Clinical Study Delivery Lead, Global Clinical Operations, Oncology

Orion

Lead global oncology clinical trials focusing on planning, execution, and oversight at Orion Corporation. Ensuring quality data and compliance within budget and timelines while collaborating with cross-functional teams.

Posted 7/10/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $140,000 - $230,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide global leadership for the planning, set up, execution, oversight, and delivery of complex oncology clinical trials from First in Human (FIH) through late phase Ph2/3 registration studies and submission.
Lead the end to end execution of global Phase I–III oncology studies, including FIH and registration enabling trials, from startup through closeout, to ensure the study is delivered within timelines, budget and with high quality.
Provide hands-on project leadership in a global, cross-functional setting, including study timelines projection, protocol development support, site selection/activation, vendor management, timeline/budget oversight, risk/issue resolution, and CRO performance management.
Plan, drive and oversee study start up, site activation, enrollment strategy, patient retention, data quality oversight, database readiness, study reporting and CSR delivery aligned with regulatory strategy submission plans.
Ensure rigorous vendor oversight, particularly CRO performance (monitoring, data management, labs, imaging, ePRO, etc.).
Proactively identify operational risks and implement robust mitigation plans. Escalate critical issues and propose solutions to senior leadership.
Plan and manage study timelines, project site activation, recruitment and readout timelines, including building various scenarios depending on data-driven study outcome assumptions and other requirements.
Manage clinical trial budgets, forecasting, accruals, and change orders.
Ensure adherence to ICH GCP, local/global regulations, SOPs, and audit readiness, including respond to audits/inspections, and coordinate CAPA implementation, as needed.
Partner closely with internal and external stakeholders to deliver integrated milestones.
Chair global study team meetings, drive team collaboration and ensure clear decision making and documentation.
Build strong relationships with investigators, global KOLs, and academic partners as required.

Requirements

What you’ll need

Master's degree in a scientific discipline preferred (advanced degree favored); equivalent extensive experience considered (e.g., from nursing/monitoring background progressing to PM).
10+ years of clinical operations experience, with 5+ years leading global oncology studies.
Proven leadership of early phase oncology trials, including FIH, dose escalation/expansion, safety monitoring, and DMC interactions.
Experience with late phase, global registration directed trials, including operational planning for NDA/BLA/MAA submissions.
Experience in immuno oncology, biologics and targeted therapies in solid tumor indications.
Demonstrated ability to manage global CROs, complex budgets, and multi vendor landscapes.
Strong understanding of oncology drug development, adaptive design, biomarkers, imaging, safety reporting, and protocol complexities.
Expertise in ICH GCP, global regulatory requirements, and inspection readiness.
Strong team player, and team-driver mindset with excellent communication, negotiation, conflict resolution, and stakeholder management skills.
Hands-on, pragmatic, solution-oriented approach, analytical skills, and ability to anticipate/resolve issues proactively.
Ability to travel internationally as needed.

Benefits

Comp & perks

Continuous learning investment
Competitive salary
Work on challenges that matter
Focus on teamwork and low hierarchies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Oncology Drug DevelopmentClinical Operations ManagementProtocol DevelopmentData Quality OversightRisk Mitigation PlanningCRO Performance ManagementPatient Retention StrategiesStudy ReportingNDA/BLA/MAA Submission PlanningImmuno Oncology Experience

Soft Skills

Excellent CommunicationNegotiation SkillsConflict ResolutionStakeholder ManagementTeam Collaboration