Senior Director, Late Oncology

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Define the strategic vision and long-term direction for Late Oncology Program Management and Early Phase Program Management.

• Participate in the Clinical Operations Leadership Team, contributing to governance, resource planning, and operational excellence.

• Lead the comprehensive execution of complex late-phase oncology clinical trials, ensuring they are completed on schedule, within scope, and on budget.

• Foster operational excellence, risk management, and proactive mitigation strategies across late oncology trials.

• Develop options analysis and data-driven decision-making frameworks to address trial execution challenges.

• Collaborate with Clinical Operations, GCDO, Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, Safety, and R&D leadership.

• Cultivate relationships with CROs, academic research networks, trial steering committees, and KOLs.

• Contribute to operational feasibility assessments and early execution planning during the study concept and protocol development phases.

• Create, review, and defend global clinical program budgets and integrated timelines for governance committees and R&D leadership.

• Oversee financial planning, trial forecasting, resource allocation, and cost optimization efforts.

• Directly manage, mentor, and develop Clinical Operations Directors and Associate Directors.

• Enhance functional capabilities and ensure Program Leads possess the necessary competencies, tools, and resources.

• Recruit, retain, and scale clinical operations talent effectively.

• Promote alignment within global teams and flexible resource allocation across different time zones and geographic regions.

• Ensure oncology trials comply with ICH GCP, regulatory standards, and internal SOPs.

• Lead audit and inspection readiness efforts and contribute to audits, inspections, and regulatory inquiries.

• Integrate decentralized clinical trials, patient-centric execution models, and pragmatic trial designs.

• Embrace digital solutions, automated workflows, and predictive AI analytics.

• Optimize operational workflows, modernize SOPs, and encourage agile working methodologies.

⛳️ Requirements

• Demonstrated, repeatable success in delivering complex clinical trials and multi-country clinical trial portfolios, particularly in late-stage Phase 2/3/4 oncology development.

• Experience collaborating directly with Clinical Development Leads on program strategy, study design, protocol feasibility, and execution planning.

• Proven ability to develop, present, and oversee multi-million dollar clinical trial budgets and intricate timelines.

• Significant leadership experience in a global study management or clinical operations organization within the pharmaceutical, biotech, or CRO industry.

• Established track record in strategic function leadership, organizational design, and setting departmental vision.

• Capability to manage intricate technical details while maintaining a strategic enterprise perspective.

• Collaborate with Clinical Development and medical experts to translate scientific concepts into operationally feasible study designs and execution plans.

• Financial and governance expertise, including the ability to construct, analyze, and present integrated program/study budgets and timelines.

• Ability to function effectively across a matrixed global environment with time zone flexibility.

• Excellent communication, negotiation, and stakeholder management skills.

• Advanced degree (Ph.D., Pharm.D., M.S., or equivalent) in a life sciences, clinical research, or healthcare-related field is preferred.

• A Bachelor’s degree with exceptional industry experience may also be considered.

• Extensive biopharmaceutical industry experience in clinical trial operations, with significant senior leadership responsibilities in global study management.

• Direct line management experience is required, with preference given to candidates who have led people managers.

• Compliance with ICH GCP guidelines, global regulatory standards, and internal SOPs is essential.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.