Sobre o nosso cliente
Biotech Pharmaceutical Company.
Descrição
1. Lead and manage relationships with Business Development Manager for antibody and CAR-T cell therapy customers;
2. Oversee trial execution, ensuring timelines, budgets, and quality metrics are met;
3. Work closely with BD, R&D, clinical, market access, and regulatory teams to align trial objectives with the customers' needs and goals;
4. Ensure compliance with INFARMED, FDA, EMA, and other global regulatory requirements;
5. Manage vendor selection, contract negotiations, and performance evaluation of CRO partners.
Perfil ideal
1. Bachelor's degree in Life Sciences, Immunology, Biotechnology, or a related field (Master's or PhD preferred).
2. 5+ years of experience managing CROs in Biologics, Antibody, or Cell Therapy Clinical Trials;
3. In-depth knowledge of CAR-T cell therapies and antibody development processes.
4. Experience in Laboratory management;
5. Experience working with regulatory authorities like the FDA and EMA for the submission of clinical data and trial approvals;
6. Experience in leading cross-functional teams and managing complex projects across multiple stakeholders;
7. Excellent communication and interpersonal skills to work effectively with Academy, R&D, regulatory, medical, market access, and operational teams;
8. Strong project management, negotiation, and communication skills.
Vantagens
Excellent opportunity to join an ambitious project, being part of a team that wants to revolutionize cancer treatment. Apply and help advance the next generation of therapies!
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