Director/Assoc. Dir, Clinical Operations
Here at Tizona Therapeutics, we value Patients First!
With this goal in mind, Tizona develops next-generation immunotherapies.
The successful development of immunotherapies represents one of the most important and exciting breakthroughs in cancer. Despite the recent progress in the field of immuno-oncology, existing immunotherapies are only effective in a relatively small number of patients and types of cancer – a limitation that we hope to overcome.
Tizona’s therapies are designed to modulate the activity of immunosuppressive cells by targeting the cell types and biological mechanisms responsible for immune suppression in the tumor microenvironment.
General Position Overview:
This position is responsible for the strategy and execution of clinical operations to support of Tizona’s clinical programs. This role is accountable for the operational oversight and execution of assigned clinical trials including overseeing external partners such as CROs and clinical vendors to deliver on-time and on-budget quality clinical trial data. This role is responsible for ensuring operational excellence through developing and implementing processes, tools, and systems within Clinical Operations. This position is required to interact effectively with cross-functional team including clinical development (Medical Monitor, clinical scientist), biostats and programming, regulatory, medical writing, pharmacovigilance, CMC/drug supply, quality, program management, finance, legal contracts, translational sciences. In addition, the role will require proficiency in all aspects of trial management from RFP-vendor selection and oversight, study budget projections and oversight, start up and enrollment projections and execution, monitoring, development and oversight of study plans, data management, safety management, biosample management, quality management and delivery of clinical study reports. Thus, the role will require an understanding of the execution plans for clinical development including study designs and key study results such as the safety profile of investigational products, and an understanding of relevant oncology indications and key competitor data.
Essential Duties and Responsibilities:
- Facilitate team alignment to achieve clinical development goals as well as meeting corporate objectives.
- Support protocol(s) from start to final clinical study report including budgets, negotiation, payments, supervision of external organizations, site interaction, monitoring, data management, biostats, IRB interaction, central lab function, medical writing, pharmacovigilance, document prep (Investigator Brochures, FDA Briefing Documents, internal or external presentations.
- Contributes expertise in working with CROs and clinical study site personnel to ensure adherence to protocol, GCP, quality data and adherence to study timelines.
- Lead and manage staff and consultants in the design and implementation of Clinical Development Strategy and Operations initiatives and programs.
- Provide technical expertise for the development of clinical documents
- Establish and maintain productive working relationships within Tizona’s team, external partners including CROs, project leadership, finance and other relevant functions to optimize cross-functional communication; Recognize, leverage and connect interdependencies.
- Responsible for management of program budgets, forecasts for drug supply
- Lead the identification and communication of programs risks and mitigation strategies.
- Support Clinical Operational excellence activities including identification of continuous process and system improvement opportunities, supporting VP in ongoing needs assessments, and ensuring prioritization of activities.
- Development, tracking, execution and reporting of goals and objectives.
- Lead the development of assigned SOPs.
- Maintain awareness of major advances in oncology relevant to our compounds
- Understand and utilizes competitive intelligences
- Travel up to 20% may be required.
- Other Duties as assigned.
Education and Experience Requirements:
- BS/BA required; MS or higher degree in health-related field preferred.
- 10 years of relevant work experience with at least 7 years at biotech or pharmaceutical companies within Clinical Operations or related functions – preferably direct experience in >1 functional area.
- Prior experience in Oncology – solid and/or liquid tumors, Immuno-Oncology experience preferred
Management of Staff
- Will be responsible for managing direct reports and consultants as needed
Functional/Technical Knowledge & Skills
- In-depth knowledge of functional deliverables (across the Clinical Operations functions including Clinical Monitoring, Data Management, Clinical Science and Medical Writing) and a thorough understanding of the processes and resources required for accomplishing departmental objectives.
- In-depth proficiency in all aspects of trial management from RFP-vendor selection and oversight of performance metrics, study budget projections and oversight, start up and enrollment projections and execution, monitoring, development and oversight of study plans, data management, regulatory and safety reporting, biosample management, quality management and delivery of clinical study reports.
- Creative and innovative approaches for optimizing clinical operations and the skills and experience necessary to efficiently and effectively implement new approaches for achieving Tizona’s goals.
- Innovative and proactive approach to identifying potential issues and actions.
- Excellent strategic skills with the ability to influence decisions at a senior level, both internally and externally, and to communicate complex clinical issues in a scientifically sound and understandable way.
- Experienced in program level resource planning, planning and tracking to budget and timelines.
- Ability to successfully manage and prioritize multiple projects and demands simultaneously and to rapidly adjust to changing priorities and work effectively under pressure.
- Ability to think ahead and plan both short term and long-term goals for assigned programs. Ability to anticipate and solve practical problems and/or resolving issues.
- An understanding of clinical research methodology including the design and implementation of Phase 1 to 3 trials, process of data analyses, and regulatory submissions.
- Demonstrated ability to understand, evaluate, interpret and synthesize data.
- Extensive working knowledge of GCP, US IND and ICH regulations as they apply to Clinical Development activities and deliverables.
- Technical expertise to make a major impact; credibility required to influence; demonstrated ability to engender trust in others, to share knowledge and to involve others.
- Excellent verbal and written communication skills, including formal presentation skills are required.
- Ability to relate and work with a wide range of people to achieve results.
- Passionate about helping others achieve their maximum potential.
- Strong time management and organizational skills.
Tizona Therapeutics is an Equal Opportunity Employer. We value diversity and are committed to providing employees a workplace free of discrimination and harassment. All employment decisions are based on qualifications, merit and business needs.