Delix Therapeutics is a neuroscience company focused on harnessing the power of psychoplastogens-novel neuroplasticity-promoting therapeutics-to treat brain health disorders. Delix is advancing these compounds through preclinical and clinical development to bring patients FDA-approved medicines that will address significant unmet needs. Headquartered in Massachusetts, Delix is building a world-class biotechnology company by combining an experienced team with innovative treatment strategies and scientific rigor to address the significant and growing brain health challenges impacting society.
The Position
Delix Therapeutics is seeking an experienced toxicologist to lead our toxicology area for our growing R&D organization.
Reporting to the Chief Scientific Officer, the Sr. Director of Toxicology will be the primary person responsible for designing and overseeing nonclinical safety assessment programs for CNS drug candidates. This includes strategic oversight for all aspects of toxicology for the programs including, developing study protocols and reports, and interpreting data from various studies. The candidate will also be responsible for writing nonclinical sections of regulatory documents (e.g., pre-IND packages, INDs/CTAs, BLAs/NDAs, Investigator Brochures), risk assessment documents, etc. and interactions with regulatory agencies.
Responsibilities:
The position will require an in-person hybrid presence in Bedford, MA. In addition to above, duties may include:
Design toxicology and safety pharmacology studies to support research and development programs
Serve as a study monitor: review study protocols, attend meetings with CROs regularly to ensure integrity and quality of the study, critically review study reports and interpret the data.
Prepare nonclinical sections of regulatory documents (e.g., pre-IND packages, INDs/CTAs, BLAs/NDAs, Investigator Brochures) and interactions with regulatory authorities as needed
Collaborate with functional areas including clinical pharmacology, regulatory affairs, clinical development, CMC, etc.
Qualifications:
PhD in toxicology or related field
Experience placing and monitoring studies externally is required
Experience with DMPK is required
Board Certification in Toxicology is desirable
More than 8 years' relevant experience in industry conducting pharmaceutical research and development in small molecules; experience in CNS drug development is required.
Familiar with ICH, EU, and FDA regulatory guidance documents for nonclinical drug development
IND experience is required, NDA experience desired.
to serve as company expert/liaison for in-licensing/out-licensing activities
organizational skills and ability to manage multiple assignments
written and verbal communication skills
Delix is an equal opportunity employer committed to a diverse and inclusive work environment.
Recruitment and Staffing Agencies: Delix Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Delix or its employees is prohibited unless contacted directly by Delix Talent Acquisition Team