Director, Preclinical Development
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 a Phase 1/2 study of FX-322, the company observed clinically meaningful improvement in key measures of hearing function in patients with sensorineural hearing loss, the most common form of hearing loss. A Phase 2a study is anticipated to begin in Q4 2019. The Frequency 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 discovery program in multiple sclerosis.
Reporting to the Chief Development Officer, the Director, Preclinical Development 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 preclinical development (PCD) 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 PCD studies and implement strategies to enable selection of drug candidates for development.
- Conduct/oversee IND-enabling toxicology studies to support regulatory filings.
- Align PCD activities and plans with Clinical Development strategy.
- Interface with Biology, Pharmaceutical Development, and Drug Delivery departments on relevant projects.
- Integrate and maximize the contribution of science and technologies to the development process.
- Implement established and newly developed technologies in current and future generation products.
- 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 PCD for FREQ at partnership meetings, as well as health authority meetings.
Skills and Qualifications:
- PhD (or equivalent degree) in scientific field (chemistry, neuroscience, or pharmacology)
- 6-10 years of biotech or biopharma experience with a unique drug delivery experience is preferred
- Previous IND experience and an understanding of international PCD 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.
A fundamental belief held by the Frequency Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large.
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Director, Preclinical Development