Senior Clinical Trial Leader – Oncology

Alentis Therapeutics

. Act as the primary Clinical Operations and/or Clinical Science lead and the face of Alentis towards external vendors, CROs, investigators, and study partners .

Posted 10/30/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in leading global clinical trials, including strategic oversight, regulatory compliance, and stakeholder management. Proficient in clinical study management, budgeting, and risk mitigation within the biotechnology sector.

Highest-signal resume keywords

Global Clinical Trial LeadershipClinical Data Signal DetectionProject ManagementRegulatory Compliance (ICH-GCP)Stakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementClinical Trial BudgetingRisk ManagementRegulatory SubmissionsData Management PlansStatistical Analysis PlansStudy Protocol DevelopmentVendor SelectionFeasibility AssessmentsContinuous Improvement

Soft Skills

LeadershipCommunicationPresentationOrganizational SkillsInfluencing

Tools & Technologies

(e)TMFClinical Trial Management Systems

Industry Keywords

BiotechnologyOncology Drug DevelopmentGCPHealth AuthoritiesCRO ManagementClinical OperationsClinical ScienceStudy Close-OutInspection ReadinessCAPA Management

About the role

Key responsibilities & impact

Act as the primary Clinical Operations and/or Clinical Science lead and the face of Alentis towards external vendors, CROs, investigators, and study partners
Lead and oversee the preparation, execution, and delivery of complex global clinical trials
Provide strategic leadership and operational oversight for one or more clinical studies and support cross-study alignment across development programs
Coordinate the development, review, and approval of study 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 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 feasibility assessments, contribute to vendor selection and contract negotiations, and oversee vendors
Plan and lead Investigator Meetings, vendor meetings, and study-specific training
Ensure delivery of studies within planned timelines, quality expectations, and approved budgets
Oversee monitoring activities and review study performance metrics for data integrity, protocol compliance, and patient safety
Identify operational risks, develop mitigation plans, and escalate critical issues
Support inspection readiness, audits, inspections, and CAPA management
Ensure study documentation is inspection-ready and archived within the (e)TMF
Oversee database lock, study close-out, and study reporting activities
Provide Clinical Science and/or Operations input into the Clinical Development Plan and broader program planning
Drive 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 procedures

Requirements

What you’ll need

Master's degree or equivalent university degree in Life Sciences, Healthcare, Pharmacy, or a related field
≥8 years of clinical study management experience, including early-phase clinical trials, preferably within biotechnology and global development environments
Demonstrated expertise in global clinical trial leadership, clinical data signal detection, project management, and risk management
Experience leading complex, multinational clinical studies and managing multiple stakeholders across countries, functions, and vendors
Strong understanding of the oncology drug development process from First-in-Human through later-stage clinical development
Advanced knowledge of current clinical trial regulations and guidelines, including ICH-GCP
Proven experience in 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
Fluent in English; additional languages are advantageous
Ability and willingness to travel internationally
Proactive, solution-oriented, and capable of operating effectively in a fast-paced biotech environment with an entrepreneurial mindset
Candidates must hold valid US work authorization or be US citizens

Benefits

Comp & perks

At-will employment
40 hours/week
International travel opportunity
Mentorship and guidance opportunities
Contribution to advancing new medicines for patients