Clinical Trial Execution Expert/CTL - Onco

About Innovation Unit China

Innovation Unit China (China R&D Center) is a strategic innovation hub within Boehringer Ingelheim’s global R&D network, established to harness China’s rapidly evolving scientific capabilities and vibrant innovation ecosystem. By integrating Experimental Medicine, External Innovation, Development CMC, and Clinical Pharmacology & Non-clinical Safety Science, IU China connects promising science with early development expertise to accelerate high-potential opportunities, contribute to the global pipeline, and help accelerate breakthrough therapies for patients in China and around the world.

Responsibilities

As a Clinical Trial Execution Expert (CTEE), Will be responsible and accountable for leading the operational execution of designated trials, translating asset and program strategies into robust execution plans, and ensuring seamless delivery across all phases of study conduct. As a member of the Innovation team, will also contribute to operational strategy development while primarily focusing on trial execution with excellence, proactive risk management, and accelerating trial delivery in support of innovative TA programs
- Ensure effective, efficient and high-quality operational set-up, planning, execution, evaluation and reporting of clinical trials up to Proof of Concept (PoC), meeting regulations, timelines and budgets.

- Apply strategic and scientific understanding of assets and consider competitor programs, their operational execution, data, and development milestones to lead and execute innovative clinical development programs that prioritize success.

Lead the early clinical trial execution, supported by cross-functional team members, contributing to clinical trial design, planning, preparation, conducting and reporting of clinical trials from first in human use to the PoC milestone of Boehringer Ingelheim’s new development pipeline compounds as well as Clinical Pharmacology studies.

- Manage the planning, implementation, and tracking of the clinical trial process as well as risk mitigation and proactive communication of trial status to stakeholders, escalating issues as appropriate.

Lead the development and execution of the vendor plan for the trialand related interactions with CROs as well as oversee vendor services specific to the asset and study.

Support the development and execution of external stakeholder engagement and operational site network strategy for the assigned asset with a focus on clinical trial execution excellence to advance the asset strategy.

Qualifications
• University degree (Master´s degree or comparable degree; PhD preferred) in life sciences or a related field with longstanding (10+ years) pharmaceutical industry experience in TA with majority in (first-in-human, phase 1 and proof of concept studies).

• Experience overseeing CROs, vendors, and external partners, including performance and risk management.

• Demonstrated track record of delivering complex early-stage Phase1/2 clinical trials against timelines, budget, quality, and recruitment objectives.

• Experience in protocol operationalization, feasibility assessment, and study execution planning.

• Strong understanding of oncology trial endpoints, biomarker strategies, and adaptive trial designs.

• Global study leadership experience working in a multi-cultural environment and in-depth understanding of corporate culture and cross-culture dynamics.

• In-depth knowledge of early clinical development in line with GCP and other applicable regulations.

• Strong leadership and team management skills with the ability to translate complex situations into actionable items.

• Ability to inspire and motivate cross-functional teams toward shared goals

• Fluency in English.