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Elicio Therapeutics
Boston, Massachusetts, United States (hybrid)
11 days ago
Elicio Therapeutics
Boston, Massachusetts, United States (hybrid)
11 days ago

Description

Reporting to the Senior Vice President of Clinical Development, the Executive Director of Clinical Operations is responsible for the management of clinical trial(s) for a given product within the Elicio portfolio. The role will be responsible for the mentoring and management of other clinical operations staff assigned to clinical trials within the program.  The primary focus for the Executive Director will be the execution of operational strategy for the lead product candidate by the assigned clinical operations team, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance. 

Elicio is a growing organization based out of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States. 


This position allows for hybrid or fully remote work depending on proximity to office

Major Duties/Responsibilities

  • The Clinical Operations program lead for the assigned program(s).
  • Develops program strategy in collaboration with the SVP of Clinical Operations
  • Maintains budget, including planning/forecasting, and clinical trial metrics for assigned clinical program.
  • Attends Clinical Operations senior leadership meetings and maintains close communication with other Clinical Operations senior staff to support knowledge sharing across department.
  • Provides leadership, including mentoring, management and support to staff assigned to program to ensure all clinical trials within the program are operationalized and managed in alignment with strategy and compliance standards.
  • Oversees all activities of assigned Clinical Operations team in clinical trial management (from study start up to study closure), including vendor and site start-up, ongoing trial management and quality/risk management evaluation.
  • Contributes to clinical trial design and implementation planning to ensure optimized clinical development plans for assigned projects.
  • Provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
  • Oversees management of cross-functional study team meetings to ensure adherence to Elicio trial strategy, proactive communication of clinical trial updates, metrics and issues for all aspects of the trial(s) and program
  • Leads program risk mitigation and escalation activities both internally as well as with sites and vendors.
  • Ensures consistency of process across studies within assigned program as appropriate and works with Clinical Operations leadership to bridge across programs as needed
  • Coordinates the team operations with internal and external collaborators (cross-functional project team and study vendors) to ensure operational excellence.  Serves as program oversight lead for the contract research organizations (CROs), vendors and clinical sites involved in the clinical trials.

Education & Professional Experience

Required:

  • A minimum of a BS or RN is required, with at least 10 years’ experience in clinical operations management (at least 5 years at program-level management) within a pharmaceutical or biotechnology organization.
  • Experience managing Phase I-III clinical trials.
  • Experience in immune-oncology highly preferred.
  • Proven strong clinical trial management skills (study start up through closure) with focus on executing to deliverables and timelines.
  • Excellence managing and mentoring personnel. Focus on fostering a culture of teamwork.
  • Robust knowledge of ICH GCP guidelines, and other applicable regulations and practices.
  • Working knowledge, understanding and application of principles, concepts and practices of clinical research is required.
  • Excellent communication, organizational, negotiation and interpersonal skills required.
  • Effective in promoting and maintaining productive internal and external relationships.  Proven leadership and team building skills, along with success in proactive risk mitigation and problem solving.
  • Experience working in a small biotech environment, including ability to work with management as well as peers and direct reports
  • Flexible and creative to meet the needs of a growing, dynamic company. 

Working Conditions

Busy office environment with frequent deadlines and multiple responsibilities.  Ability to effectively multi-task is advantageous.

Travel: Travel is required less than 15% of the time

Physical Requirements: Subject to periods of sitting or standing, vision is required to monitor data.

To Apply: Please submit your resume to careers@elicio.com using the job title in the email subject line.

About Elicio Therapeutics

Elicio Therapeutics is advancing the Amphiphile technology across immunotherapy platforms to defeat cancers and infectious diseases. By combining expertise in materials science, immunology, and immuno-oncology, Elicio is engineering potent Amphiphile immunotherapies that precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated.  Elicio is engineering lymph node targeted cell therapy activators, immunomodulators, adjuvants and vaccines for an array of aggressive cancers and infectious diseases. The Amphiphile platform emerged from laboratories of Darrell Irvine, Howard Hughes Investigator and Professor of Biomedical Engineering in the Koch Institute of Integrative Cancer Research at MIT. For more information, please visit https://elicio.com.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the “brain center” of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence.  Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease.  This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms.  By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses.  This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.



Job Information

  • Job ID: 65633368
  • Workplace Type: Hybrid
  • Location:
    Boston, Massachusetts, United States
  • Position Title: Executive Director, Clinical Operations
  • Company Name For Job: Elicio Therapeutics
  • Job Function: Clinical,
    Executive,
    Program Management
  • Job Type: Full-Time
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