Preclinical Study Coordinator II Position Available In Middlesex, Massachusetts

Preclinical Study Coordinator II Wave Life Sciences – 4.3

Lexington, MA Job Details Full-time Estimated:

$64.3K – $79.9K a year 1 day ago Qualifications Biology GLP Bachelor of Science Laboratory experience Mid-level Microsoft Office Master’s degree Project management Bachelor’s degree Master of Science Toxicology 2 years Communication skills Editing Full 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:

This individual supports multiple preclinical programs and is responsible for sourcing and managing non- GLP and GLP preclinical toxicology and pharmacokinetic studies by proactively maintaining effective cross-functional communication and study monitoring to ensure timely delivery of high-quality study reports from various external vendors. This individual acts as the liaison between Wave Internal functional Groups and Contract Research Organizations (CRO) to confirm and track deliverables of collected samples, documentation, data, and reports to ensure internal and external alignment and proper coordination of preclinical studies. This is a hybrid position located in our Lexington, MA office.

Experience:

B.S. / M.S. or equivalent in biology, biochemistry, toxicology or a related field 2-5 years of experience in a biopharmaceutical company Experience as a Study Monitor/Project Manager in a preclinical toxicology group is essential Demonstrated understanding of GLP and regulatory requirements for the conduct on toxicology studies

Responsibilities:

Collaborate closely with Wave toxicologists, study sub-teams (internal/external) and Contract Research Organization (CRO) partners Align with program toxicologists on the design and timing of studies needed to support key clinical milestones Collaborate with program toxicologists to manage and chair cross-functional pre-clinical sub-teams for assigned programs to enable efficient communication between pre-clinical sub-teams and program teams Work closely with relevant Wave colleagues and CROs to coordinate and track all study-related documentation, specimen shipment, reporting timelines and archiving by maintaining appropriate file management and document control for assigned programs including timely delivery of final reports and SEND datasets Travel to contract labs to monitor procedures on active studies as needed (as coordinated with program toxicologists) Write detailed CRO monitoring reports and maintain study tracking tools and study calendar Support implementation and management of nonclinical toxicology projects through file management and document control Support financial aspect of preclinical development studies via contract processing, purchase order generation, processing of timely/accurate invoice payments and support for budget forecasting Obtain cost estimates and Statements of Work for individual studies or programs from CROs and schedule studies to meet program timelines Participate in new CRO qualification and re-qualification of established partners as requested to ensure the highest quality studies are compliant with all regulatory standards Participate in discussions and resolution meetings with CROS as they arise Stay current on CRO industry news and changes to business models

Key Skills:

Excellent communication and interpersonal skills Superior understanding of Microsoft Office products Aptitude for organizational detail, change agility, and ability to manage multiple projects concurrently Capacity to complete tasks independently in a highly regulated environment Flexibility to function well within a team environment and within condensed timelines Ability to verbalize complex study issues and demonstrated problem-solving ability Documented knowledge of regulatory requirements and good laboratory practices (GLP) 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. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.