The Senior Clinical Trial Leader Oncology acts as the face of Alentis towards external vendors and partners, fostering strong and collaborative relationships, and manages and executes all aspects of clinical trial preparation and conduct, ensuring high-quality delivery and compliance throughout the study lifecycle.

Tasks

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, ensuring adherence to timelines, budget, quality standards, and regulatory requirements.
Provide strategic leadership and operational oversight for one or more clinical studies and support cross-study alignment across development programs.
Contribute to and coordinate the development, review, and approval of study documents such as protocols, ICFs, study-specific guidelines, regulatory documents, monitoring plans, data management plans, statistical analysis plans, and clinical study reports, in accordance with internal SOPs and GCP requirements.
Contribute to the preparation of regulatory submissions and responses to Health Authorities, ECs/IRBs, DSMBs, and other regulatory bodies.
Contribute to the safety data monitoring and signal finding in collaboration with clinical development physicians.
Oversee forecasting and planning of IMP, ancillary supplies, and study materials to ensure uninterrupted study conduct.
Review and approve feasibility assessments (RFI, RFP), contribute to vendor selection, contract negotiations, and vendor oversight strategies.
Plan, organize, and lead Investigator Meetings, vendor meetings, and study-specific training activities.
Ensure delivery of studies within planned timelines, quality expectations, and approved budgets.
Oversee monitoring activities and review study performance metrics to ensure data integrity, protocol compliance, and patient safety.
Proactively identify operational risks and study challenges, develop mitigation plans, and escalate critical issues to senior management as appropriate.
Support and coordinate inspection readiness activities, audits, inspections, and CAPA management to ensure successful outcomes.
Ensure that study documentation is maintained, inspection-ready, and appropriately archived within the (e)TMF.
Oversee database lock, study close-out, and study reporting activities to ensure timely completion of clinical milestones.
Provide strategic Clinical Science and/or Operations input into the Clinical Development Plan and broader program planning activities.
Drive continuous improvement initiatives and contribute to the development and implementation of clinical processes, standards, and SOPs.
Mentor and provide guidance to Clinical Trial Leads, Clinical Trial Managers, and cross-functional study team members as appropriate.

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.
For the Basel workplace, candidates must hold a valid Swiss work permit or be EU citizens eligible to work in Switzerland. For the US workplace, candidates must hold valid US work authorization or be US citizens.

Contact

Doris Fink
Recruiter
Alentis Therapeutics AG