Sr. Director/Executive Director, Clinical Development
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.
We are seeking for a Sr. Director/Executive Director for Clinical Development to oversee the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. This individual will work with the Chief Medical Officer to formulate strategic portfolio development across programs and within individual programs as appropriate which may include evaluation of agents for potential collaboration. This individual will be responsible for providing input used for the design of clinical study concepts and writing of clinical trial protocols, IBs, CSRs, and scientific presentations to the highest scientific standards. Based on experience, this individual will also be the primary Medical Monitor for all clinical studies conducted under his/her responsibility, and contribute to/provide medical review, analysis, and interpretation of data from clinical studies.
Key Job Responsibilities:
- Establishes and communicates clinical trial strategies for high-quality early clinical decision making directed at highest value labels.
- Designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
- Provide clinical/scientific input during the development, execution and completion of clinical trials Interpret clinical trial data and prepare reports, regulatory submissions and publications based on the results Monitor clinical trials for safety
- Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areas
- Devise strategy for, develop and implement clinical studies for investigational medicines and new indications for approved medicines
- Collaborate with the Preclinical Translational group to assure alignment of Translational Medicine strategy
- Collaborate with Project Management, Clinical Operations, Clinical Science, and Medical Writing departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts, and different scientific presentations.
- Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs and senior management
- Serve as medical representative with regulatory agencies
- Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
- Participate in clinical advisory board meetings to obtain strategic input into clinical program development
- Serve as clinical (and medical) resource for clinical issues raised by internal and external collaborators, investigators, consultants and business development and investor contacts
Experience / Professional Requirements:
- Demonstrated scientific and therapeutic expertise
- Experience in leading the design, conduct, analysis and reporting of clinical studies, including interactions with regulatory agencies
- Experience of interactions with regulatory agencies
- Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
- Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships
- Excellent organizational and time management skills, ability to lead and manage multiple complex projects
- MD degree with at least seven years’ experience in oncology clinical development, or related experience. Equivalent combination of education and experience.
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.