Clinical Project Manager
Emmecell is a clinical-stage biotechnology startup that received IND approval to commence a multicenter Phase 1 clinical study for lead product EO2002, a magnetic cell therapy to treat corneal edema.
We are looking for a self-starter, experienced clinical project manager to execute all launching activities and manage day-to-day clinical operations through the subsequent study milestones in a dynamic and growing environment. In addition, the candidate will be responsible for a timely trial execution and ensuring the quality of the results. Other responsibilities include (but are not limited to) authoring all regulatory documents and clinical communications as needed (IRB/IEC, FDA, CRFs, SOPs, publications, etc.), and assisting with data analysis and communicating to relevant stakeholders on behalf of the company.
Required Education, Skills, and Experience:
- Bachelor's degree with 5+ years of experience and successful execution of Phase 1-2 clinical trials. An advanced degree in a health-related field and a similar experience are preferred.
- 3+ years of experience in a biotechnology company environment
- Experience in Ophthalmology and/or cell therapies are preferred.
- Experience and knowledge of ICH/GCP, global, federal, and local regulations.
- Proven experience designing, planning, managing, and monitoring early-phase clinical studies.
- Proven experience developing early-stage clinical protocols and authoring regulatory submissions.
- Project management and organizational skills. Attention to detail.
- Excellent verbal, communication and interpersonal skills are a must.
- Fluent in English
- Proficiency in Microsoft Office and Adobe suite for charts, tables, forms, reports, and presentations. Programming skills preferred but not required.
- Domestic and international travel may be required (~30%). This position can be remote.
To apply, please send your CV and a cover letter with references.
Emmecell is an equal opportunity employer committed to non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, gender identity, pregnancy, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest; however, only those selected will be invited for an interview.