Director of Immuno-Oncology Clinical Trials

Overview The ideal candidate will lead the development and execution of clinical trials in immuno-oncology, ensuring timely delivery within budget and quality standards.

Responsibilities Design and oversee the clinical development plan for innovative and biosimilar portfolios, with a focus on immuno-oncology.

Lead scientific advice interactions with regulatory agencies to ensure compliance and validation of clinical trial plans.

Build and maintain relationships with Key Opinion Leaders (KOLs) to evaluate new pipeline opportunities and validate clinical trial plans.

Manage clinical trial budgets, including financial oversight of outsourced activities, to ensure optimal resource allocation.

Plan drug supply for clinical trials, coordinating with global logistics to ensure timely product availability.

Select, contract, and manage CROs and external vendors to ensure performance meets agreed cost, quality, and timeline standards.

Strategically identify countries, sites, and investigators for trial execution, optimizing scientific, regulatory, and operational feasibility.

Oversee the establishment and coordination of independent committees (IDMC, IRC, etc.), ensuring compliance and documentation for regulatory submissions.

Supervise the development and review of essential clinical trial documents (protocols, informed consent forms, amendments) in collaboration with medical and scientific teams.

Ensure timely regulatory and ethics approvals for clinical trials and protocol amendments, managing preparation and submission of required documentation.

Approve and monitor study monitoring plans and related interventions to ensure adherence to Good Clinical Practice (GCP).

Review and approve all study-related materials and operational guides to ensure accuracy and consistency.

Oversee site documentation and ensure compliance with local and international regulatory requirements.

Organize and lead investigator meetings to facilitate effective communication and collaboration with investigators and partners.

Supervise site files and conduct regular quality control checks to ensure GCP compliance and data integrity.

Ensure adherence to SOPs, GCP, and all applicable regulations in all assigned clinical trials.

Support Business Unit initiatives and ad hoc projects as needed.

Requirements Advanced degree in Health Sciences (MD, PharmD, PhD preferred).

Fluent in Spanish and English.

Minimum 6 years of experience in clinical research, with at least 3 years in leadership of international oncology trials.

Proven experience in budget management, team leadership, and vendor oversight.

Deep knowledge of international clinical trial regulations and Good Clinical Practice (GCP).

Willingness to travel internationally as required.

Strong strategic, organizational, and prioritization skills.

Ability to lead and motivate cross-functional teams.

Excellent analytical and communication skills.

Client-focused mindset and ability to work under pressure and meet tight deadlines.

Selection Process Initial contact by phone or email.

Two interviews (virtual and onsite).

Constant communication about the status of the process.

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