Danaher Corporation Associate Director, China Clinical Affairs in Beijing, China
The incumbent will also be responsible for, but not limiting to the following duties:
Understands and translates global business strategies into a detailed operating plan for the China clinical affairs function across multiple product lines. Proactively follows key trends that affect each business and leads the clinical organization in executing clinical evidence strategies that are designed to drive regulatory clearance, market awareness and market adoption of Beckman Coulter products across the globe.
Accountable for costs, methods and associates as defined by company policies and procedures. Cultivates a positive work environment that reflects company values, embraces collaboration across functions/businesses/regions/operating companies, and promotes associate development.
Actively participates in industry consortia that shape and influence the global standards that govern clinical research in China. Anticipates key changes and adapts company standard operating procedures (SOPs) with a measurable process to build knowledge and ensure compliance with all applicable company policies, procedures and regulatory standards.
Leads using the Danaher Business System and tools to cultivate new DBS leaders and iteratively benchmark clinical function processes against industry best practice.
Maintains strong, collaborative relationships with business leaders, other functions, key external stakeholders and other operating companies in meeting business goals both at the operating company, business and at the platform level.
Oversees the process for the timely and high-quality preparation of assigned clinical deliverables including internal progress reports (metrics, bowlers, action plans), external reports to support regulatory submissions to the global regulatory agencies and clinical evidence intended for external audiences (e.g. abstracts, presentations, whitepapers, publications).
Oversees the process where the clinical function is actively engaged in the strategic planning, execution and assessment of clinical function deliverables throughout a product’s lifecycle to ensure that products are performing as intended across all regions where the product is registered.
Responsible for talent management of the function including workforce planning to ensure knowledge transfer through systems/processes to retain know-how, building such into programs for development planning of functional capability and onboarding of new personnel. Selects and actively develops managers and associates who value leading with DBS.
Perform other duties as assigned
This position requires directly related experience in Clinical Program planning and execution of Clinical studies in China, including an understanding of clinical strategy, the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory and compliance requirements of clinical research. The candidate must be fluent (speak and write) in the English language. The candidate will have proven track record in leading multi-regional teams. Experience with medical devices or pharmaceutical clinical research is desirable. In addition, this position requires strong leadership competencies & skills in inclusively leading a global team of professionals.
Minimum of 15 years relevant professional experience including:
Clinical Research 15 years
and Supervisory or management experience 5 to 10 years (domestic and international) and
Laboratory (hospital, research, industrial) 5 to 7 years
or Quality Assurance/Auditing 5 to 7 years
or Diagnostic Customer Contact 5 to 7 years
Other: This position requires previous experience leading a portfolio of large or complex multicenter global clinical studies; the demonstrated ability to achieve goals through interaction with individuals not under their direct control; leading international teams; excellent oral and written communication skills; high proficiency with desktop computer office software (MS Office, particularly Word and Excel), ability to travel (30-50% Domestic and international), and participation in professional activities outside of normal business hours
Accountability / Scope:
Collaborates with the Beckman Coulter operating company and associated departments with centers of excellence in the U.S., Western Europe, China and India; additional clinical functional collaborations are required across all operating companies in the Life Sciences and Diagnostics platform.
Regularly engages with business and functional leaders across Beckman Coulter with data that demonstrates the value and accountability of the clinical function in meeting business needs.
Executes a continuous improvement strategy; measures portfolio progress and deploys countermeasures where appropriate.
Ensures Clinical department compliance with applicable policies, procedures and regulations.
Effectively executes training programs for all Clinical Research personnel globally.
Prepares and manages annual budgets for the Clinical Program
Interacts with China NMPA and other worldwide regulatory agencies for specific clinical program issues, to influence the shaping of regulatory standards related to clinical trials or to support regulatory inspection/audit. Anticipates regulation changes and proactively prepares the clinical function and the business for compliance.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .