Clinical Trial Lead - US Based

Alveus Therapeutics is seeking a US based Clinical Trial Lead (CTL) to join our global R&D organization.

The CTL will be responsible for the end-to-end operational delivery of one or more US clinical trials, from study start-up through database lock and Clinical Study Report (CSR) completion. The CTL leads the cross-functional trial team and serves as the primary operational counterpart to the selected CRO, ensuring execution excellence in a lean, fast-moving biotech environment.

This role requires strong matrix leadership, hands-on operational expertise, and the ability to drive clarity, momentum, and accountability across internal and external stakeholders. The CTL thrives in ambiguity, brings a pragmatic and solutions-oriented mindset, and consistently delivers high-quality trials on time and within budget.

Required Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, PharmD, PhD, MD or equivalent) preferred.
• 10+ years of clinical operations experience within biotech or CRO environments.
• Extensive hands-on experience leading Phase 1 and early Phase 2 trials.
• Proven track record of independently delivering clinical trials from start-up to CSR.
• Strong experience in CRO oversight and vendor management within outsourced models.
• Experience in small or emerging biotech companies strongly preferred
• Deep knowledge of clinical trial execution and global regulatory requirements (ICH-GCP, FDA).
• Strong matrix leadership skills with the ability to influence without formal authority.
• Highly organized with exceptional project management capabilities.
• Agile, proactive, and solutions-oriented with a strong sense of ownership.
• Excellent communication and stakeholder management skills.
• Ability to operate effectively in a lean, fast-paced, and evolving environment.

Key Responsibilities

• Provide end-to-end operational leadership for assigned clinical trial(s), ensuring alignment with overall development strategy and company objectives.
• Lead the cross-functional Clinical Trial Team (CTT), including representatives from Medical, Regulatory, Biometrics and CMC.
• Develop and maintain integrated trial timelines from start-up and protocol finalization through CSR, proactively managing critical path activities.
• Serve as the primary operational interface with the CRO Project Lead, ensuring clear oversight of the trial, performance metrics, and escalation pathways.
• Actively participate in appropriate CRO vendor selection, contracting, and performance management to ensure high-quality and cost-effective execution.
• Drive study start-up activities including country and site selection, feasibility, regulatory submissions, and first-patient-in readiness.
• Write the protocol, co-ordinating SME input and drive the review and finalization process
• Ensure compliance with ICH-GCP, FDA and other applicable regulatory requirements, and internal SOPs.
• Identify, assess, and mitigate trial risks; maintain issue, action, and decision logs and escalatie appropriately.
• Collaborate with the Clinical Program Lead and Head of Clinical Operations to manage study budgets in partnership with Finance, ensuring financial discipline without compromising quality.
• Ensure and support inspection and audit readiness; oversee implementation of corrective and preventive actions (CAPAs) when required.
• Contribute to continuous improvement of clinical operations processes, systems, and digital solutions to enhance efficiency and scalability.

Key Characteristics

• Extremely pro-active and solutions oriented
• Calm, resilient, and effective under pressure
• Naturally takes ownership and follows through
• Enjoys building structure in fast-moving, evolving environments
• Thrives in a small, entrepreneurial team setting

Place of Work

Alveus is a global organization with R&D teams in both the United States and Denmark. To support effective collaboration across time zones and ensure close alignment with our core development hubs, we are primarily seeking candidates based in the US.