Senior Director, Early Oncology

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

📋 Description

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

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

• Cultivate a high-performance and inclusive culture throughout the organization.

• Ensure the successful end-to-end execution of complex global early-phase Phase 1 and 1b oncology clinical trials according to schedule, scope, and budget.

• Champion operational excellence, risk management, and proactive mitigation strategies across early-phase trials.

• Develop options analysis and frameworks for data-driven decision-making.

• Collaborate with Clinical Operations, GCDO, Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, Safety, R&D leadership, CROs, academic research networks, steering committees, and KOLs.

• Contribute to operational feasibility assessments and execution planning during the development of study concepts and protocols.

• Formulate, 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.

• Establish vendor strategy, performance metrics, and governance structures in collaboration with Strategic Outsourcing and Clinical Innovation.

• Engage in executive vendor reviews, steering committees, and escalation of contract issues.

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

• Enhance functional capabilities and equip Program Leads with the necessary competencies, tools, and resources.

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

• Facilitate global alignment and flexible resourcing across various time zones and regions.

• Ensure oncology trials adhere to ICH GCP, global regulatory standards, and Jazz SOPs.

• Drive audit and inspection readiness, supporting audits, inspections, and regulatory inquiries.

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

• Lead the adoption of digital solutions, automated workflows, and predictive AI analytics.

• Optimize workflows, modernize SOPs, and champion agile working methods.

⛳️ Requirements

• Proven track record in delivering complex clinical trials and multi-country portfolios, particularly in early-phase (Phase 1) oncology.

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

• Proficient in developing, presenting, and overseeing multi-million-dollar clinical trial budgets and intricate timelines.

• Extensive leadership experience in global study management or clinical operations within the pharmaceutical, biotech, or CRO industries.

• Demonstrated capability in strategic functional leadership, organizational design, and departmental vision formulation.

• Ability to manage complex technical details while maintaining a strategic enterprise-wide perspective.

• Experience partnering with Clinical Development and medical experts to convert scientific concepts into operationally feasible study designs and execution plans.

• Expertise in constructing, analyzing, and presenting integrated program/study budgets and timelines.

• Capacity to operate effectively across a matrixed global environment while accommodating time zone flexibility.

• Exceptional communication, negotiation, and stakeholder management abilities.

• 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 combined with outstanding industry experience will also be considered.

• Significant experience in the biopharmaceutical industry, particularly in clinical trial operations, with considerable senior leadership responsibility in global study management.

• Direct line management experience required, with a preference for leadership of people managers.

• For candidates based in the US, compliance with applicable US work eligibility requirements is necessary as indicated by the US-based compensation section.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.