This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Operations Development Lead based in United States.
This senior clinical leadership role is responsible for driving the strategy, design, and execution of global clinical development programs across complex therapeutic areas. The position plays a pivotal role in co-leading clinical development teams, shaping integrated clinical development plans, and ensuring alignment from early development through registration and post-approval activities. Working in a highly matrixed, global biotech environment, the role partners closely with medical development, project management, regulatory, and clinical operations functions to ensure seamless execution of clinical strategies. It requires a strong balance of strategic oversight and operational depth, including responsibility for budgets, timelines, risk management, and cross-functional alignment. The Clinical Operations Development Lead ensures that clinical programs are executed with scientific rigor, operational excellence, and compliance with global regulatory standards. This is a high-impact role that directly influences clinical development success and portfolio progression across multiple indications.
Accountabilities:
- Co-lead Clinical Development Teams (CDTs) with Medical Development Leads, ensuring alignment on clinical development strategy and execution of the Clinical Development Plan (CDP).
- Define, develop, and maintain clinical development strategies across indications, ensuring consistency with the Target Product Profile and overall asset strategy.
- Oversee end-to-end clinical trial planning and execution, including timelines, budgets, resources, and risk mitigation in collaboration with project management and finance teams.
- Drive creation and maintenance of the CDP, ensuring endorsement by governance bodies and alignment with strategic objectives and operational feasibility.
- Lead cross-functional coordination across clinical operations, medical, regulatory, biostatistics, and other stakeholders to ensure integrated execution of clinical programs.
- Identify, assess, and mitigate program risks, ensuring escalation when needed and driving resolution of complex operational or strategic issues.
- Oversee vendor and CRO selection and management, ensuring operational quality, compliance, and delivery against expectations.
- Ensure inspection readiness and compliance with ICH-GCP, SOPs, and applicable global regulatory requirements across all clinical activities.
- Provide oversight of clinical trial design, feasibility, country/site selection, and protocol development in collaboration with global stakeholders.
- Contribute to governance meetings, program dashboards, and executive reporting on progress, risks, and financial performance.
- May provide line management for Clinical Trial Managers and Clinical Trial Associates, including hiring, onboarding, performance management, and development.
- Support continuous improvement initiatives and promote best practices across clinical operations and development functions.
Requirements:
- Bachelor’s or advanced degree in life sciences, medicine, pharmacy, biomedical sciences, or related field; PhD is a plus.
- 10+ years of experience in clinical development and/or clinical operations within the pharmaceutical or biotechnology industry, including global trial leadership responsibilities.
- Strong expertise in clinical trial design, execution, and management across multiple phases, including outsourced models and CRO oversight.
- Demonstrated experience in developing and executing clinical development strategies and integrated development plans.
- Strong understanding of ICH-GCP guidelines, global regulatory requirements, and clinical development best practices.
- Proven ability to manage complex clinical programs, including budgets, timelines, resources, and risk frameworks.
- Strong leadership, stakeholder management, and cross-functional collaboration skills in a global matrix environment.
- Excellent communication skills, with the ability to influence, align, and engage senior stakeholders across functions.
- Strong organizational and analytical skills with the ability to manage competing priorities and complex programs.
- Experience in rare disease or autoimmune clinical development is a plus.
- Willingness to operate in a global environment with periodic travel as required.
Benefits:
- Competitive base salary range of $212,000 – $291,500, plus eligibility for short-term and long-term incentive programs.
- Comprehensive health, dental, vision, life, and disability insurance coverage.
- Retirement savings plan with employer matching contributions.
- Generous paid time off and additional well-being support programs.
- Performance-based incentive opportunities aligned with individual and company success.
- Exposure to global clinical development strategy across multiple indications and therapeutic areas.
- High-impact leadership role with visibility at senior governance and executive levels.
- Opportunity to shape innovative clinical development programs in a fast-growing biotech environment.