aTyr Pharma is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. aTyr is publicly traded on Nasdaq under the symbol “LIFE”. For more information, please visit http://www.atyrpharma.com.
Patients and their challenges provide tremendous drive and meaning to what we do at aTyr. We seek a talented and successful individual that deeply desires to participate in our process to make medicines that change a patient’s life forever.
The Associate Director, Clinical Operations will oversee global clinical trials
This key role will manage, plan, and execute clinical trials, including creating and managing study timelines, budgets, and study management plans. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development
deliverables and timelines are met. This position will report to the Head of Clinical Operations.
Manage and lead a team in clinical operations
Manage and execute clinical programs, including study management, budget and timeline creation
Lead across functional study teams, and understand the intricacies among the different groups
Participate in the development of protocols, IBs, CSRs and other clinical documents, ensuring they are completed within study timelines
Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed
Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
Ability to build strong KOL and Principal Investigator relationships
Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
May attend and/or participate in Qualification, Initiation and Monitoring site visits
Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
Author informed consent forms (ICFs), study management plans and other clinical documents as necessary.
Provide study specific training as needed
Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
Assist in authoring, reviewing and revising of SOPs
Assist in training of new staff and consultants
Attend clinical, scientific and industry conferences as needed
Bachelor’s degree required.
Minimum of 8+ years in clinical operations in the pharmaceutical/biotech industry (5+ years of study management)
Experience managing clinical trials, budgets, and timelines
Experience monitoring and/or overseeing clinical studies and conducting PSVs, SIVs, IMVs, and COVs
Experience managing CROs (or similar), multiple vendors, and complex protocols
Experience with protocol, ICF, and CSR development
Experience in global clinical trial management
Further Recruiting Information
For additional information about aTyr Pharma, please visit our website at www.atyrpharma.com. aTyr Pharma, Inc. is an EEO employer.
In addition to a competitive compensation package with stock options and an Employee Stock Purchase Plan, aTyr Pharma also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability and a 401(k) matching contribution.
For consideration, please submit your resume and cover letter referencing job #181LC to email@example.com. aTyr Pharma, Inc. is an EEO employer.