Director of Clinical Operations

Job title: Director of Clinical Operations

Reports to: Chief Development Officer

FLSA Status: Full Time (Non-Exempt)

Job Overview

Imagion Biosystems, Inc. is developing medical imaging technologies based on high sensitivity detection of magnetic nanoparticles for in vivo detection of cancer, and other human diseases. Our lead product candidate, the MagSense® HER2 imaging agent, is currently being evaluated in a Phase 1 clinical study in patients with Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer.  We are looking for a motivated and experienced clinical operations leader to help us establish, improve and manage our clinical capabilities to conduct early feasibility, proof of concept and pivotal trials of our development candidates in US, EU, Australia and other countries.  The clinical operations leader will be a key member of the clinical leadership team and is responsible for all aspects of planning, operationalization and completion of Imagion’s clinical studies. He/she will play a key role in assisting the Chief Development Officer in building Imagion’s clinical organizational functions, structure, resources, systems and processes. Candidates must be proficient with good clinical practices (GCP) and have significant experience working with US FDA regulations for developing medical devices and/or pharmaceutical or combination product. Experience in managing studies outside the U.S. will be considered a plus. The ideal candidate will be self-directed, deadline-driven, detail-oriented, and comfortable working in a fast-paced interdisciplinary team environment. The responsibilities, experience and skill levels detailed below is for the Director level position; however, we will consider strong candidates with intermediate-level skills and experience at the Associate Director or Sr. Clinical Program Manager level.

Primary Duties and Responsibilities

The Director of Clinical Operations is responsible for the creation, execution and management of clinical study operational strategy, plan, execution and coordination between Imagion, CROs and clinical sites.

    • Develops clinical study execution and study management plans for Imagion’s medical technology clinical programs consistent with product candidate’s clinical /regulatory strategy and development plan.  This includes the development of operational plan, risk assessments, detailed timelines, resource needs, budget planning, progress and performance tracking metrics that aligns with the overall project goals.
    • Provides oversight for the conduct of the clinical trials. Leads and drives the execution of clinical trial from study start up to termination and close, including the collection of feasibility information, site /investigator recruitment/selection, study start-up, recruitment strategies and timely enrollment, data collection, clinical supply management, and reports management, monitoring, cleaning, close out.
    • Responsible for evaluating, recommending and recruiting clinical trial and biometrics CROs, clinical databases and the associated resources infrastructure for transitioning medical technology products from phase 1 through pivotal clinical trials.  Manages the study CROs in executing the ongoing trials as well as identification, selection and management of any new CROs as needed in the future.
    • Ensures that clinical trials are executed in compliance with the ICH/GCP, Regulatory Authorities regulations/guidelines. Maintains awareness and education with regard to relevant regulations, guidelines and best practices for conduct of clinical trials.
    • Determines the operational processes, systems and standards that need to be adopted and implemented consistently to support compliance across trials (e.g. SOPs, best practices, TMF, training programs). Works with QA in the development of SOPs and processes and audits.
    • Drives the planning /forecasting and reviews of clinical study budgets and change orders, executes trial to ensure completion in accordance with company’s goals and objectives within the agreed upon budget, timelines and quality metrics, provides timely updates on progress and changes in scope, schedule, and resource needs.
    • Initiates and coordinates the process for drafting clinical study reports, investigators brochures, protocols, case report forms, study monitoring plans and other regulatory documents (e.g., IDE, IND, annual reports, briefing books etc.) in conjunction with Medical Writing and relevant authors. Provides clinical operations review and input into these documents.
    • Responsible for planning and building the Clin Ops resources: selects, trains and manages staff (full time or contractors) including Clinical Research Associates and Clinical Trial Managers.
    • Plans and leads study management team meetings, prepares agenda, meeting minutes and tracks action items.
    • Coordination, oversight and document support as needed for safety data reviews, safety reporting and pharmacovigilance activities

Knowledge, Experience and Skills:

    • Bachelor’s degree in health sciences, scientific or equivalent disciplines required. Advanced degree highly desirable.
    • Ten (10) plus years experience in clinical operations including 5 plus years of line management and 5 plus years of clinical operations leader or clinical program manager responsibility in medical technology or biotech or pharma environment; strong oncology therapeutic experience.
    • Demonstrated excellence in clinical trial management including project management for multiple projects/priorities and budgets.
    • Proven ability to build a clinical operations team and study management infrastructure from the ground up; prior experience in working in startup fast paced, limited resource company environment.
    • Proven experience in CRO/vendor selection, contracting, oversight and relationship management.
    • Well-versed with global pharmaceutical or device/combination product regulatory requirements and strategic implications for clinical operations; includes understanding of clinical research principles, drug development process, FDA & ICH, GCP and related regulatory requirements & guidelines.
    • Strong verbal and written communication skills; operates independently and effectively in multi-study, multi-disciplinary atmosphere in a matrix environment.
    • Strong computer skills including knowledge of Microsoft Excel, Word, PowerPoint, Outlook and Project
    • Position will be based in Imagion’s San Diego office. Local candidates highly preferred. Remote candidates willing ~30% potential travel are welcome to apply.
    • Legally authorized to work in the United States

About Imagion Biosystems

Imagion Biosystems, Inc. is developing an innovative functional imaging technology for cancer detection using superparamagnetic relaxometry (SPMR). Our MagSense® system has been designed to detect cancer and other diseases using the magnetic signature of our biofunctionalized PrecisionMRX® nanoparticles.  This detection platform is expected to offer greater sensitivity and specificity than is currently possible with other clinical imaging modalities.

To apply for this position, please complete the application HERE.