Associate Director/Director, Toxicology
Frequency Therapeutics (Nasdaq: FREQ) is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The company’s lead product candidate, FX-322, is a potential disease modifying therapy designed to regenerate damaged auditory hair cells to improve hearing function. In initial clinical studies of FX-322, the company observed meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss, the most common form of hearing loss which impacts more than 90 percent of all people with hearing loss. The company recently completed enrollment of a Phase 2a study, with results to be shared in Q2 2021. Frequency’s progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue and the Company is researching an array of additional degenerative diseases where PCA may be applied, including a pre-clinical program for remyelination in multiple sclerosis.
Reporting to the Chief Development Officer, the Associate Director/Director, Toxicology will lead the company’s toxicology, pharmacokinetics and ADME assessments on all drug candidates in order to support the advancement of all clinical development programs.
- Oversee toxicology-related activities for all FREQ drug candidates.
- Design, plan and execute experiments to establish safety profile of candidate molecules
- Conduct/oversee toxicology, PK/TK and ADME studies and identify biomarkers of toxicity
- Monitor CRO based toxicology and related studies and implement strategies to enable selection of drug candidates for development
- Conduct/oversee IND-enabling toxicology studies to support regulatory filings
- Align toxicology-related activities and plans with Clinical Development strategy
- Interface with Program Management, Regulatory Affairs, Clinical Development, Biology, Pharmaceutical Development, and Drug Delivery departments on relevant projects
- Integrate and maximize the contribution of science and technologies to the development process
- Provide scientific/technical guidance, leadership and decision-making as appropriate.
- Lead writing and review of relevant regulatory documents including IND, NDA and international health authority filings
- Represent toxicology for FREQ at partnership meetings, as well as health authority meetings
Skills and Qualifications:
- PhD (or equivalent degree) in scientific field (toxicology, chemistry, neuroscience, or pharmacology)
- 5-8 years of biotech or biopharma experience
- Previous IND/NDA experience and an understanding of international toxicology requirements is essential
- Solid PK/TK background with ADME experience
- Exceptional organizational skills and attention to detail, with demonstrated leadership among peers and teammates to meet critical deadlines
- A proactive communicator with professional written and verbal communications skills and the ability to operate successfully both independently and within a dynamic, multi-disciplinary environment
- Ability to travel up to 10%
Working at Frequency
At Frequency Therapeutics, we believe that we have the best chance to achieve our mission by creating an environment where our collective problem-solving and leadership skills are put to work, so collaboratively, we can solve some of the most complex challenges in medicine. We are focused on developing new treatments to potentially help millions of patients with novel therapeutics. This requires both a willingness to be audacious in our pursuits and relentless in our focus and commitment to research and patients. We look for individuals who are both highly skilled and self-aware, who are willing to challenge leadership and their colleagues, are entrepreneurial by nature and who are undeterred by uncertainty.
Please visit www.frequencytx.comfor more information.
We offer a competitive compensation and benefit package. For consideration, please submit CV and cover letter.