Job Description

Are you ready for an exciting leadership opportunity in molecular imaging research?

The Nuclear Imaging Institute (NII) in Bergen County, NJ, seeks a Clinical Trial and Regulatory Affairs Manager to join our growing research team.

If you are a highly organized, detail-oriented professional who finds yourself frustrated by a lack of purpose, or drained by the rigid bureaucracy of larger organizations, this role offers a refreshing alternative. At NII, you will be engaged across the entire clinical trial continuum - from early concept through execution - while shaping processes in a lean, collaborative environment where your contributions have visible impact.

Here, your skills won’t be lost in the shuffle—you’ll have the chance to drive innovation, influence strategy, and be an integral part of building something new in the fields of molecular imaging, neuroscience, and oncology.

About Us

The Nuclear Imaging Institute (NII) is at the forefront of molecular imaging and radiopharmaceutical innovation. We are conducting multiple FDA-regulated clinical trials in advanced ultralow dose Positron Emission Tomography (PET) imaging with the goal of revolutionizing molecular imaging to increase health span and facilitate healthy aging.

We are seeking a highly skilled and experienced Regulatory Affairs and Clinical Trials Manager to lead the regulatory and operational execution of our clinical trials. This individual will work directly with the Executive Director/Principal Investigator and will play a pivotal role in ensuring the initiation, regulatory integrity, compliance, and success of our expanding clinical research portfolio.

Key Responsibilities

Clinical Trial Oversight

• Guide protocol and informed consent development, ensuring compliance with FDA and ICH-GCP requirements.
• Oversee trial start-up activities, including site regulatory packages, 1572s, investigator CVs, financial disclosures, and radiation dosimetry filings.
• Coordinate ClinicalTrials.gov registrations and updates.
• Support PI in vendor and CRO oversight for regulatory deliverables.

Compliance & Quality Management

• Develop and maintain SOPs, policies, and regulatory templates to ensure consistency and compliance.
• Oversee essential regulatory documents and maintain complete and accurate electronic Trial Master File (TMF).
• Ensure timely and compliant SAE/AE reporting to FDA and IRBs.
• Prepare for, support, and lead audits and inspections (FDA, sponsor, or institutional).

Regulatory Strategy & Submissions

• Lead preparation, submission, and maintenance of FDA INDs, eINDs, IDEs, and amendments.
• Prepare and manage annual reports, safety reports, and DSURs.
• Serve as point of contact for FDA, IRBs, DSMBs, and Collaborators.
• Draft, review, and finalize briefing documents, meeting requests, and agency correspondence.

Leadership & Collaboration

• Partner with PI, clinical coordinators, imaging technologists, radiopharmacy, and data teams.
• Train staff and investigators on regulatory processes and GCP compliance.
• Manage and coordinate external consultants and CRO partners.

Qualification

• Advanced degree required: PhD, MD, PharmD, MPH, or Master’s Degree in a relevant field.
• Progressive experience in clinical research, with proven expertise in FDA IND projects.
• Strong knowledge of ICH GCP, FDA/EMA regulations, clinical trial design, and regulatory strategy.
• Experience in molecular imaging, or radiopharmaceuticals preferred, but not necessary.
• Exceptional organizational, communication, and writing skills.

Why Join Us?

• Enable cutting-edge innovation – Play a pivotal role in advancing first-in-human and exploratory IND studies using next-generation imaging and radiopharmaceutical technologies.
• Shape the future – Enjoy autonomy, intellectual freedom, and the opportunity to drive big-picture regulatory strategy in a rapidly growing research institute.
• Make an impact – Contribute to transformative work at the intersection of neuroscience, oncology, and molecular imaging, improving diagnostics and patient care.
• Collaborate with leaders – Work side-by-side with world-class investigators and clinical partners on groundbreaking clinical trials.
• Lead with purpose – Define and oversee regulatory processes that set the foundation for cutting-edge clinical research programs.
• Be rewarded – Competitive salary, commensurate with experience and impact.

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