A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
As a strategic geography to the success of Merck KGaA Darmstadt, Gemany, Global Clinical Operations, China is a critical organization to the enabling our company success. Our business, both from a commercial and clinical research perspective, depends on leaders with proven experience in navigating the changing regulatory environment, building strong and lasting relationships with clinical investigative sites and driving performance and quality in the execution of clinical trials in the region.
The primary responsibilities of this role include:
- Provide leadership, strategic direction and oversight of clinical research operations in the territory including people and stakeholder (internal and external) management activities.
- This role is the face of GCO in China for key internal leadership including regulatory affairs; commercial leadership and R&D leadership in the geography.
- Directly leads and manages an integrated, clinical operations team (Clinical Trial Management, & Site Relationship Management) with located at the China HUB that is responsible for all local and, when relevant, regional clinical trial deliverables.
- Closely collaborates with China Data Sciences group to achieve the Clinical Operations deliverables.
- Oversees the local quality management processes, and actively participate in local Clinical Development Leadership and Departmental Team meetings.
- Develops the strategy and drives implementation of local operations to meet both long-term and annual goals.
- Proactively implements measures to ensure the effective delivery of clinical studies, including preparation for the conduct of studies in existing and new Therapeutic Areas, as required by the development pipeline.
- Identifies and implements strategies and tactics to ensure continuous productivity and efficiency gains, and a high performing clinical operations team including but not limited to working with external research opinion leaders to gain information on the design of our programs while developing relationship that foster greater levels of research in the region.
- Contributes to global and local initiatives aimed at increasing quality and delivery of clinical operations activities (both globally and locally).
- In coordination with the local management team to plan and manage all budget- and resource-related activities like strategic and operative planning processes in close alignment with Global Clinical Operations
- Contributes to the global function on behalf of local R&D and aligns with business requirements and objectives while effectively supporting the overall performance of GCO.
Strategy related responsibilities
- Contribute to the formation of China Clinical Development Plans regarding design/feasibility of clinical programs and trials
- Provide and validate of operational details regarding conduct of the studies (time, cost, quality)
- Participates in oversight of our strategic partner (or other CROs) in their assigned territory
- Lead and steer site management as well as central coordination for developing long-term relationships with clinical investigators, enhancing the image and reputation of the company and for providing an interface between the company, the investigator and the service provider across multiple countries
- Where relevant, influence and drive the external regulatory environment as it related to clinical trial conduct.
- Develop and implement the operational strategy in the China hub (productivity, performance management & resourcing model) and consistent with the GCO operating model
- Accountable for ensuring departmental budget forecasts are accurately produced and submitted in time for the functional budget rounds. Ensures adherence to budget forecasts.
- Ensures “best practice” in all activities and effective implementation and optimization of global and local process improvements.
- Ensure optimal interfaces with the other functions contributing for each clinical trial
- Provide suitably qualified and empowered team members to represent China clinical trials and programs
- Ensure adequate resources to meet the project needs
- Provide management oversight working with Head Global CTM, Global Head Data Sciences, Global Head CQM, Global Head RCO, Global Head SPM to ensure delivery milestones are achieved
- Plan, initiate, conduct and report all phases of clinical studies according to agreed time, cost and quality (ICH-GCP standards) out of China hub
- Ensure compliance with internal policies and external regulations, such as GCP in the conduct of clinical trials
- Direct the operational support towards the regulatory submission process with its associated timelines.
- Foster the development of partnerships and collaborations within China at academic institutions and biopharma organizations
Capabilities and People Management
- Future-oriented leadership with a proven track record to adapt operating models to meet the changing external environment.
- Change agent that can work seamlessly in a matrix environment.
- Set people-related goals and priorities for China Clinical Operations with supporting HR plan
- Attract, recruit and retain key staff and contribute to the Talent and Succession Management process
- Foster a patient focused and performance-related culture and provide training in the technical skills needed by employees as a result
- Ensure connection to global clinical operations functions, and learning experiences are shared
Who You Are:
- BS degree, Master degree or PhD / MD (or equivalent) in life sciences (e.g., biology, chemistry, pharmaceuticals, medicine) or health related field
- 12+ years appropriate relevant industry experience
- Excellent oral and written communication skills in English
- Oral and written skills in Chinese are a plus
- Proficient in all aspects of the job ensuring different departmental deliverables are coordinated and effectively produced
- Proven leadership skills from a previous line and / or project responsibility function within R&D
- Excellent understanding of relevant regulatory guidelines (e.g. ICH, FDA, EMEA) and Good Clinical Practice
- Well versed with the clinical regulatory guidelines/requirements specific to applicable therapeutic areas
- Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to clinical and methodological development (incl. cost and finance issues)
- Excellent project management, process improvement abilities, and the ability to coach, mentor and develop people
- Proven experience in clinical research in global and highly matrixed organizations
- Excellent capabilities to understand, manage and lead in a multi-cultural atmosphere
- Excellent understanding of value potential and opportunities of clinical development especially of practical aspects in clinical research
- Teamwork and Collaboration – successful and comfortable working in a complex global matrix, able to seek common ground in an effort to resolve conflicts, able to pull people together around a common goal, and to build diverse teams leveraging them to deliver exceptional results.
- Demonstrated ability to interact with different professional levels of the external clinical research community.
- Solid track record of selection and management of CROs and other vendors as applicable
- Demonstrated success in setting and delivering departmental goals and managing performance through reliable business indicators.
- Ability to travel domestically and internationally as needed.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com