Nonclinical Operations Manager
Nonclinical Operation Manager/Senior Manager
Protagonist Therapeutics is seeking a talented and highly motivated professional to join the Nonclinical Development group as the Nonclinical Study Operational Manager/Senior Manager. This position will oversee and coordinate the operational, organizational, logistic, regulatory, and compliance aspects of outsourced nonclinical toxicology and related studies to support our proprietary peptide-based drug development from preclinical, clinical through registration and post-market. This position will report to the Senior Director of Nonclinical Development.
A self-starter with excellent nonclinical toxicology study management and coordination capabilities and a critical part of an innovative team to support the company’s drug development pipelines.
Coordinate with CRO Study Directors and Managers, Chemistry, Biology, DMPK/TK, Formulation, Quality, CMC, and/or Bioanalytical colleagues and vendors during the entire process of the studies.
Request quotes and recommend the most appropriate one from different CROs based on quality, cost-effectiveness and timeline.
Coordinate the drafting and review of study protocols and amendments, coordinating the shipment of test articles, samples and biological specimens.
Track the timeline and milestones of the studies (protocol development, inlife conduct, receipt of datasets, post-inlife reporting, finalization, etc).
Monitor nonclinical study progress and documents involved in various aspects of the projects, coordinate CROs and internal resources to ensure the projects are on schedule and the results are delivered to meet team-imposed timeline.
Prepare nonclinical budgets, track the approval of service agreements, change of orders, accruals per study completion status and approved budgets, ensuring timely invoice and payments.
Assist the manager in performing data analysis, visualization (graphing and tabulation) and presentation to nonclinical and company managements. Monitor and review deliverables for completeness, regulatory compliance, and scientific integrity. Assist the manager in preparing and/or QC documents for major and routine/minor regulatory submissions to US and ex-US regulatory agencies. These documents may include CTD summary and tabulated modules, IB, annual reports, and/or study reports.
Manage and archive critical documents, samples, and specimens in collaboration with functional team members to store and track study related documents. Manage master study schedule for all nonclinical studies across all the R&D programs at various stages of development.
A bachelors or master’s degree in biological sciences or related discipline and 5-8 years of related experience in the pharmaceutical or biotechnology industry environment.
Experience in outsourcing, vendor management, and establishing and managing CROs for timely delivery of clear, accurate, and well-written nonclinical study data and documents.
Proficient knowledge in GLP regulation, and current knowledge of the ICH and regulatory nonclinical guidelines. Current training on nonclinical and related SOPs and being familiar with IACUC regulation.
Strong verbal communication skills accompanied by scientific and/or medical writing skills.
Enjoy and thrive in a fast-paced, matrix, multi-tasked, and hands-on working environment.
About Protagonist Therapeutics, Inc.
Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based drugs to transform existing treatment paradigms for patients with significant unmet medical needs. Protagonist is developing an injectable hepcidin mimetic, PTG-300, for the potential treatment of anemia and iron overload related to rare blood diseases with an initial focus on beta-thalassemia. The Company has completed a Phase 1 clinical trial with PTG-300, which established pharmacodynamic-based clinical proof-of-concept in normal healthy volunteers. A phase 2 study in beta-thalassemia is ongoing. The U.S. Food and Drug Administration has granted Orphan Drug and Fast Track Designation to PTG-300 for beta-thalassemia. PN-943 is an oral alpha-4-beta-7 integrin antagonist peptide that is under evaluation for potential treatment of inflammatory bowel diseases. The Company's interleukin-23 receptor antagonist peptide, PTG-200, has completed a Phase 1 clinical trial in healthy volunteers and is in development for treatment of Crohn's disease. The IL-12/23 pathway blockade is an approach that has been validated through an FDA-approved injectable antibody drug. The company has entered into a worldwide license and collaboration agreement with Janssen Biotech for the clinical development of PTG-200.
Protagonist is headquartered in Newark, California, with pre-clinical and clinical staff in California and discovery operations in both California and Brisbane, Queensland, Australia. For further information, please visit http://www.protagonist-inc.com.
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