About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.
Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates into the clinic with an anticipated first IND filing mid-2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept.
The Morphic Therapeutic office is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.
Morphic Therapeutic is seeking an experienced and motivated Toxicology Study Manager to join our rapidly growing organization. Reporting to the Associate Director, Toxicology, this critical position will help support the contracting and conduct of non-clinical toxicology and bioanalytical studies with Contract Research Organizations (CROs). The Study Manager is key to the success of various stages of drug development. The Manager will be primarily responsible for coordinating contractual agreements, managing the operational aspects of preclinical studies, and test article shipment tracking. The Manager will also work closely with preclinical representatives and program teams within the Development group and will collaborate with cross-functional project team members. We are looking for someone that has proven ability to effectively manage multiple projects and timelines simultaneously.
Scope of Work and Responsibilities:
- Manage outsourcing of pre-clinical studies (GLP and non-GLP) for inclusion in regulatory submissions under aggressive timelines.
- Oversee operational aspects of preclinical studies to ensure timely delivery of key data to inform project decisions.
- Work within established CRO agreement terms to support preclinical development programs. Collaborate with internal toxicology, bioanalytical and other team members.
- Participate in CRO qualification/scientific assessments and tracking vendor performance.
- Oversee CRO partners to ensure consistent practices across vendors, groups and sites, communicate and trouble-shoot issues and track/forecast activities and spending.
- Helps manage the Master Schedule for both internal and external preclinical studies.
- Track the preparation and review and manage the circulation of study documents.
- Maintain complete, organized, and current study files including study schedules, contracts, protocols, and other applicable documents.
- Manage report and sub-report timelines and ensure all study reports are appropriately organized and archived.
Location/Region: Waltham, MA (02451)