Director, Clinical Operations

Immunomic Therapeutics•Rockville, MD

20d•$190,000 - $210,000•Hybrid

About The Position

Immunomic Therapeutics, Inc. (ITI) an HLB Company, is a privately-held, clinical-stage biotechnology company pioneering the development of vaccines through its proprietary technology platform UNITE®, which is designed to utilize the body's natural biochemistry to develop vaccines that generate broad immune responses. ITI is primarily focused on applying the UNITE® platform to oncology indications, where it could potentially have broad applications, including development of antigen-derived antibodies as biologics in several cancers. The company has built a pipeline leveraging UNITE® with programs in oncology, animal health, infectious disease, and allergy. Immunomic Therapeutics is growing our clinical team and are seeking a strategic and tactical Director of Clinical Operations to help advance our programs. The Director of Clinical Operations is responsible for providing leadership to ITI's programs and ensuring studies (Phase I-IV) are compliant with company goals, procedures, FDA regulations, GCP, ICH requirements and any other applicable regulations. The Director is also responsible for the development and implementation of clinical operations standards and applying best project management practices and incorporating continuous sponsor oversight to facilitate trial initiating, planning, executing, monitoring/controlling, and closing activities.

Requirements

Bachelor's degree in a scientific or health-related field is required.
Minimum of twelve years of clinical research experience, including on-site monitoring experience.
Minimum of eight to ten years of experience in the management of clinical trials as a project manager or other relevant experience at a pharmaceutical/biotech company or CRO.
Minimum of four to six years of prior supervisory experience required.
Advanced understanding of GCPs, FDA regulations and ICH guidelines required.
Must be proficient in MS Office Suite with expertise in MS Project or equivalent Project.
Must be proficient with Clinical Trial Management Systems.
Project Management experience required, including experience managing clinical programs, budgets and timelines

Nice To Haves

Master's degree in a scientific or health-related field is highly preferred.
Therapeutic area experience in multiple therapeutic fields preferred. Provides leadership in the development of monitoring strategy for all clinical trials.
CRA or another clinical research certification preferred, but not required for role
PMP certification preferred.

Responsibilities

Collaborates with the leadership team to ensure alignment of resources and budgets across clinical programs by establishing and managing program timelines and priorities.
Provides leadership in the development of the clinical trial vendor and site management, budget, and resourcing strategies at a clinical program level.
Participates in the development of clinical regulatory documents for filing with the FDA (e.g., IND submissions, IND annual reports, and expedited safety report and NDA/BLA).
Participates and/or leads continuous improvement initiatives and collaborates in the development of Clinical Operations Standard Operating Procedures (SOP), Work Instructions (WI), training and other tools to ensure compliance with FDA Regulations.
Manages all study vendors to identify, map and plan critical process parameters and quality control mechanisms to oversee clinical study initiating, planning, executing, monitoring/controlling, and closing activities encompassing project management, data management, monitoring, biostatistics, medical writing, laboratory kit builds, assay runs, and investigational product (IP) packaging, labeling, storage, and distribution are completed on time, within budget, in compliance, and maintain inspection readiness.
Establishes study milestones and ensures accurate tracking and reporting of study metrics.
Leads internal and external resources to achieve deliverables aligned with clinical program and company goals.
Leads vendor identification and selection, including but not limited to Request for Proposal (RFP) development, proposal review, collaboration with potential vendors to refine proposal assumptions, preparing quote compilation for comparison of tasks/costs, negotiation of costs and contracting.
Responsible for overseeing contracted efforts with investigational sites, contract research organizations (CROs), clinical laboratories, research consultants and other vendors or external suppliers providing research-related services.
Works with QA on preparing and conducting vendor and site audits.
Provides clinical program updates, including trial status/metrics, budget, accomplishments, and risks to the leadership team.