Study Start-Up Manager- Nuclear Medicine Oversight (Remote Position)

Job Description Summary

This position is primarily designed to provide strategic and operational support for the implementation of clinical studies involving Radioligand Therapy (RLT) across the US. While formally structured as an SSU Manager role, it does not include regulatory or traditional study management responsibilities. The focus is to serve as a dedicated resource for the expansion and enablement of RLT studies, considering the varying levels of experience and readiness across the region.

LI-#Remote

Internal title : SSO Study Start-Up Manager

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and / or international) will be defined by the hiring manager

Job Description

Key Responsibilities :

Support the mapping and structuring of Central Radiopharmacies in the US, including vendor qualification and contract negotiation support.

Support the contracting of specialized vendors and provide legal coordination for technical agreements and contracts.

Act as a regional point of contact for nuclear medicine infrastructure, including equipment, suppliers, and radiolabeling processes.

Collaborate with local and global stakeholders to ensure the technical and operational feasibility of RLT studies.

Identify gaps and propose solutions to enhance the country's readiness and capacity for conducting radiopharmaceutical studies.

Assist studies in securing RLT supplies, supporting with vendor process excellence during Study Start-Up (SSU) and throughout trial conduct.

Partner with SSU, Clinical Operations, Legal, Quality, Procurement and Regulatory Affairs teams, without assuming direct responsibilities from these areas.

Contribute to the development of regional playbooks, procedures and best practices for RLT studies.

Oversight of selection, qualification, & management of RP (both central and site) activities

Oversight of management of nuclear medicine equipment related tasks (i.e. Dose Calibrator calibrations, Gamma Counter calibrations, SPECT / CT qualifications, PET / CT qualifications, procurement of equipment)

Essential Requirements :

BS / BA Degree in Pharmacy, Biomedicine, Biomedical Engineering, Medical Physics, or related fields.

Solid knowledge of radiopharmacy and nuclear medicine, including cold kit radiolabeling processes and operation of equipment such as gamma cameras, PET / CT, and hot cells.

Familiarity with local and international regulations applicable to radiopharmaceuticals

Experience in mapping and qualifying technical and logistical vendors for radiopharmaceutical studies.

Understanding of importation, transportation, and storage processes for radioactive materials.

Ability to read and interpret technical documents, including product dossiers, safety data sheets, clinical protocols, and technical contracts.

Basic knowledge of compliance and quality standards relevant to clinical studies involving radioactive products.

Strong stakeholder management skills with technical profiles, including clinical engineers, medical physicists, pharmacists, and nuclear medicine specialists.

The salary for this position is expected to range between $114,100 and $211,900 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here .

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$114,100.00 - $211,900.00

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model