Are you passionate about Clinical Trials and energized by the end-to-end operational delivery of clinical trials in a small but fast growing biotech?
Alveus Therapeutics is seeking a 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 clinical trials, from study start-up through database lock and Clinical Study Report (CSR) completion. The CTL leads cross-functional trial teams 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. You will report into our Head of Clinical Operations.
The salary range for this position is $160,000 – $ 210,000 per year + benefits.
Actual compensation will be determined based on experience, skills, internal equity, and location.
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
Key Competencies
- 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 trials, 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, coordinating 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 escalate 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 alignment with our core development hubs, this remote full-time role is based on the U.S. East Coast. Once the new Alveus office is established, occasional in‑person attendance may be required, typically a few days per month.
