Head of Clinical Operations (Senior Director/Director)

Position Summary

The Head of Clinical Operations is a senior leader accountable for the overall strategic direction and management of the clinical operations, strategic outsourcing and data management functions. This individual will oversee program level execution of all clinical plans in all phases of development and represent the aforementioned functions up to the Executive Committee. This position can be at the Director or Senior Director level, dependent on expertise, and will report to the Chief Medical Officer.

Essential Functions

These may include, but are not limited to, the following:

  • Accountable for driving and leading the clinical operations, strategic outsourcing and data management functions in the operational aspects of all clinical programs in accordance with Immune-Onc Therapeutics’ values.

  • Actively contributes to project teams, partnering closely with other functional area representatives to plan and execute high quality, efficient and innovative clinical programs.

  • Translates corporate and project team goals into relevant, tangible and measurable objectives for the operational team and third-party vendors, and drives optimal delivery.

  • Accountable for proposals, selection, contracts and oversight of all relevant external vendors, including study sites and CROs, to ensure high quality performance in support of clinical programs.

  • Owns clinical operations budget and provides forecasts and monitoring of budgets, headcount, and resources across all clinical programs for near term and long-range planning; develops accurate assumptions and prudent allocation of resources.

  • Establish, monitor and report on high performance standards and metrics for the execution of all clinical trials and related activities.

  • Update Senior Management with progress and facilitate timely escalation of anticipated changes in scope, schedule, budget and resources.

  • Responsible for partnering with technical development (CMC) to coordinate the investigational medicinal product supply chain including forecasts, labeling, packaging and distribution.

  • Oversees data collection activities for all clinical programs. Ensures quality data are available to support annual reports, investigator brochure, regulatory filing of safety summaries and project metrics summaries, etc.

  • Build and lead a world-class clinical operations team. Accountable for training and management of clinical operations teams with direct reports who may include both internal staff and consultants. Ensure optimal workforce planning, retention, coaching consistent with company’s overall human resource growth strategy, and performance management of the staff. Mentor and manage the growth and development of direct reports.

  • Provide training, direction and mentorship to clinical operations staff to achieve all milestones and deliverables of all clinical trials, including timely initiation, enrollment targets, high quality study data, data cleaning, database lock, and clinical study report drafting and finalization.

  • Ensures that clinical activities are conducted in compliance with cGCP standards and that adherence to company and/or CRO SOPs, FDA/EMA regulations, ICH guidance, and study protocols is maintained such that all trials are “audit ready” at all times.

  • Identify program risks; proactively create and implement mitigation strategies.

  • Leads optimization and implementation of the standard operating procedures, work instructions, templates, processes, communication, and infrastructure within clinical operations.

Experience

  • 10+ years of experience of direct applicable clinical drug development including personnel management (at least 5 years as a clinical study lead). Hematology/Oncology experience and start-up biopharma experience preferred.

  • Thorough understanding of the processes associated with executing a clinical development program including: clinical trial design, implementation, management and reporting.

  • Experience in the execution of complex clinical trials, ranging from Phase 1-3 studies, single and multi-center, US and global programs.

  • Strong working knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.

  • 3+ years of direct line management with experience in building and managing a diverse group.

Education

  • BS/BA/MS degree in a scientific discipline and/or RN license required.

Additional Skills

  • Proactive and able to flex and adapt in a fast-pace, dynamic environment.

  • Expertise in project management, critical path construction and analysis.

  • Understanding of financial principles, budget management and staff utilization.

  • Outstanding communication skills with the ability to distill complex issues and ideas down to simple, comprehensible terms.

  • Proven ability to foster team productivity, cohesiveness, and collaboration.

  • Ability to balance competing interests of various stakeholders and strive for achieving mutually beneficial and compliant solutions.

  • Committed to Immune-Onc Therapeutics’ values.

  • Current US work authorization required.

  • Ability to travel domestically and internationally, up to 20%.

A Snapshot of Immune-Onc

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients. The company aims to translate unique scientific insights in the tumor microenvironment and immune suppressive pathways to develop first-in-class biotherapeutics. Immune-Onc has a promising pipeline built upon strategic collaborations and cutting-edge research from leading academic institutions.

We pride ourselves on creating an environment that is scientifically driven, supportive, and collaborative. We encourage the diversity of thought that leads to great innovation and seek the best and brightest talent to join our dynamic team.