Clinical Operations Development Lead

Role overview

This senior-level clinical leadership position is centered on guiding the strategy, structure, and delivery of global clinical development programs across complex therapeutic areas. Based in the United States, the role supports a highly matrixed biotech setting and works closely with medical development, project management, regulatory, and clinical operations teams to keep programs moving efficiently from early development through registration and post-approval phases.

The role balances strategic planning with hands-on operational leadership. It carries responsibility for budgets, schedules, risk oversight, and cross-functional coordination, while ensuring that studies and broader development programs are conducted with scientific discipline, operational quality, and full compliance with global regulatory expectations.

Accountabilities

• Partner with Medical Development Leads to jointly guide Clinical Development Teams and keep the Clinical Development Plan aligned with the overall strategy and execution goals.
• Create, refine, and sustain clinical development strategies across indications, making sure they fit the Target Product Profile and asset-level direction.
• Direct trial planning and execution from end to end, including timelines, resourcing, budgeting, and risk controls in collaboration with project management and finance.
• Own the development and upkeep of the Clinical Development Plan and drive it through governance review while keeping it practical and strategically aligned.
• Coordinate work across clinical operations, medical, regulatory, biostatistics, and other functions so clinical programs are delivered in an integrated way.
• Spot potential program risks, assess their impact, escalate when needed, and lead resolution of operational or strategic issues.
• Oversee CRO and vendor selection, engagement, and performance to ensure quality delivery and compliance with expectations.
• Maintain inspection readiness and ensure adherence to ICH-GCP, internal SOPs, and all relevant global regulatory requirements.
• Guide clinical trial design, feasibility assessments, country and site selection, and protocol development alongside global partners.
• Contribute to governance forums, program dashboards, and executive updates covering progress, risks, and financial status.
• Where applicable, manage Clinical Trial Managers and Clinical Trial Associates, including recruitment, onboarding, performance reviews, and professional development.
• Support process improvement efforts and help embed best practices across clinical operations and development activities.

Requirements

• A bachelor’s degree or higher in life sciences, medicine, pharmacy, biomedical sciences, or a related discipline; a PhD is considered an advantage.
• At least 10 years of experience in clinical development and/or clinical operations within pharma or biotech, including leadership of global trials.
• Deep knowledge of clinical trial design, delivery, and management across multiple phases, including outsourced models and CRO oversight.
• Proven track record of building and executing clinical development strategies and integrated development plans.
• Strong working knowledge of ICH-GCP guidance, global regulatory expectations, and clinical development standards.
• Experience managing complex clinical programs with responsibility for budgets, timelines, resources, and risk frameworks.
• Well-developed leadership, stakeholder management, and cross-functional collaboration skills in a global matrix environment.
• Excellent communication ability with a strong capacity to influence and align senior stakeholders across functions.
• Strong analytical and organizational skills, with the ability to juggle competing priorities and large-scale programs.
• Prior exposure to rare disease or autoimmune clinical development is an added advantage.
• Willingness to work globally with occasional travel as required.

Benefits

• Base pay range of $212,000 to $291,500, plus eligibility for short-term and long-term incentive plans.
• Health, dental, vision, life, and disability insurance coverage.
• Retirement savings plan with employer matching.
• Paid time off along with additional well-being support programs.
• Performance-linked incentive opportunities tied to personal and business results.
• Exposure to global clinical development strategy spanning multiple indications and therapeutic areas.
• A high-visibility leadership position with senior governance and executive exposure.
• The opportunity to help shape innovative clinical development programs in a fast-growing biotech environment.

Additional information

This opportunity is listed on behalf of a partner organization, which handles all applications and the next steps in the hiring process. The partner company is the employer and will manage review, interviews, and any assessments.

Privacy and hiring process notice

Applications are reviewed through an AI-assisted matching process designed to help identify candidates who best fit the role’s core requirements. Shortlisted applications are shared with the hiring employer, while final hiring decisions and next steps are handled by their internal team.

By applying, candidates acknowledge that personal data may be processed to evaluate candidacy and share relevant information with the hiring employer, based on legitimate interest and pre-contractual measures under applicable data protection laws, including GDPR. Applicants may exercise applicable rights such as access, rectification, erasure, and objection.

Artificial intelligence tools may be used to support parts of the hiring workflow, including application review, resume analysis, and detection of inconsistencies or verification signals. These tools assist recruiters but do not replace human judgment, and final hiring decisions are made by people.