Senior Clinical Trial Leader – Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the primary lead for Clinical Operations and/or Clinical Science, representing Alentis to external vendors, CROs, investigators, and study partners.

• Direct and manage the preparation, execution, and successful completion of complex global clinical trials.

• Provide strategic direction and operational oversight for one or more clinical studies while fostering cross-study alignment across development programs.

• Coordinate the preparation, review, and approval of study-related documents, including protocols, ICFs, guidelines, regulatory documents, monitoring plans, data management plans, statistical analysis plans, and clinical study reports.

• Contribute to regulatory submissions and responses to Health Authorities, ECs/IRBs, DSMBs, and various regulatory bodies.

• Collaborate with clinical development physicians on safety data monitoring and signal detection.

• Oversee the forecasting and planning of IMPs, ancillary supplies, and study materials.

• Assess feasibility, assist in vendor selection and contract negotiations, and supervise vendors.

• Plan and conduct Investigator Meetings, vendor meetings, and study-specific training sessions.

• Ensure the timely delivery of studies that meet quality standards and adhere to approved budgets.

• Supervise monitoring activities and evaluate study performance metrics for data integrity, protocol adherence, and patient safety.

• Identify operational risks, formulate mitigation strategies, and escalate critical issues as necessary.

• Facilitate inspection readiness, manage audits, inspections, and CAPA processes.

• Ensure that study documentation is prepared for inspection and properly archived within the (e)TMF.

• Oversee database locking, study closure, and reporting activities.

• Provide insights from Clinical Science and/or Operations into the Clinical Development Plan and broader program strategies.

• Promote continuous improvement and contribute to clinical processes, standards, and SOPs.

• Mentor Clinical Trial Leads, Clinical Trial Managers, and cross-functional study team members.

• Maintain appropriate training and compliance with regulations, GCP, and company protocols.

⛳️ Requirements

• Master's degree or an equivalent university qualification in Life Sciences, Healthcare, Pharmacy, or a related field.

• A minimum of 8 years of clinical study management experience, including early-phase clinical trials, ideally within biotechnology and global development contexts.

• Proven expertise in leading global clinical trials, clinical data signal detection, project management, and risk management.

• Experience in managing complex, multinational clinical studies and engaging multiple stakeholders across diverse countries, functions, and vendors.

• Strong comprehension of the oncology drug development process from First-in-Human through later-stage clinical development.

• Advanced understanding of current clinical trial regulations and guidelines, including ICH-GCP.

• Demonstrated experience in selecting, managing, and supervising CROs and external service providers.

• Strong grasp of clinical trial budgeting, forecasting, and resource allocation.

• Proven leadership, influencing, and stakeholder management capabilities.

• Exceptional communication, presentation, and organizational skills.

• Fluent in English; proficiency in additional languages is a plus.

• Willingness and ability to travel internationally.

• Proactive, solution-focused, and capable of thriving in a dynamic biotech environment with an entrepreneurial approach.

• Candidates must possess valid US work authorization or be US citizens.

🏝️ Benefits

• At-will employment.

• 40 hours per week.

• Opportunities for international travel.

• Mentorship and guidance opportunities.

• Contribution to the advancement of new medicines for patients.