Angion Biomedica Corp. is a biopharmaceutical company discovering and developing novel therapeutic agents for acute and chronic organ diseases and disorders. Angion’s programs are currently focused on renal transplantation, acute kidney injury, and chronic kidney disease, with a pipeline of additional indications and product candidates in discovery and pre-clinical stages. Angion’s founder Itzhak D. Goldberg, M.D. FACR, now Executive Chairman and Chief Scientific Officer, conducted seminal research on tyrosine kinase receptors and hepatocyte growth factor. This work validated the HGF/c-Met pathway as a potential pharmacological target for intervention in multiple diseases affecting major organs.
Angion is a late stage pharmaceutical company, in Phase 2 and 3 for ANG-3777, a small molecule under development for the treatment of acute kidney injury of transplantation and cardiac surgery. In addition to other indications in acute organ injury, Angion has a rich pipeline of pre-clinical candidates, including an anti-fibrotic in Phase 1 testing.
Job Summary:
This position reports into the Director of Clinical Operations. The ideal candidate will possess an understanding of Clinical Operations for successful execution of multiple clinical trials. Work is primarily in Acute Kidney Disease and orphan indications in various phases of development.
Responsibilities:
Responsibilities of this position involve the day to day management and oversight of clinical trials in collaboration with a dynamic Clinical Development team.
Specific Responsibilities include:
• Independent management of the operational aspects of specific clinical trials, including the management of vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
• Identification and qualification of clinical trial sites and investigators alongside CRO including management of key relationships.
• Participation in site selection and the day to day supervision of clinical trial execution. Which includes, a focus on site start up, patient enrollment, monitoring, compliance, and data management.
• Management of clinical study budgets and execution timelines: from start-up through database lock, CSR completion and final deliver of the study TMF.
• Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials. Development and review of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
• Leads team meetings for study management. Including, facilitation of investigator meetings, kick-off meetings, training, and CRO (or other vendor) meetings.
• Attendance at site visits to ensure oversight of CRO monitors and effective collaboration with Investigators and site staff.
• Review study reports and metrics to ensure timely collection of clinical data, samples, and lab results.
• Collaboration on SOP development.
• Development of corrective action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
Qualifications:
• Education Required: Bachelor’s degree in a scientific discipline required. The advanced scientific degree is desired.
• The candidate should ideally have 5 + years in trial management with a sponsor company managing various phase clinical trials.
• Experience in various phases of clinical trials and various therapeutic areas would be helpful.
• Experience in CRO, vendor and laboratory oversight is required.
• Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• Creative problem solver with excellent communication and public speaking skills.
• Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.
• Ability to travel both domestic and international, may be needed. Required Travel: 20-30%
• Detailed knowledge of GCP and current US FDA regulations, and knowledge of other relevant global regulatory requirements a plus.