Senior Director, Clinical Operations
Cyteir is seeking an experienced and motivated professional to build and lead our clinical operations function as a key member of our growing development team. This individual will be responsible for developing the strategy for the clinical operations department build, for implementing best-in-class and efficient clinical trial processes, and for initiating and managing the conduct of our phase I-III clinical programs. The Senior Director of Clinical Operations will ensure that studies are completed on time and within budget in accordance with corporate objectives. The ideal candidate will have experience in hematology/oncology and/or auto-immune clinical development from phase I to phase III, in NDA/BLA filing, and in working in a fast-paced, start-up biotech environment.
- Develop the strategy to build a highly efficient clinical operations group, including hiring plan, then execute the plan.
- Develop GCP compliant processes and implement SOPs and systems for clinical trials.
- Oversee and manage all operational aspects from protocol design to data base lock and report writing of phase I-III global clinical trials to ensure clinical goals are met efficiently and with high quality.
- Oversee the selection and management of CRO vendors and service providers and build strong relationships with selected vendors.
- Collaborate with R&D leadership, clinical, molecular diagnostics, regulatory, non-clinical, CMC, finance, legal and QA to build an integrated development plan that meets corporate goals.
- Monitor study-specific timelines, key deliverables, and implement strategies to optimize the efficiency of trial conduct.
- Provide oversight of the CROs to avoid issues or rapidly adapt to challenges of feasibility/start up, slow recruitment, resourcing, site management, etc.
- Strategically assess and recommend third party vendors for implementation of trials. Establish requests for proposals, negotiate and approve contracts and work orders, and review invoices prior to submission to senior management for approval.
- Responsible for hiring, training, managing, coaching, mentoring, and performance management (including compliance) of clinical operations staff in a matrix environment
- BA/BS/MS and 10+ years directly related experience in clinical operations and trial management.
- Experience starting up and managing trials in hematology/oncology required. Auto-immune diseases or rare diseases a plus.
- In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget.
- Experience working in a fast-paced biotech environment.
- Experience interacting and managing with regulatory and ethics authority submissions.
- Experience with regulatory audits and inspections
- In depth understanding of GCP regulations and knowledge of other regulatory guidelines (GLP and GMP).
- Full phase life cycle experience a plus.
- Understanding of IND & NDA regulations.
- Proven experience in managing & directing related functions such as data management & operations, CRO vendor management including diagnostic vendors, procurement & contracting etc.
- Proven track record of leadership and operational excellence required.
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
- Excellent communications skills and ability to influence across multiple functions
The Senior Director of Clinical Operations will be an energetic and team-oriented professional with a history of accomplishment managing clinical trials. He or she will have the interpersonal skills required to collaborate and communicate effectively with a first-rate scientific team, playing a critical role in the clinical development of exciting new therapies in the treatment of cancer.