Director, Clinical Science
On-siteSan Diego, California, United States
Job Summary
Support the design and implementation of development strategies for programs entering the clinic, providing strategic clinical science input for all assigned programs. Collaborate cross-functionally with Clinical Operations to support the design and execution of clinical trials, including assistance in developing protocols, ICF documents, CRFs, CSRs, and Investigator Brochures. Aid in the development of the Data Review Plan and Data Review Strategy, ensuring protocol-level deviations and eligibility criteria are implemented consistently. Perform clinical data review and identify insights through ongoing patient-level review and trend analysis, while promoting quality review with an emphasis on subject safety, data integrity, and AE/SAE identification. Author and review clinical portions of regulatory documents, posters, abstracts, and manuscripts, and conduct meetings with regulatory agencies and external drug development consortiums. Develop and deliver clinical presentation materials for internal and external meetings. Maintain scientific and clinical knowledge in specific therapeutic and disease areas of assignment. Janux Therapeutics is an equal opportunity employer committed to a harassment-free work environment.
Required Qualifications
- BS in life sciences or related field
- Minimum 8 years of industry experience
- 5+ years of which dedicated to the conduct of clinical trials as a Clinical Scientist
- Knowledge of oncology drug development and clinical trial processes
- Knowledge of study design
- Knowledge of statistics
- Knowledge of clinical operations within a similar biotech and/or pharmaceutical environment
- Skills to support program-specific data review and trend analysis
- Knowledge of the establishment and operation of data monitoring committees
- Knowledge of dose review teams
- Knowledge of independent response adjudication committees
- Knowledge of GCP
- Knowledge of regulatory requirements
- Ability to critically evaluate data
- Ability to critically evaluate literature
- Ability to critically evaluate presentations
- Ability to lead and work with cross-functional teams
- Strong project management skills
Desired Qualifications
- advanced degree (MS or PhD) in life sciences
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