About this role
Accountabilities
- Develop clinical operational strategies and oversee global clinical study teams, CROs, and vendors to ensure studies are delivered on time, within budget, and in accordance with SOPs and ICH/GCP requirements.
- Lead operational execution across the full clinical trial lifecycle, including feasibility, planning, study start-up, conduct, close-out, and reporting.
- Identify program-level operational risks, develop mitigation strategies, and proactively escalate significant issues to the appropriate internal stakeholders.
- Contribute to clinical development plans and clinical protocol design by providing operational expertise and practical recommendations.
- Lead cross-functional study execution teams and coordinate stakeholders toward study goals, milestones, and deliverables.
- Provide oversight and quality control of CRO and vendor activities, monitoring scope, performance metrics, compliance, and inspection readiness.
- Support CRO and vendor governance meetings, contributing to governance frameworks, performance reviews, risk escalation, and improvement plans.
- Drive continuous process improvement and adoption of operational best practices across clinical programs.
- Ensure global inspection readiness and support or lead interactions during regulatory inspections.
- Manage financial and resource considerations across clinical operations, helping ensure efficient allocation and delivery.
- Leverage AI-enabled tools to improve individual productivity, work quality, and operational efficiency.
- Perform additional clinical operations responsibilities as required and travel up to 20% when needed.
Requirements
- Bachelor’s degree in a scientific, healthcare, or related discipline preferred.
- 6–8+ years of relevant clinical operations experience within the pharmaceutical or biotechnology industry.
- At least 3 years of experience supporting oncology clinical trials.
- Previous people-management or clinical leadership experience is preferred.
- Experience with radiopharmaceuticals, theranostics, and/or companion diagnostic development programs is highly desirable.
- Deep understanding of global clinical trial operations, ICH-GCP requirements, and applicable regulatory expectations.
- Demonstrated ability to lead complex clinical programs and cross-functional teams while driving effective decision-making.
- Strong project management, financial management, resource planning, and vendor oversight capabilities.
- Excellent communication skills, with the ability to proactively engage stakeholders, identify challenges, and drive timely resolution.
- Highly organized, detail-oriented, action-focused, and committed to quality and consistency.
- Ability to operate independently and adapt effectively within a dynamic environment with changing priorities.
- Proficiency with Microsoft Project and SmartSheet is desirable.
- Willingness and ability to use emerging technology and AI tools to enhance clinical operations workflows.
Benefits
- Remote position based in the United States.
- Base salary range of $173,217–$209,899 , with final compensation determined by factors including location, skills, experience, and role requirements.
- Potential eligibility for additional discretionary incentive compensation and stock opportunities.
- Comprehensive benefits covering medical, dental, vision, life, and disability insurance, subject to applicable plan terms.
- Wellbeing support and retirement and financial protection programs.
- Flexible Time Off for eligible U.S.-based exempt employees, with no fixed accrual limit subject to manager approval.
- 11 paid company holidays annually for eligible employees.
- Additional paid time-off programs may include sick leave, volunteer days, summer-hours flexibility, and various family, medical, caregiver, bereavement, and military leaves.
- Annual global shutdown between Christmas Day and New Year’s Day for eligible employees.
- Commitment to workplace accommodations and support for employees with disabilities.
- Mission-driven environment focused on advancing innovative therapies for patients with serious diseases.
- Collaborative, multidisciplinary culture with opportunities to contribute to meaningful clinical development programs.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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