Head of Clinical Operations, ExpMED China (Shanghai, China, Shanghai)

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.

Head of ClinOps(Double Hatted CTM Country Lead),China

The purpose of the position :

1)To steer Clinical Operations pre-poc with the target to optimally address speed, quality and efficiency of preparation, conduct, analyzing and reporting of Clinical Trials and Development Programs within the definitions set by legal and regulatory boundaries as well as scientific and ethical standards.

2)Provides strategic leadership and operational oversight at the Regional/Operative Unit (R/OPU) level to ensure the successful planning, execution, and reporting of high-quality pre-PoC clinical trials in alignment with corporate and functional objectives. This role is pivotal in building and managing a high-performing team of Clinical Trial Managers (CTMs) or Regional CTMs (RCTMs), fostering a culture of excellence and accountability, grounded in science.

3) Serves a the regional liaison for assigned countries and regions, ensuring oversight of clinical trial delivery and acting as the primary point-of-contact for Clinical Operations topics. Collaborates with global teams to share best practices, resolve challenges, and lead or participate in strategic initiatives.

Key responsibilities include:

*   Overseeing trial delivery and CTM performance, ensuring adherence to timelines, budgets, recruitment goals, and regulatory, legal, ethical, and quality standards while safeguarding patient safety and data integrity.

*   Serving as the primary point of contact for clinical operations topics within assigned countries/regions and liaising with internal stakeholders such as Clinical Development Operations, Medical Affairs, and Quality Medicine.

*   Managing resource allocation, personnel development, and performance management, including compliance with SOPs, process documents, and training curricula.

*   Supporting the Global Head of Clinical Trial Management with budget oversight, strategic initiatives, and issue resolution.

*   Driving process optimization, operational excellence, and cross-functional collaboration to meet pipeline commitments and enhance study management capabilities.

* Serving as the liaison for assigned countries to coordinate clinical trial resourcing and delivery.

* Where required, act as administrative line manager to ExpMED personnel within country.

The Team Lead ensures consistent communication with stakeholders, provides trial updates, and escalates operational issues as needed. This role is critical in promoting efficiency, quality, and patient-centricity across all R/OPU pre-PoC clinical trial activities.

1. Team Leadership and Delivery of Pipeline Commitments

Provide strategic leadership and operational oversight at the R/OPU level to ensure excellence in planning, design, quality, and execution of pre-PoC clinical trials, delivering the R/OPU contribution and meeting pipeline commitments aligned with ExpMED priorities. Ensure R/CTMs understand their accountabilities, responsibilities, and deliverables, including optimal planning, resourcing, and trial execution.

Oversee trial management from start-up to closure, ensuring quality, timelines, recruitment, cost control, and resource utilization. Lead strategy for inspection readiness and sponsor oversight, and support CTMs in timely resolution of trial-related issues, including monitoring oversight and open deviations.

Promote best practices by leveraging data, technology, and patient-centric approaches to maximize value for sites and participants. Critically evaluate data for accuracy and completeness in key deliverables (e.g., trial reviews, budgets) and make objective, data-driven decisions.

Act as a role model by integrating Our Behaviors into daily leadership, fostering a high-performing team culture, and proposing solutions to operational challenges with clear risk analysis.

2. Talent Management and Workforce Development

Build and sustain a high-performing Clinical Ops workforce through effective recruitment, onboarding, development, and retention strategies in close collaboration with the Global

Provide strong team leadership by setting clear expectations, fostering accountability, and creating an empowering environment that motivates colleagues and promotes a cohesive Experimental Medicine identity.

Lead performance management activities, including MAG reviews, development planning, and timely feedback, while identifying performance challenges and implementing action plans.

Cultivate a performance-driven culture with a sense of urgency for achieving results, ensuring staff are coached and developed in department-specific knowledge, processes, and procedures.

3. Compliance and Quality Assurance:

· Ensure adherence to national and international regulatory and legal requirements, as well as internal SOPs and guidelines.

· Cross functional cooperation within and across

departments for:

* Audits (internal and external)

• Inspections (Sponsor/ site)

* Support the CAPA process and timely issue resolution. · Provide leadership and guidance to ensure R/CTM oversight of clinical trial activities is enhanced.

* Provide proactive solutions to issues arising in clinical trials.

4. Cross-Functional Collaboration

Develop and maintain strong relationships with internal and external stakeholders to ensure effective cross-functional collaboration and alignment at local, regional, and global levels. Internal stakeholders include R/OPU Medical Affairs, Planning Hub, Clinical Development Operations functions, and Quality Medicine. External stakeholders may include investigators and patient advocacy organizations.

Represent ExpMED Clinical Operations in interdisciplinary projects, working groups, and joint initiatives to enhance clinical trial strategies, integrate trial management topics, and support business objectives.

Actively contribute to stakeholder alignment and participate in relevant congresses to foster collaboration and knowledge sharing across ExpMED.

5. Strategic Collaboration and Operational Planning

Actively participate in global and local therapeutic area (TA) meetings, Clinical Operations trial reviews, and other strategic discussions as the Clinical Operations representative on relevant project teams.

Provide operational feedback on proposed study designs and endpoints, and facilitate input from country experts to optimize trial feasibility and execution.

Support global TA teams in identifying innovations and synergies to enhance clinical development programs, while assisting country/region teams with the implementation of new systems and processes.

Proactively plan and prepare for the successful conduct of trials of strategic importance to the company and/or region, ensuring alignment with organizational priorities.

6. Resource Management and Allocation

Coordinate and manage resources across therapeutic areas and the R/OPU portfolio to ensure optimal trial delivery. Oversee CTM resourcing, capacity planning, and trial allocation in collaboration with the global ExpMed Clinical Operations team. Manage recruitment and onboarding of qualified R/OPU CTMs and external CRO RCTMs as applicable to maintain appropriate resource levels, expertise, and team dynamics.

Support the Global Head, CTM in resource planning and allocation across the entire portfolio to achieve operational efficiency and meet pipeline commitments.

7. Regional Liaison and Coordination

Liaison for assigned countries conducting ExpMED clinical trials.

Ensure resourcing and coordinate oversight of trial delivery within assigned regions and primary point-of-contact for Clinical Operations topics of relevance across the region.

Collaboration with global teams to share best practices, resolve challenges, lead / participate in initiatives.

8. Support the Global Head, Clinical Trial Management, in implementing a customer-focused culture within ExpMED by promoting a commitment to customer-centric behaviors:

* provides visibility to trial teams and broader Clinical Operations into ongoing work through tracking of clinical trial performance

* maintains high degree of responsiveness to

both internal and external requests

* resolve issues by working collaboratively across Clinical Operations and other groups within the broader organization and serving as a single point of

escalation.

* Drive ownership and empowerment of study teams.

9.1. Leadership of Vendor/Contract/IMP/Monitoring/System&Support Management in ExpMed China:

- Oversight of vendors in clinical operations to ensure they meet Boehringer Ingelheim expectations, including participation in vendor selection, setting and monitoring vendor performance and organization of governance meeting

- Oversight of contract, site engagement in clinical operations to ensure trial delivery

- Oversight of system and support team in clinical operations to ensure support process to clinical trial project

- Provide strong support for all locally outsourced CRO managed trials in the achievement of trial deliverables on time, on budget and with high quality

Required Capabilities

University degree in Life Sciences, Biomedical Sciences, Health Sciences, or a related field. Master’s or advanced degree (e.g., MSc, PhD, MD) is preferred.

Significant experience in early-phase Clinical Drug Development and Clinical Operations.

*   Minimum 8+ years in the pharmaceutical industry or Contract Research Organizations, including experience leading operational teams.

*   Proven track record in regulated pharmaceutical or healthcare environments with thorough understanding of all phases of drug development (I–IV).

*   In-depth knowledge of protocol development, implementation, monitoring, safety surveillance, and regulatory requirements (ICH/GCP, Code of Federal Regulations, IND/NDA).

*   Experience initiating and leading departmental and cross-functional strategic initiatives.

*   Ability and willingness to travel domestically and internationally (10–20%).

* Experience leading/managing teams in line and/or matrix reporting relationships is required.

Skills and Competencies

Leadership and Team Management:

*   Ability to lead and inspire high-performing teams, including matrixed teams, with or without direct authority.

*   Advanced people management skills, including recruitment, onboarding, performance management, and talent development.

*   Creates a performance-driven culture with clear accountability and urgency for results.

Strategic Thinking and Problem Solving:

*   Anticipates future trends and translates them into actionable strategies aligned with organizational goals.

*   Strong analytical skills and critical thinking to resolve complex challenges and make sound, data-driven decisions.

Project Management and Operational Excellence:

*   Expertise in planning, prioritization, and resource management to ensure timely delivery of clinical trial milestones (site selection, initiation, recruitment, database lock, data quality, TMF completeness).

*   Proven ability to manage budgets, compliance, and productivity metrics effectively.

Communication and Influence:

*   Excellent written and verbal communication skills; clear and concise in diverse settings.

*   Skilled in stakeholder engagement, active listening, and influencing across functions and geographies.

Collaboration and Networking:

*   Builds strong relationships internally and externally; fosters cross-functional collaboration and alignment.

*   Represents Clinical Operations in global/local working groups and strategic initiatives.

Innovation and Digital Acumen:

*   Demonstrates curiosity and innovative thinking to improve processes and trial delivery.

*   Proficient in leveraging digital tools and technologies; strong learning agility in systems (e.g., MS Office, clinical trial and document management systems).

Integrity and Compliance:

*   Adheres to ethical standards and regulatory requirements, ensuring patient safety, data integrity, and organizational reputation.

Customer Focus and Detail Orientation:

*   Excellent customer service skills with high attention to detail and quality standards.

Language and Technology

*   Fluent in English (oral and written).

*   Technology learning agility in systems and processes, with understanding of system support workflows.

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