Reporting into the Chief Scientific Officer, the Director/Senior Director of Toxicology will be responsible for the management of the non-clinical toxicology function within Janux Therapeutics. The incumbent will focus on the design, execution and oversight of non-clinical safety studies to drive forward IND-enabling studies into the clinic. The ideal candidate will be a key contributor to the therapeutic development process, representing the toxicology function in meetings with executive management and regulatory authorities to include presentations of strategy, results, and progress-versus-goals. In addition, he/she will author regulatory submissions, negotiate technical aspects of contracts, and manage the toxicology-specific outsourcing plans and budgets.
- Develop, execute and direct the toxicology strategy for each drug candidate throughout the stages of development; from preclinical to late-stage clinical trials.
- Design, execute and direct all non-clinical studies, including exploratory and GLP studies, being conducted internally or through CROs.
- Critically evaluate and interpret results of all safety pharmacology and toxicology studies to internal project teams and executive management.
- Serve as the internal Subject Matter Expert for non-clinical safety pharmacology and toxicology for internal and external stakeholders.
- Author, review and/or edit safety pharmacology and toxicology sections of regulatory documents to include INDs, CTAs, FDA Briefing Documents, Investigator Brochures, etc.
- Participate in interactions and/or represent Janux Therapeutics with global regulatory authorities.
- Develop optimal CRO network for toxicology studies, build and maintain effective vendor relationships.
- Other duties as necessary.
- A Master’s Degree in Toxicology or a relevant field with 12+ years of experience as a toxicologist within the biotech/pharmaceutical industry is required. A PhD graduate with 8+ years of industry experience is highly preferred and will be given priority.
- Board certification in Toxicology is highly desired.
- Previous large molecule development experience and/or oncology product development experience within a biotech/pharmaceutical organization is preferred.
- Strong familiarity with GLP regulations and regulatory guidelines for the testing of products and experience with compilation of toxicology data into regulatory submission documents is required.
- Previous experience leading IND-enabling studies, and the creation of documents to support successful regulatory submissions is required.
- Excellent written and verbal communication skills, ability to multi-task and shift priorities, and the ability to work well with cross functional teams is essential.
- Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies.
In addition to a competitive compensation package with stock options and stock purchase plan, Janux also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance is also available.
Job Type: Full-time
- Medical insurance
- Dental insurance
- Vision insurance
- Supplemental disability insurance plans
- Flexible schedule
- Life insurance
- Flexible vacation
- Sick time
- Incentive stock option plan
- Relocation assistance
- Monday to Friday
- United States (Required)
- Annual targeted bonus %
- On site – La Jolla/Torrey Pines
COVID-19 Vaccination required
Janux requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Janux will consider requests for Reasonable Accommodations.
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