Preclinical Safety Assessment (PSA) is a global function responsible for the design and conduct of nonclinical safety programs for the comprehensive safety assessment of Vertex therapies at all stages of discovery and development. Vertex Pharmaceuticals uses cutting edge science and technologies to perform robust assessments of novel therapies for the treatment of the most serious diseases with unmet medical need. Our culture enables individual empowerment where \"We Wins\" \"Fearless Pursuit of Excellence\" and \"Innovation\" are more than just corporate values, they are part of our everyday lives.
PSA members have significant roles in the drug development process beginning in the early drug discovery phase and continuing through the entire drug development value chain resulting in successful registration and marketing approval. We are actively recruiting for a Regulatory Toxicology Lead. You will report directly to the Head of Regulatory Safety Assessment and will be responsible for the design and conduct of nonclinical safety assessment programs to support progression of novel therapeutic agents through the drug development process. A strong background in regulatory toxicology including extensive knowledge and understanding of Good Laboratory Practices is required. Considerable experience in the safety assessment of genetic therapeutics is a plus.
Summary of Responsibilities:
* Design and oversee the conduct, interpretation, and reporting of regulatory toxicity studies
* Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with discovery toxicologists, and affiliated nonclinical and clinical development functions as necessary
* Coordinate toxicological/nonclinical safety evaluations of development candidates locally and internationally with external contract laboratories, consultants, and development partners
* Responsible for lead authorship of pertinent sections of internal and external regulatory documents (IBs, CTXs, INDs, NDAs, Expert Reports, etc.)
* Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of any toxicological findings to human safety.
* Communicate unambiguous critical and significant project information to various bodies including project teams and Vertex leadership as required
* Build strong scientific collaborations with external groups within both the academic and industrial sectors with the intent of enhancing Vertex's PSA capabilities.
* Collaborate on design of investigative toxicity studies in support of development compounds as needed
* Ph.D. in Toxicology or relevant field; DABT Board certification preferred.
* 10 plus years of experience in the Pharmaceutical Industry with a proven track record of conduct of drug safety assessment studies, demonstrated ability to manage multiple scientific projects and make sound scientific interpretations and risk assessments
* Proficient knowledge of general toxicology is required
* Expertise in a toxicology specialty area a plus (especially the safety assessment of genetic therapeutics or specialty biologics)
* In depth understanding and working knowledge of regulatory toxicology and US and international regulatory guidelines
* Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities
* Strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting/matrix-type organization
* Excellent oral and written communication capabilities, essential for successful contributions to Global PSA
Associated topics: chemical engineer, design, designer, drawing, engineering, plc, process engineer, software, software implementation, ultrasonic
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.