A bit about us:

We are a clinical-stage biopharmaceutical company that is translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. We apply insights into the genetic mutations that drive excitation-inhibition imbalance in diseases to select biological targets for severe pediatric epilepsies and more broadly for prevalent psychiatric diseases and neurologic disorders.

We share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.

Why join us?

Full suite of benefits
100% remote position

Job Details

Essential Functions
Design and oversee the conduct, interpretation, and reporting of regulatory toxicity studies
Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with affiliated nonclinical and clinical development functions as necessary
Coordinate toxicological/nonclinical safety evaluations of development candidates locally and internationally with external contract laboratories, consultants, and development partners
Responsible for lead authorship of pertinent sections of internal and external regulatory documents (IBs, CTXs, INDs, NDAs, Expert Reports, etc.)
Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of any toxicological findings to human safety.
Communicate unambiguous critical and significant project information to various bodies including project teams and Praxis leadership as required
Build strong scientific collaborations with internal and external groups within the academic and industrial sectors
Collaborate on design of investigative toxicity studies in support of development compounds as needed.


Education, Behavioral Competencies and Skills

  • Ph.D. in Toxicology or relevant field; DABT Board certification preferred.
At least 5 years of experience in the Biotech/Pharmaceutical Industry with a proven track record of conduct of drug safety assessment studies, demonstrated ability to manage multiple scientific projects and make sound scientific interpretations and risk assessments
Proficient knowledge of general toxicology and experience as a project toxicologist
Experience authoring of health authority documents (INDs, IBs, CTXs, NDAs) is required
Expertise in a toxicology of antisense oligonucleotides is a plus
In depth understanding and working knowledge of regulatory toxicology and US and international regulatory guidelines
Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities
Strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting/matrix-type organization
Excellent oral and written communication capabilities