Clinical Operations Lead

This is what you will do

An experienced Clinical Operations Lead with a strong background in global drug development, capable of providing strategic and operational leadership across complex clinical development programs. The Clinical Operations Lead (COL) ensures the integration and continuity of Clinical Operations activities across Early Phase, Late Phase and Real‑World Evidence (RWE) studies, acting as the operational representative within the Clinical Development Plan (CDP) team and as functional leader of Clinical Project Managers (CPMs).

You will be responsible for

Program Leadership & Strategy

• Ensure alignment and integration of all studies within the program
• Contribute to the Clinical Development Plan (feasibility, timelines, geographic strategy, budget)
• Maintain overall operational oversight, integrated timelines, and key milestones (incl. go/no‑go)
• Act as primary Clinical Operations interface for cross‑functional teams

Clinical Operations Oversight

• Oversee end‑to‑end Clinical Operations activities
• Support CPMs on operational decisions and compliance (ICH‑GCP, SOPs)
• Contribute to study design, CPAC preparation, and feasibility
• Ensure consistency across studies within the program
• Define and oversee vendor/CRO strategies
• Support RFPs, evaluations, and Bid Defense Meetings
• Manage escalations and vendor governance

Budget Oversight

• Support planning, forecasting, and variance analysis
• Align with CPMs and Finance

Governance & Stakeholder Management

• Participate in governance bodies (CPRF, PRM, XRC)
• Present program updates and risks
• Facilitate cross‑functional alignment and decision‑making

Functional Leadership of CPMs

• Provide functional supervision and escalation support
• Coach and support development (feedback, IDPs, objectives)
• Drive risk mitigation, CAPAs, and inspection readiness
• Promote quality and proactive risk management

Clinical Documentation & Regulatory Support

• Support regulatory documentation (eCTD, CSR/CIR)
• Contribute to registry submissions and results communication

Process Excellence

• Support SOPs and continuous improvement initiatives
• Ensure compliance with required training

You will need to have

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.
• Significant experience in Clinical Operations within the pharmaceutical/biotechnology industry or CRO.
• Proven experience managing global clinical development programs across Early Phase, Late Phase, and Real‑World Evidence (RWE) studies.
• Strong understanding of clinical drug development processes and Clinical Development Plans (CDPs).
• Demonstrated ability to oversee multiple clinical studies within a complex development program.
• Experience coordinating cross‑functional teams and acting as a key interface between Clinical Operations and other development functions.
• Solid knowledge of ICH‑GCP guidelines, applicable regulatory requirements, and clinical research best practices.
• Experience in Clinical Research Organization (CRO) selection, oversight, and vendor management.
• Strong project and program management skills, including timeline development, milestone tracking, risk management, and budget oversight.
• Experience managing complex integrated project plans and clinical development timelines.
• Proven ability to provide strategic and operational guidance during protocol development and study planning.
• Experience preparing clinical documentation supporting regulatory submissions (e.g., eCTD components).
• Previous experience with functional leadership, mentoring, or matrix management of Clinical Project Managers or equivalent roles.
• Strong stakeholder management skills, with experience interacting with senior leadership and governance committees.
• Excellent communication, influencing, and presentation skills.
• Strong analytical and problem‑solving capabilities with the ability to make decisions in a complex environment.
• Ability to work effectively in a global, matrixed, and multidisciplinary organization.
• Fluency in English, both written and spoken.

We would prefer for you to have

• Experience in Neonatology, Rare Diseases, Respiratory or Specialty Care therapeutic areas.
• Experience supporting global regulatory submissions.
• Previous participation in governance bodies and por