Director of Clinical Operations

Director of Clinical Operations

Dragonfly Therapeutics is seeking a knowledgeable, experienced, and motivated individual to join our team and lead clinical development operations. Reporting to the VP Clinical Development Operations, this individual will be responsible for providing program oversight for multiple molecules in various stages of development. Job responsibilities include providing day to day support for clinical trial managers and clinical trial associates to ensure quality and on time and within budget delivery of milestones for studies and programs in alignment with the Corporate goals. The ideal candidate will have experience working in oncology clinical development from Phase I to Phase III, NDA/BLA filing, and be passionate about working in a fast-paced, biotech environment.

Responsibilities (including but not limited to):

• Contribute to the strategy for a highly efficient clinical operations group, including organizational structure and execution.
• Develop, implement, and update clinical operations SOPs and systems for clinical trials to standardize and support global adherence to company policies and procedures, cGCP and related regulatory processes.
• Oversee and manage all operational aspects of protocol design to database lock and report writing of Phase I-III global clinical trials to ensure clinical goals are met efficiently and with high quality.
• Review and approve as required, study documentation for clinical programs including protocols, statistical and data analysis plans, monitoring plans, informed consent forms, case report forms, investigator agreements and financial agreements.
• Support the selection and management of CRO vendors and service providers and build strong relationships with selected vendors.
• Oversee the CROs to avoid issues and/or rapidly adapt to challenges of feasibility/start up, slow recruitment, resourcing, site management, etc.
• Accountable for the establishment and effective operation of study management teams including support and collaboration with all functions to share information about the nature of studies being conducted as appropriate.
• Collaborate with cross functional team members in clinical, regulatory, non-clinical, CMC, finance, legal, program management and QA to develop an integrated program plan that meets corporate goals.
• Responsible for hiring, training, managing, coaching, mentoring, and performance management (including compliance) of clinical operations staff.
• Monitor study-specific timelines, key deliverables, and implement strategies to optimize the efficiency of trial conduct.
• Support data analyses and communication of clinical research results in accordance with applicable regulations, and in support of strategic business and/or regulatory goals.
• Accountable for setting up and maintaining an effective service provider model to ensure overall study commitments and provision of adequate resource in line with FTE demand projections (CPM/CRA/CTA) are met and that issues are escalated appropriately.
• Partner with external vendors, IS/IT/Training platforms to develop clinical systems and tools that promote compliant and efficient study management.
• Anticipate/identify potential problems and implement corrective actions as required for clinical study activities. Ensure audit readiness at all times (Sponsor and Investigational Study Sites).

Qualifications:

• BA/BS/MS and 15+ years directly related experience in clinical operations and trial management.
• Experience working in immune-oncology clinical development is required.
• 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 global 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/BLA regulations.
• Proven experience in managing & directing related functions such as 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.