Head of Clinical Development Operations

Head of Clinical Development Operations

Dragonfly Therapeutics seeks a knowledgeable, experienced, and motivated individual to join our team and lead clinical development operations. Reporting to the COO, 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 the company's Phase I-III clinical programs. The Head of Clinical Development Operations will oversee Biometrics and Clinical Operations to ensure that studies are completed on time and within budget in accordance with corporate objectives. The ideal candidate will have experience working in oncology and immunology clinical development from Phase I to Phase III, BLA filing, and be passionate about working in a fast-paced, biotech environment.

Responsibilities (including but not limited to):

• Develop 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
• Oversee 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 R&D leadership, clinical, regulatory, non-clinical, CMC, finance, legal and QA to build an integrated development plan that meets corporate goals
• Interface with R&D Leadership from Regulatory, Clinical Development and Clinical Safety to ensure that clinical operations activities are in line with overall product development goals. Participate in cross-functional meetings
• 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
• Oversee work with external vendors, IS/IT/Training platforms to develop clinical systems and tools that promote compliant, expedient data collection, analyses, reporting and deliverables
• 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)
• Participate in internal/external study-related audits, as required

Qualifications:

• BA/BS/MS and 10+ years directly related experience in clinical operations and trial management
• Experience working in immune-oncology clinical development is desired
• 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/BLA 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

About Dragonfly

Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.

Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.