Executive Director, Data Management

The Executive Director of Data Management will be responsible for leading and managing the strategic and operational aspects of data management in the support of Clinical Development functional activities, including database build, database lifecycle management, data review, vendor management and oversight across all Elicio studies and programs. The Executive Director will manage the company program-wide database infrastructure, ensuring efficiency and consistency where possible, review trends and implement strategy for data collection improvements. They will also implement data privacy compliance measures as required for each clinical trial.

This position will ensure that all data collection is per protocol(s), in accordance with all necessary regulations and aligned across Clinical, Clinical Development and Biometrics needs in support of ad hoc, protocol and regulatory deliverables. The Executive Director will work closely with key stakeholders including Clinical, Clinical Operations, and Biometrics, as well as other

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

Major Duties/Responsibilities

• Establish and provide leadership of the Data Management team by providing expertise and guidance to the clinical development team regarding data standards, data quality, validation, integration with regulatory requirements
• Develop Data Management Departmental SOPs and ensure staff adherence to company policies, SOPs, and regulatory requirements
• Oversee all aspects of the Data Management and Clinical Programming teams including resource planning, deliverables, hiring, staff training, staff appraisals, performance reviews, and annual salary reviews
• Oversee and/or provide clinical study level data management oversight of outsourced clinical trials including project management, vendor management, coordination of internal reviews, and oversight/approval of deliverables.
• Author/review eCRFs, CCGs, and Data Management Plans. Assist as needed with clinical documents such as clinical protocols, Investigator Brochure updates, and regulatory reporting updates
• Lead database design and production, ensuring that CROs, vendors and internal staff meet the required quality standards
• Review data analysis listings and report on performance and quality with expertise in metrics/KPI analysis; review clinical data within studies and across programs for trend analysis
• Act as liaison with CROs and third-party data vendors, as needed, for data management organization.
• Collaborate with the internal functional leads to ensure all stakeholders’ needs are addressed and communicate project status and issues.
• Responsible for instructing the implementation of new or advanced systems, processes and resources to increase productivity
• Responsible for department resourcing and budget/budget forecasting
• Guide data management activities for regulatory submissions
• Other projects and responsibilities as needed

Education & Professional Experience

Required:

• Minimum of a B.S. in related field with 15 years of Data Management within the biotechnology/pharmaceutical industry with detailed knowledge of data management platform and software, clinical trial databases, CDISC standards and pharmaceutical drug development process.
• 10 years of proven management experience
• Knowledge of FDA requirements, including ICH GCP guidelines, and other applicable regulations and practices, including data privacy regulations and implementation as related to data systems and data collection.
• Experience in regulatory inspections is a plus
• Knowledge of submission requirements, (e.g. NDA, BLA, and MAA)
• Experience managing and mentoring personnel.

Skills

• Ability to prioritize and manage through complex processes/projects.
• Proven strong data management skills with focus on executing deliverables and on timelines.
• 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.
• Flexible and creative to meet the needs of a growing, dynamic company.
• Successfully able to manage clinical data management vendors, contractors and service providers
• Good analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development

Working Conditions: Busy office/laboratory environment with frequent deadlines and interruptions

Travel: Travel is not required

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

Work Location: This role can be remote (employees near Boston are welcome to come onsite, though it is not a regular requirement)

About Elicio Therapeutics

Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing a pipeline of novel lymph node-targeted immunotherapies for the treatment of some of the most aggressive cancers. By combining expertise in immunology and immunotherapy, Elicio is harnessing the natural power of the immune system with the AMP technology, which allows for therapeutic payloads to be delivered directly to the lymph nodes, with the goal of enhancing the immune system’s cancer-fighting capabilities. By targeting cancer immunotherapies to the core of the immune response, AMP aims to optimize the lymph nodes’ natural ability to educate, activate and amplify cancer-specific T cells, which are essential for recognizing and eliminating tumor cells. Engineered to synchronize immunity in these highly potent sites, AMP is built to enhance the magnitude, potency, quality and durability of the immune response to drive antitumor activity. The Company’s R&D pipeline includes off-the-shelf therapeutic cancer vaccines ELI-002, (targeting mKRAS-driven cancers) as well as ELI-007 and ELI-008 (targeting BRAF-driven cancers and p53 hotspot mutations, respectively). For more information, please visit www.elicio.com.

About the Amphiphile Platform

Elicio Therapeutics’ proprietary Amphiphile (“AMP”) platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, Elicio has observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based upon preclinical studies. Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships. The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, Elicio has observed lymph node-specific engagement driving immune responses of increased magnitude, function and durability.