinic-and-virtual trial conduct that integrates in-home nursing visit brings an exciting level of challenges and opportunities in this role. Specifically, you will work in close collaboration with the disease patient advocacy group and world-renowned PXE researchers. You will lead the DS and CRO teams to execute the study activities, manage regulatory and ethics committee interaction, serve as the DS medical monitor, expertly execute the study-end activities, and conduct data review and analysis. The major deliverables include but are not limited to strategic collaboration on study recruitment with the advocacy group, clinical trial investigator interactions, statistical analysis plan, study execution, medical monitoring, data analysis, and study reporting.
Beyond the roles and responsibilities in individual clinical trials, you will assist the global clinical leader and contribute to the progression of this global project. The opportunities in the key roles include clinical development strategy, regulatory interaction, key investigator/leader engagement, collaboration with patient advocacy groups, establishment and management of Scientific Advisory Board and Safety Monitoring Committee, while working closely with key members of the project team members, and external subject matter experts.
- Drug Dev Experience: Three years or more of hand-on experience in leading clinical studies and clinical development programs as a demonstrated leader from clinical/clinical development department in pharmaceutical or biotech companies
- Common sense. Strong written and verbal communication skills
- Ability to work and lead in cross-functional and cross-culture team settings
- Detail oriented yet think strategically to problem solve and drive progress
- Proactive, interactive, collaborative, and respectful
- Specific therapeutic area experience in rare disease in preferred but not required.
- MD in Internal medicine with 3 years of post-graduate internship and residency training in the US a must. Other medical specialty will be considered
**CO/NY candidates may not be considered
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