Director, Clinical Science
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
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 team members to support the design and execution of clinical trials. This may include assistance in the development of essential clinical trial documents such as protocols, ICF documents/amendments, CRF’s, CSR’s, and Investigator Brochures
Aid in the development of the Data Review Plan and Data Review Strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study
Perform clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, working cross-functionally to monitor clinical data
Promote quality review of data with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of AEs/SAEs for medical review
Support ad-hoc Regulatory activities such as contributing by authoring/reviewing clinical portions of Regulatory Documents and/or posters, abstracts and manuscripts, and the preparation and conduct of meetings with regulatory agencies and/or external drug development consortiums
Develop and deliver upon clinical presentation slides and other materials for internal and external meetings
Maintain scientific and clinical knowledge in the specific therapeutic and disease areas of assignment
Other duties as required
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES
- BS in life sciences or related field; advanced degree (MS or PhD) in life sciences preferred
- 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, study design, statistics and 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, dose review teams, and independent response adjudication committees
- Knowledge of GCP and regulatory requirements
- Ability to critically evaluate data, literature and presentations
- Ability to lead and work with cross-functional teams
- Strong project management skills
Job Type: Full-time
Benefits:
- Annual bonus program
- Incentive stock option plan
- 401k plan with flat non-elective employer contribution
- Comprehensive medical insurance with 90-100% employer-paid premiums
- Dental and vision insurance
- HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
- Unlimited PTO
- Generous holiday schedule; includes summer and winter company shutdown
- Relocation assistance
Schedule:
- Monday to Friday
Work authorization:
- United States (Required)
Additional Compensation:
- Annual targeted bonus %
Work Location:
- On site (San Diego, CA)
EQUAL OPPORTUNITY EMPLOYER:
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Notice to Recruiters and Third-Party Agencies
The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.