Job Title: Senior Director, Clinical Operations
Job Number: 21483
Location: Cambridge, MA
The Head of Clinical Operations will be responsible for developing the global clinical development strategy and execution of clinical trials for all of Casebia’s clinical programs across multiple therapeutic indications. All therapeutic areas will leverage Casebia’s technology in CRISPR genome editing, cell therapy, and advanced delivery modalities such as lipid nanoparticles and adeno-associated viruses. This role will build and oversee the Clinical Operations team to ensure all assigned operational trial deliverables across programs are completed according to timelines budget, operational procedures, quality standards, SOPs and business guidelines. This individual will need expertise in successful planning, implementation, and delivery of clinical operations strategy, plans and study execution. This individual will also be responsible for managing and supporting vendor/CRO relationships and activities including negotiations and performance evaluations. Reporting into the Chief Medical Officer, the successful candidate will be working closely with all discovery, CMC, clinical development, project management, and regulatory functions to enable successful advancement of Casebia’s assets into the clinic and through licensure.
The successful candidate will be a confident and respected leader with significant prior industry success in driving clinical operations function to meet its objectives, likely with deep experience in rare diseases and advanced therapeutic modalities such as gene and cell therapy. The successful candidate will have demonstrated the ability to lead clinical development programs globally across different regulatory regions. S/he is also expected to be an outward facing leader of the company interacting with investigators, trial sites staff, CROs staff, and key opinion leaders. S/he also must have a successful track record building and developing clinical operations teams and propelling them towards excellence. We are seeking someone with a sense of urgency for developing new therapies for devastating diseases and who is interested in forging new and uncharted paths for patients using the exciting CRISPR genome editing technology. S/he is expected to model and inspire a strong collaborative and can-do attitude across the different functions of the company, including serving as an individual team member.
- Provide strategic and technical guidance to, and manage CRO/vendor clinical operations resources for the execution of clinical stage programs
- Provide oversight for the participation and evaluation of development strategy feasibility for full life cycle of studies
- Drive creation of clinical operations standards, systems, and processes across the clinical stage programs
- Build a clinical operations team and communicate with external vendors in the Clinical Operations function, and provide management and guidance across the function
- Plan for and prioritize activities and resources, in line with the clinical development strategy for each program
- Ensure that external vendors are selected and managed to deliver within established timelines and financial investment
- Create strategy and manage the CRO vendor partnerships
- 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.
- Oversee and manage other vendors/contractors/consultants for biostatistics, data management, and pharmacovigilance
The successful candidate we hire will be an accomplished leader who is passionate, driven, and biased for action. S/he will have the following mix of personal and professional characteristics:
- Bachelor’s degree with 10+ years of relevant experience in clinical operations or equivalent experience in the pharmaceutical/clinical research environment with cross-functional operational execution
- In-depth understanding and working 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
- Proven ability to lead in a manner that creates a motivated, committed and engaged clinical development operations teams, internal and external, including data management, pharmacovigilance, statistical programming, and clinical compliance.
- Proven ability to communicate and function effectively across a matrix organization with multiple stakeholders
- Experience in clinical development of cellular and gene therapies is preferred
- Direct experience in preparation of regulatory submissions, presentation to regulatory advisory panels in support of registration of a new drug
- Experience in collaborating in developing global clinical development strategy and execution of these in multiple therapeutic areas
- Proven ability to prioritize, meet deadlines, and manage competing priorities and changing demands
- Skill required to create buy-in from functional groups and departments
- Outstanding communication skills; comfortable representing the company and vision to internal and external stakeholders
- Confident, independent and decisive; a self-starter, proactive and results-oriented with high performance standards. Passionate, persistent and tenacious. Strong ability to prioritize and operate with a sense of urgency.
- “Hands-on”, “roll-up-the-sleeves” leader who understands the need for involvement at all levels of activity within a small company environment. Extremely bright with a highly strategic nature but also balanced with a biotech mindset and an attitude that gets things done.
- Willingness to travel (domestic/international, approximately 20-30% time) to meet investigators, attend conferences, and participate in advisory boards.