Global Study Lead

Key Responsibilities

• Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables.
• Drive assessment, selection, engagement, management, and oversight of appropriate vendors.
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and sponsor SOPs, for all products and services delivered for their designated studies.
• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
• Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project allocation
• Preparation of materials for governance and / or financial review cycles and provide expert clinical operational input into protocol development.
• Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary.
• Identify and communicate resource gaps for assigned studies.
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
• Lead / contribute to ways of working and process improvement initiatives. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
• Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study and collaborate with aligned staff in global functions to deliver the Clinical Study Report.
• Work with the patient councils to develop patient centric documents and address patient burden.

Qualifications

• Bachelor's degree in life sciences or related discipline.
• Extensive clinical development experience that is equivalent to 5+ years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
• Proven operational experience leading global clinical trials and knowledge of essential global regulatory guidelines and ICH/GCP.
• Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
• Proven leadership skills, influencing and negotiation skills.
• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

Preferred Qualifications

• Oncology phase III global registrational study leadership experience.
• Proven clinical development experience across all phases of development (I-IV).
• Experience of innovative trial design (platform, basket, umbrella, adaptive designs) and decentralized trials (DCT) initiatives.
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict.
• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Creative thinker able to modernize approach to clinical delivery, leverage externally.