Senior Clinical Trial Leader – Oncology

🔥 14 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 15%

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Alentis Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $181.4M Series D on 2024-11

Biotechnology • Pharmaceuticals • Healthcare

Alentis Therapeutics is a clinical-stage biotechnology company (headquartered in Allschwil, Switzerland) developing anti-Claudin-1 antibody-drug conjugates (ADCs) and monoclonal antibodies to treat cancer and reverse organ fibrosis. Their pipeline includes clinical candidates such as ADC ALE. P02 for squamous cancers, ALE. P03, and the monoclonal antibody lixudebart (ALE. F02) for fibrosis; they emphasize targeted anti-Claudin-1 modalities to open stiff extracellular matrix, block disease signaling, and selectively kill tumor cells.

📋 Description

• 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

• 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

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

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