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 inflammatory, hepatic, fibrosis, cardio-pulmonary, 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.
The Clinical Trial Manager will be responsible for the implementation and conduct of clinical trials. These activities include site feasibility analysis and selection, vendor evaluation, day-to-day oversight of study conduct, contract research organizations (CROs) and vendors, management of the relationships with clinical sites, and study start-up and closeout activities. She/he will be accountable for the completion of the clinical activities on time and within budget. She/he will ensure timely collection and validation of all the study-related data and documentation. The successful candidate will work collaboratively with the members of the research and development organization in the Company and will report to the Head of Clinical Operations.
- Responsible for the clinical operation activities from the trial start-up to closeout, including helping to provide appropriate oversight to any CRO executing Morphic’s clinical trials.
• Participates in the development of trial documentation, including the protocol, informed consent forms, monitoring plan, and study manuals.
• Facilitates site feasibility and selection process.
• Serves as the point person managing clinical protocol execution.
• Establishes study milestones and ensures accurate tracking and reporting of study metrics and timelines.
• Responsible for trial adherence to ICH/GCP/Federal and local regulations and Company-specific SOPs.
• Reviews and ensures completeness of the Trial Master File (TMF).
• Facilitates and responds to Quality Assurance and regulatory authorities inspection audits.
• Proactively identifies and communicates the study-related problems and proposes solutions
• Develops and maintains strong, collaborative relationships with vendors, CROs, clinical site personnel.
• Collaborates effectively with the members of the cross-function project teams
Location/Region: Waltham, MA (02451)