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Sr. Director Toxicology/DMPK

2 months ago

Bedford, United States Delix Therapeutics Full time

Delix Therapeutics is a neuroscience company focused on harnessing the power of neuroplastogens—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 team in a growing R&D organization. Reporting to the Chief Medical Officer, the Sr. Director of Toxicology/DMPK 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, and interacting with regulatory agencies.

Working with Research, Bioanalytical, and Clinical Pharmacology subject matter experts, the candidate will provide scientific leadership to ensure that clinical drug candidates with acceptable drug development characteristics are identified and appropriately characterized. The candidate will also represent preclinical development on Research and Development teams and regularly interface with internal and external colleagues to ensure timely and accurate dissemination of findings.

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.
  • Design, execute and manage, interpret, and report PK, PK-PD, and PK-PD drug metabolism studies.
  • Review study protocols, attend meetings with CROs regularly to ensure integrity and quality of studies, 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 other functions including clinical pharmacology, regulatory affairs, clinical development, CMC, etc.

Qualifications

PhD in toxicology or related field

Experience placing and monitoring studies externally is required

Proficiency in DMPK is required

Board Certification in Toxicology is desired

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

Ability to serve as company expert/liaison for in-licensing/out-licensing activities

Strong organizational skills and ability to manage multiple assignments

Excellent written and verbal communication skills

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