Director, Clinical Science

Janux Therapeutics; San Diego (CA); Hybrid; USD 236,000 - 255,000; Full time

Benefits offered by this job

Annual bonus program

Stock options

401k plan

Medical insurance

Dental and vision insurance

HSA/FSA and supplemental plans

Unlimited PTO

Holiday schedule with company shutdown

Relocation assistance

Job summary

Janux Therapeutics, a clinical-stage immuno-oncology company, seeks a Director of Clinical Science to shape development strategies for one of its early-stage oncology platforms. You will partner with Clinical Operations to design trials, develop essential documents, and monitor data for informed decisions.

You will have 8+ years in biotech/pharma, with 5+ years running clinical trials, and a strong foundation in GCP and regulatory knowledge.

Qualifications

• BS in life sciences or related field; advanced degree preferred.
• Minimum 8 years of industry experience, 5+ years in conduct of clinical trials as a Clinical Scientist.
• Knowledge of oncology drug development, trial processes, design, statistics, and regulatory requirements.
• Ability to lead cross-functional teams and evaluate data critically.

Responsibilities

• Support development strategies for programs entering the clinic with clinical science input.
• Collaborate with Clinical Operations for design and execution of trials and creation of Protocols, ICFs, CRFs, CSR, and Investigator Brochures.
• Help develop Data Review Plan and Strategy ensuring consistency across the study.
• Perform clinical data review and identify insights through patient-level review and trends analysis.
• Promote data quality and safety review, data integrity, trend identification, and AE/SAE assessment.
• Assist in regulatory activities by authoring/reviewing regulatory documents and participating in meetings with agencies.
• Develop and deliver clinical presentation slides and materials for internal and external meetings.
• Maintain scientific knowledge in therapeutic areas and stay updated on disease states.

Skills

Leadership

Cross-functional

Project management

Data review

GCP knowledge

Regulatory knowledge

Data interpretation

Clinical trial design

Education

Bachelor's in life sciences

MS/PhD in life sciences preferred

Job description

An integral member of the Janux Therapeutics’ Clinical Development team; the Director, Clinical Science will support the strategic planning and execution of clinical-stage programs for one of the the company’s early stage oncology platforms. 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.

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

$236,000 - $255,000 a year

In addition to a competitive base salary ranging from $236,000 to $255,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.

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

• Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required.

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.