Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking an exceptional Clinical Operations leader to join its growing team. The successful candidate will be responsible for the strategy and execution of clinical trials and all clinical operations in support of the development of all Semma’s clinical programs. This position reports to the Chief Medical Officer, and is located in Cambridge, MA.
- Strategically build and lead the planning, resourcing, and management of high quality clinical trials on time, and within budget that will ultimately lead to regulatory approvals
- Provide oversight for the participation and evaluation of development strategy feasibility for full life cycle of studies
- Create strategy and manage the CRO vendor partnership
- Lead teams to optimize coordination of cross functional team(s) comprised of colleagues from Clinical Development, CMC, Project Management, Cell Biology, Delivery, Finance and external collaborations as determined by the needs of the team
- Effectively communicate timelines and relevant updates to management, all team members and ancillary parties involved in the successful execution of program(s)
- Ensure quality, compliance and efficiency by optimizing processes, identifying and implementing best practices and knowledge sharing
- Oversee the preparation and completion of clinical study protocols, CRFs and other study related materials for all assigned clinical programs
- Oversee the data collection activities for all assigned clinical programs. Ensure quality data is available to support annual reports, investigator brochures, regulatory filings, safety summaries, project team summaries, etc.
- In-depth knowledge of ICH/GCP guidelines and FDA regulations and drug development processes
- Prior management/supervisory experience and significant expertise in the oversight of clinical trials
- Ability to work on problems of diverse scope and extremely complex in nature which may cross many functional areas
- College degree with minimum of 10 years of relevant experience in clinical operations experience or equivalent experience in the pharmaceutical/clinical research environment with cross-functional operational execution
- Lead in a manner that creates a motivated, committed and engaged clinical development operations teams, internal and external, including data management, pharmacovigilance, statistical programming, clinical compliance and medical writing.
- Proven ability to function effectively across a matrix organization with multiple stakeholders
- Experience in clinical development of cellular therapies
- Demonstrated experience in successfully leading teams in an effective, efficient manner
- Direct experience in preparation of regulatory submissions, presentation to regulatory advisory panels in support of registration of a new drug
Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.