End-to-End Clinical Trial Lead – Biotech

Alveus Therapeutics group; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Alveus Therapeutics is seeking a US-based Clinical Trial Lead to oversee end-to-end operational delivery of US trials, from start-up through CSR completion. You will lead the cross-functional Clinical Trial Team and serve as the primary operational counterpart to the CRO, ensuring timely, within-budget execution in a lean biotech environment.

Ideal candidates bring 10+ years in biotech or CRO clinical operations, strong matrix leadership, and excellent communication and stakeholder management in

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree 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 CRO oversight and vendor management experience.
• Experience in small or emerging biotech companies strongly preferred.
• Deep knowledge of clinical trial execution and regulatory requirements (ICH-GCP, FDA).
• Strong matrix leadership skills with ability to influence without formal authority.
• Highly organized with exceptional project management capabilities.
• Agile, proactive, and solutions-oriented with ownership.
• Excellent communication and stakeholder management skills.
• Ability to operate effectively in a lean, fast-paced, evolving environment.

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.

Skills

Matrix leadership

Stakeholder management

Communication skills

Ownership

Agile mindset

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Alveus Therapeutics is seeking a US-based Clinical Trial Lead to oversee end-to-end operational delivery of US trials, from start-up through CSR completion. You will lead the cross-functional Clinical Trial Team and serve as the primary operational counterpart to the CRO, ensuring timely, within-budget execution in a lean biotech environment.

Ideal candidates bring 10+ years in biotech or CRO clinical operations, strong matrix leadership, and excellent communication and stakeholder management in