What are the responsibilities and job description for the Associate Director / Director, Preclinical Development position at Q-State Biosciences, Inc.?
Q-State Biosciences is seeking a highly motivated individual to join the Research and Development team in Cambridge, Massachusetts. The candidate will be expected to provide scientific expertise and leadership across the portfolio of therapeutic programs by contributing to the safety assessment of novel therapeutic oligonucleotides intended for the treatment of neurological diseases. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is required as is a background in neurochemistry, neuroanatomy and the safety assessment of drugs intended to treat diseases of the nervous system.
Responsibilities and Duties:
- Design preclinical strategies for candidate molecules
- Design toxicity studies and identify appropriate external vendors for execution of studies
- Coordinate placement and monitoring of the studies as well as the integration of bioanalysis and toxicokinetic aspects into these studies to ensure on-time delivery of key data and study reports
- Work with program teams to utilize and interpret animal models of diseases for efficacy/tolerability assessment and PK/PD evaluation
- Lead the development of early hypothesis-driven investigation into mechanisms of toxicity for the proactive management of potential safety liabilities and communication of impact to team
- Provide strategic guidance to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy
- Lead issue-resolution teams, driving the science for investigative and discovery toxicology as needed
Qualifications Required:
- PhD in biology, toxicology or related field,
- Board certification in toxicology is highly desirable
- Relevant experience (7 -years) in preclinical safety assessment of novel therapeutic entities
- Knowledge of GLP compliance and relevant ICH & FDA guidance documents
- Outstanding interpersonal skills and verbal and written communication skills
- Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment
- Ability to work well with external CROs and collaborators with professionalism and discretion
- Ability to travel to monitor out-sourced studies
- Outstanding organizational skills/ability to prioritize and deliver in timely fashion.