Director, Clinical Science (Autoimmune)

An integral member of the Janux Therapeutics’ Clinical Development team; the Director, Clinical Science will be a key contributor to Janux Therapeutics’ Clinical Development team, supporting the strategic planning and execution of clinical-stage programs for the company’s newly announced ARM (Adaptive Immune Response Modulator) platform. This role partners closely with Clinical Operations to ensure effective trial conduct and supports the Clinical Lead in delivering critical trial milestones.

This role is perfect for individuals passionate about science-driven strategy and want to be at the forefront of immunotherapy innovation, as their opportunity to make a difference.

• 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

• Advanced degree 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 Autoimmune 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:

·         401K

·         Medical insurance

·         Dental insurance

·         Vision insurance

·         Supplemental disability insurance plans

·         Flexible schedule

·         Life insurance

·         Flexible vacation

·         Sick time

·         Incentive stock option plan

·         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.