- DVM/PhD or 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
- Experience with regulatory submissions and responses
- This position will be part of the Preclinical and Clinical Development Sciences (PCDS) team supporting development as a primary representative of PCDS on Program Teams.
- Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences
- Provide risk assessment and de-risking strategies for discovery programs
- Design preclinical strategies for Discovery and Development candidate molecules
- Design toxicity studies: coordinate with Preclinical Outsourcing for placement and monitoring of the studies as well as the Bioanalytical and DMPK groups regarding integration of bioanalysis and toxicokinetic aspects into these studies to ensure on-time delivery of key data and study reports
- Work with Platform Discovery Sciences, Translational Medicine and 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 teams
- 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
- Provide leadership as a key member of the Preclinical Development Leadership Team with opportunities for continual organizational advancement
- 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 oversee CRO interface, as appropriate, to deliver high quality, cost-effective, and timely safety assessment
- Ability to collaborate with colleagues, internally and externally, to execute on the appropriate studies to support selection of therapeutic targets, and the identification and development of new drug candidates
- Ability to travel to monitor out-sourced studies
- Outstanding organizational skills/ability to prioritize and deliver in timely fashion
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Associate Director, Translational Toxicology, Preclinical Development - Lexington, United States - Wave Life Sciences
Description
Job DescriptionWave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington's disease, as well as a preclinical program in obesity. Driven by the calling to "Reimagine Possible", we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
Description:
Wave Life Sciences is seeking a highly motivated individual to join the Preclinical and Clinical Development Sciences team in Lexington, Massachusetts. The candidate will be expected to provide scientific expertise and leadership across the Discovery and Development portfolio by contributing to the safety assessment of novel therapeutic oligonucleotides intended for the treatment of rare 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 the safety assessment of drugs intended to treat diseases of the hepatic, kidney, muscular and central nervous systems.
Experience:
Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences.
