Job Description
We are seeking a highly experienced professional to lead our Biotech Pharmaceutical Company's Clinical Operations team.
Key Responsibilities:
* Lead and manage relationships with Business Development Managers for antibody and CAR-T cell therapy customers;
* Oversee trial execution, ensuring timelines, budgets, and quality metrics are met;
* Work closely with cross-functional teams to align trial objectives with customer needs and goals;
* Ensure compliance with INFARMED, FDA, EMA, and other global regulatory requirements;
* Manage vendor selection, contract negotiations, and performance evaluation of CRO partners.
Requirements:
* Bachelor's degree in Life Sciences, Immunology, Biotechnology, or a related field (Master's or PhD preferred);
* 5+ years of experience managing CROs in Biologics, Antibody or Cell Therapy Clinical Trials;
* In-depth knowledge of CAR-T cell therapies and antibody development processes;
* Experience in Laboratory management;
* Experience working with regulatory authorities like the FDA and EMA for the submission of clinical data and trial approvals;
* Experience in leading cross-functional teams and managing complex projects across multiple stakeholders;
* Excellent communication and interpersonal skills to work effectively with Academy, R&D, regulatory, medical, market access and operational teams;
* Strong project management, negotiation, and communication skills.
Benefits
This is an excellent opportunity to join an ambitious project and be part of a team that wants to revolutionize cancer treatment.