Global Study Lead – Managed Access Program Experience

This is a fully remote position, open to applicants in Bulgaria, +4 more states.

📋 Description

• Provide strategic leadership and overall accountability for the operational planning and execution of assigned studies/programmes from initiation through to completion and archiving.

• Lead and supervise Managed Access Programs across the UK and/or EMEA.

• Offer leadership and oversight for PACT and/or PTA programmes where relevant.

• Serve as a vital member of the Study Leadership Team, representing Clinical Operations in strategic study discussions and decision-making.

• Own the operational vision and strategy for the successful delivery of studies.

• Direct global, cross-functional, and matrix study teams to fulfill programme objectives.

• Ensure that studies/programmes adhere to agreed timelines, quality standards, and budget expectations.

• Provide oversight and assistance to study management colleagues responsible for daily operational execution.

• Act as the primary escalation point for Clinical Operations concerning assigned programmes.

• Develop operational plans and ensure adequate feasibility and upfront planning.

• Identify, evaluate, and mitigate operational risks and issues.

• Communicate the status, expectations, risks, issues, and key decisions of studies/programmes to both internal and external stakeholders.

• Offer strategic oversight for operational contributions to protocols, informed consent documents, and other critical paperwork.

• Maintain oversight of programme quality, compliance, and readiness for inspection.

• Ensure adherence to ICH-GCP, regulatory standards, SOPs, and company policies.

• Provide strategic oversight of CROs, FSP providers, and third-party vendors.

• Assist in vendor assessment and selection, ensuring ongoing governance and oversight of vendors.

• Maintain accountability for study/programme budgets and participate in governance and financial review cycles.

• Cultivate relationships with senior stakeholders and influence decision-making within complex matrix organizations.

• Promote continuous improvement and discover innovative methods for operational delivery.

• Contribute therapeutic-area and operational expertise to the oncology portfolio delivery.

⛳️ Requirements

• Extensive clinical research and clinical development experience within a pharmaceutical, biotechnology, or CRO environment.

• Demonstrated experience as a Global Study Lead, Global Trial Lead, Senior Clinical Trial Manager, Senior Global Study Manager, or an equivalent position.

• Previous experience in leading or providing significant operational leadership/oversight of Managed Access Programs within the UK and/or EMEA is highly preferred.

• Extensive experience in leading complex global studies or programmes with accountability for operational execution.

• Ability to lead high-performing, geographically dispersed, and cross-functional matrix teams.

• Strong comprehension of global clinical development, clinical operations, and regulatory processes.

• Proficient in managing study/programme timelines, budgets, risks, and quality.

• Robust experience in CRO/vendor oversight, including performance or quality issue management and escalation.

• Thorough knowledge of ICH-GCP and pertinent global regulatory requirements.

• Capability to operate independently and make complex decisions in fast-paced environments.

• Strong stakeholder management skills with the ability to influence senior stakeholders.

• Excellent leadership, communication, negotiation, and conflict-resolution abilities.

• Strong project and programme management skills.

• MAP leadership experience within the UK and/or EMEA is highly desirable.

• PACT experience is highly desirable.

• PTA programme experience is highly desirable.

• Experience with oncology studies or programmes is advantageous.

• Experience in a global pharmaceutical FSP or embedded delivery model is desirable.

• Experience in leading complex, innovative, or non-traditional clinical programme models is desirable.

• Experience working with investigators, external experts, regulatory authorities, CROs, and third-party vendors is desirable.

• Bachelor's degree in Life Sciences, Health Sciences, or a related scientific discipline, or equivalent relevant experience.

🏝️ Benefits

• Reasonable accommodations to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment.

• Equal Opportunity Employer.