Associate Director/Director, Clinical Science
With this goal in mind, Tizona develops next-generation immunotherapies.
General Position Overview:
The Associate Director/Director, Clinical Science will provide clinical and scientific support in all aspects of the clinical development program, including the design, preparation, conduct, monitoring, analyses, and reporting of the studies. The successful candidate will be a member of a cross-functional team, ensuring that clinical and scientific issues are considered in developing and executing individual clinical studies. The Associate Director/Director, Clinical Science will be involved in operationalizing studies, including the adjudication process, monitoring data, medical review, oversight of data management and data analysis.
Key Accountabilities/Core Job Responsibilities:
- Participate in the development of clinical protocols and amendments, investigator brochures, and clinical study reports
- Partner with Clinical Operations and Data Management on clinical trial conduct and data monitoring, including GCP, patient eligibility, and monitoring of study data
- Reviews clinical data listings, patient profiles, and summaries to ensure data collection proceeds consistently with the protocol and strategic objectives
- Support the development of clinical sections for regulatory correspondence and submissions including but not limited to Information Requests, Briefing Books, and presentation materials, and INDs.
- Supports clinical studies conduct, including clinical monitoring activities, Data Safety Monitoring, or Steering Committee meetings as applicable
- Conducts literature reviews to support clinical development programs and regulatory submissions
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into the clinical trial development strategy
- Work and partner with internal and external (CRO, investigator) stakeholders
Education and Experience Requirements:
- PharmD, Ph.D., or advanced clinical degree (i.e., Nurse Practitioner) required
- At least 5-7 years of experience in clinical research and development required
- Prior experience in biotechnology or pharmaceutical industries
- The successful candidate must be a skilled relationship developer, employ an entrepreneurial spirit, and passionately embody the Tizona’s mission to develop first in-class immunotherapies
- Science focused on interest in data and endpoints
- Previous experience with clinical trials and knowledge of Good Clinical Practices, regulatory requirements for the conduct of clinical trials
- Good project management skills and the ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
- Ability to work collaboratively with the internal partners of Tizona and ability to build relationships with clinical sites and outside vendors
- The ability to work under pressure to meet deadlines, the ability to handle complex projects and to overcome delays and obstacles, and excellent team member and interpersonal skills are required
- Previous experience with adjudication of clinical events in trials is a plus
- Teams in a matrix management organization with familiarity in critical clinical research tasks including protocol authorship and trial execution
- Attention to details, able to proactively identify issues and propose solutions
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.