Associate Director, Translational Toxicology, Preclinical Development - Lexington, United States - Wave Life Sciences
Description
Job Description
Wave 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:
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
Responsibilities:
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.
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
Key Skills:
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
Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.
In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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.
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