Director Clinical Operations

Company Description

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.

Role Description

This is a full-time on-site role for a Director of Clinical Operations who would be 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.

RESPONSIBILITIES: (essential functions required to be performed by the incumbent):

Program management:

·        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.

Project management:

·        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.

ORGANIZATIONAL RELATIONSHIPS: (describe complexity of internal and external relationships in the performance of the position)

·        Will interact primarily with the leadership team internally and with various vendors requiring professionalism, the ability to understand unique cultural aspects of each organization he/she will be interacting with.

SUPERVISION: (describe the nature of supervisory responsibilities)

·        This position may supervise associates in Clinical Operations.

QUALIFICATIONS: (minimum education level and years of job-related knowledge and skills required to meet the expectations of the position):

·        Bachelor's degree in a scientific or health-related field is required.

·        Master's degree in a scientific or health-related field is highly preferred.

·        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.

·        Therapeutic area experience in multiple therapeutic fields preferred. Provides leadership in the development of monitoring strategy for all clinical trials.

TECHNICAL/BEHAVIORAL SKILLS/COMPETENCIES: (minimum required to meet the expectations of the position)

·        Customer Focus

·        Communication/Presentation Skills (spoken, written)

·        Integrity/Ethics

·        Initiative

·        Sense of Urgency

·        Teamwork

·        Collaboration Skills

·        Innovation

·        Must be proficient in MS Office Suite with expertise in MS Project or equivalent Project.

·        Must be proficient with Clinical Trial Management Systems

·        PMP certification preferred.

PHYSICAL REQUIREMENTS: (i.e., lifting, standing, visual)

·        Significant sitting and computer usage for long periods of time. Ability to lift 10 pounds.

WORK ENVIRONMENT: (mental demands and other working conditions, such as hot/cold temperatures, exposure to chemicals and biohazards etc.)

• Hybrid, 3 days in the office/week required

Position Type and Expected Hours of Work

• This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m.

This position requires travel; the average travel for this position is 5-10% with some variation based upon business needs.

Salary Range: $190K-$210K