Senior Clinical Trial Leader Oncology

Alentis Therapeutics

About The Position

The Senior Clinical Trial Leader Oncology acts as Alentis’s primary Clinical Operations and/or Clinical Science lead and external-facing representative to vendors, CROs, investigators, and study partners. The role provides strategic leadership and operational oversight for complex global oncology clinical trials, managing preparation, execution, and delivery across the study lifecycle while ensuring compliance, quality, timelines, and budget expectations. The position contributes to clinical development and program planning, regulatory submissions, safety monitoring, vendor management, study documentation, and inspection readiness. It also supports continuous improvement of clinical processes and provides mentorship and guidance to clinical trial colleagues and cross-functional study teams.

Requirements

Master's degree or equivalent university degree in Life Sciences, Healthcare, Pharmacy, or a related field.
At least 8 years of clinical study management experience, including early-phase clinical trials; biotechnology and global development experience is preferred.
Expertise in global clinical trial leadership, clinical data signal detection, project management, and risk management.
Experience leading complex multinational clinical studies and managing stakeholders across countries, functions, and vendors.
Strong understanding of oncology drug development from First-in-Human through later-stage clinical development.
Advanced knowledge of current clinical trial regulations and guidelines, including ICH-GCP.
Experience selecting, managing, and overseeing CROs and external service providers.
Strong understanding of clinical trial budgeting, forecasting, and resource planning.
Demonstrated leadership, influencing, and stakeholder management skills.
Excellent communication, presentation, and organizational skills.
Fluency in English.
Ability and willingness to travel internationally.
Proactive, solution-oriented approach and ability to work effectively in a fast-paced biotech environment with an entrepreneurial mindset.
Valid US work authorization or US citizenship.

Nice To Haves

Experience in biotechnology and global development environments.
Additional languages.

Responsibilities

Act as the primary Clinical Operations and/or Clinical Science lead and the face of Alentis to external vendors, CROs, investigators, and study partners.
Lead and oversee preparation, execution, and delivery of complex global clinical trials in accordance with timelines, budgets, quality standards, and regulatory requirements.
Provide strategic leadership and operational oversight for one or more clinical studies and support alignment across development programs.
Contribute to and coordinate the development, review, and approval of study documents, including protocols, ICFs, study-specific 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 other regulatory bodies.
Contribute to safety data monitoring and signal finding with clinical development physicians.
Oversee forecasting and planning of IMP, ancillary supplies, and study materials.
Review and approve feasibility assessments (RFI, RFP), contribute to vendor selection and contract negotiations, and develop vendor oversight strategies.
Plan, organize, and lead Investigator Meetings, vendor meetings, and study-specific training activities.
Ensure studies are delivered within planned timelines, quality expectations, and approved budgets.
Oversee monitoring activities and review study performance metrics to support data integrity, protocol compliance, and patient safety.
Identify operational risks and study challenges, develop mitigation plans, and escalate critical issues to senior management as appropriate.
Support and coordinate inspection readiness, audits, inspections, and CAPA management.
Ensure study documentation is maintained, inspection-ready, and appropriately archived within the (e)TMF.
Oversee database lock, study close-out, and study reporting activities to achieve clinical milestones on time.
Provide strategic Clinical Science and/or Operations input into the Clinical Development Plan and broader program planning.
Drive continuous improvement and contribute to development and implementation of clinical processes, standards, and SOPs.
Mentor and guide Clinical Trial Leads, Clinical Trial Managers, and cross-functional study team members as appropriate.
Maintain appropriate training and ensure compliance with applicable regulations, GCP, and company procedures.