Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI)

POSITION SUMMARY

The Senior Clinical Trial Manager (Sr. CTM) is responsible for the planning, execution, and oversight of global clinical trials to ensure they are delivered on time, within budget, and in compliance with applicable regulatory requirements, Good Clinical Practice (GCP), and company SOPs. This role provides operational leadership to cross-functional study teams, vendors, and clinical research sites, and plays a critical role in advancing the company’s clinical development programs.

QUALIFICATIONS

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
• 7+ years of clinical operations experience in the biopharmaceutical industry, including at least 3 years in clinical trial management.
• Proven track record of independently managing global clinical studies from start-up to completion.
• Strong knowledge of ICH-GCP guidelines, FDA/EMA regulations, and overall drug development process.
• Experience managing CROs, vendors, and investigator sites.
• Excellent project management, organizational, and problem-solving skills.
• Strong interpersonal, leadership, and communication skills with the ability to work in a fast-paced, team-oriented environment.
• Proficiency with clinical trial management systems (CTMS), electronic data capture (EDC), and Microsoft Office Suite.

PREFERRED EXPERIENCE

• Experience in rare disease, oncology, or other specialty therapeutic areas.
• Prior experience in a small to mid-size biopharmaceutical company with a hands-on, flexible, and proactive approach.
• Global clinical trial management experience.
  Rezolute (RZLT) currently anticipates the base salary for the Sr. Clinical Trial Manager role could range from $145,000 to $185,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
  Qualifying employees are eligible to participate in benefit programs such as:
  Health Insurance (Medical / Dental / Vision)
  Disability, Life & Long-Term Care Insurance
  Holiday Pay
  Tracking Free Vacation Program
  401(k) Plan Match
  Educational Assistance Benefit
  Fitness Center Reimbursement
  We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class

• Lead the operational planning, execution, and management of Phase I–IV clinical trials, including study start-up, conduct, and close-out activities.
• Serve as the primary point of contact for internal teams, clinical sites, CROs, and other external vendors.
• Oversee site selection, feasibility assessments, and initiation to ensure successful patient recruitment and retention.
• Manage timelines, budgets, and study milestones; proactively identify and mitigate risks.
• Develop and maintain study-related documents, including protocols, informed consent forms, monitoring plans, and trial management tools.
• Ensure adherence to ICH-GCP, regulatory guidelines, and company SOPs throughout study execution.
• Collaborate with cross-functional teams (Regulatory Affairs, Clinical Development, Biostatistics, Data Management, Pharmacovigilance, Quality Assurance, etc.) to ensure alignment and study success.
• Oversee vendor and CRO performance, including contract management, deliverables, and quality of work.
• Provide mentoring and guidance to Clinical Trial Managers, Associates, or other junior team members.
• Contribute to continuous improvement of clinical operations processes and best practices.