Associate Director Clinical Operations
Overview of Company:
Equillium (www.equilliumbio.com) is a clinical stage biotech company (NASDAQ:EQ) focused on developing novel therapies for severe and life threatening autoimmune and inflammatory diseases. Equillium’s initial product candidate, itolizumab, is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is a clinically-validated therapeutic that has demonstrated a favorable safety and tolerability profile. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Biocon has recently reported results from a study of itolizumab in COVID-19 patients in India, and has subsequently received emergency use authorization from the Drugs Controller General in India for itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS). Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic and is developing itolizumab in multiple severe immuno-inflammatory disorders – acute graft-versus-host disease, uncontrolled asthma, and lupus nephritis – and is planning to submit an IND for the treatment of COVID-19 patients.
Overview of Position:
The (Associate) Director, Clinical Operations is a key position responsible for the global execution of clinical studies and programs. The position will report to the Sr. Director, Clinical Operations. The (Associate) Director, Clinical Operations must have a mastery of FDA regulations, GCP and ICH guidelines relating to industry sponsored clinical research. The (Associate) Director will lead a cross functional internal team and engage and manage vendors/partners. Establish working practices that promote and maintain a culture of quality, compliance and inspection readiness at all times. Lead operations activities of project(s) and/or program(s).and provide oversight.
Essential Duties & Responsibilities:
Establish goals in implementation of current company program objectives based upon principles of good clinical practice (GCP) in clinical operations and project management.
Accountable to ensure study teams are fully resourced with appropriately skilled staff and that clinical programs are implemented and risks are managed within scope, on time and within budget.
Accountable for the delivery of assigned clinical program milestones.
Management of third party relationships engaged in the clinical programs.
Work with functions outside the clinical group to ensure task completion, promote understanding and awareness of clinical programs
Actively manage and complete tasks, documents, plans, etc (draft and review) to ensure successful completion of assigned projects with main focus being clinical operations and clinical project management components, but also includes functional input to documents/decisions, etc lead by other team functions.
Develop and may manage clinical operations staff to meet current and future business needs.
Lead clinical operations activities in the preparation and coordination of clinical trial set-up, maintenance and closure in accordance with GCP and SOPs.
Provide study management by interfacing with representatives from key functional groups such as: Clinical Development, Data Management, Biostatistics, Regulatory Affairs, QA, Medical Writing, CMC, and Research
Actively support other functional groups with clinical trial set-up, maintenance and closure (e.g. data management, biostatistics, medical writing, clinical trial material vendors, etc.)
Provide expertise and direction on the activities involved with planning, conducting and reporting of clinical data.
Lead trial initiation activities including protocol development, activities for investigator site selection and regulatory preparedness, investigator budget and contract negotiation, and clinical vendor procurement activities.
Actively engage in study oversight to monitor adherence to GCP with timely and appropriate escalation of issues as necessary.
Participate in the development and review of regulatory documents as appropriate.
Conduct site clinical site monitoring activities as needed.
Other duties as assigned.
Meet with and gather information on new vendors to build a knowledge base and maintain understanding of available services.
Complete vendor proposal requests in conjunction with the contracts and outsourcing team as required and actively participate in the review and selection process of clinical vendors.
Ensure adherence to business processes with respect to vendor contracts and invoicing procedures.
Serve as key liaison with project and site management clinical research organizations (CROs) and monitor and track adherence to contracts and budgets.
Participate in trial budget reviews and invoice reconciliation.
Quality and Process Improvement:
Participate in development and review of clinical SOPs.
Maintain 100% compliance with SOP training.
Conduct audits and inspection readiness visits to investigator sites and vendors
Work closely with management and functional areas outside of clinical to influence processes and program decisions while driving business process improvement initiatives.
Education: BA/BS in Biological Sciences or related field
At least 78 years of work experience in the pharmaceutical and/or drug development industry.
Experience with management of clinical research organizations or drug development partnership relationships.
Thorough understanding of and experience with the drug development process through multiple study phases (e.g. Phases I through IV).
Registration and regulatory response experience.
Previous management experience in leading a team of people to deliver an objective
Practical experience in initiating, maintaining and terminating clinical trials in the role of clinical operations/development within industry.
Practical experience performing project management for a cross-functional project
Experience managing remote employees, may be matrix management experience.
Experience with development of prospective site-selection criteria, site documents and study set-up.
Practical experience in initiating, maintaining and terminating clinical trials.
Experience with management of CROs or other vendor relationships.
Experience with reviewing adequacy of site/clinical-proposed documents for compliance with relevant regulations
Protocol development experience
Ability to deal with time demands, incomplete information or unexpected events
Skills and Attributes:
- Attention to detail
Equal Opportunity Employer