Study Start-Up Manager

Location: São Paulo (Brazil) OR Buenos Aires (Argentina).

This a SUU Manager position with focus on RLT, allocate in Brazil (São Paulo) or Argentina (Buenos Aires) this position is primarily designed to provide strategic and operational support for the implementation of clinical studies involving Radioligand Therapy (RLT) across Latin American countries. While formally structured as an SSU Manager role, it does not include regulatory or traditional study management responsibilities. In addition to SSU activities, this position 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.

Key Responsibilities:

• Support the mapping and structuring of Central Radiopharmacies in Latin American countries, 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.

Technical Competencies:

• 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.

Qualifications:

• Bachelor's degree in Pharmacy, Biomedicine, Biomedical Engineering, Medical Physics, or related fields;
• Previous experience in clinical research, preferably with exposure to projects involving radiopharmaceuticals or nuclear medicine;
• Fluent in English.

Ideal Profile:

• Proactive, with strong problem-solving and stakeholder engagement skills;
• Strategic mindset and ability to navigate complex and ambiguous environments;
• Passion for innovation and the development of new therapies;
• Ability to bridge technical and operational domains effectively.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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Division

Development

Business Unit

Innovative Medicines

Location

Brazil

Site

Ramallo (Argentina)

Company / Legal Entity

BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A

Alternative Location 1

Santo Amaro, Brazil

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No