Senior Director / General Manager, US Site
Genetron Health is a leading and fast-growing precision oncology company that is committed to providing a one-stop, multi-scenario genomic profiling solutions in areas including early cancer screening, diagnosis and monitoring as well as biopharmaceutical services. It has successfully developed seven NMPA-approved clinical sequencing platforms and gene assays. Partnering over 500 hospitals along with several pharmaceutical companies and research institutions, Genetron Health has built an extensive proprietary genomic database to deliver comprehensive genomic testing services. In China, the company has one R&D center, two manufacturing facilities and five clinical laboratories in Beijing (CLIA-certified and CAP-accredited), Shanghai, Hangzhou, Chongqing and Guangzhou. Its world-class team of scientists has also published many research papers in prestigious scientific journals worldwide.
The company is opening a new R&D center and a CLIA lab in Gaithersburg, Maryland, USA with the following exciting opportunities. Genetron Health Inc offers a family friend work environment, competitive compensation package including paid leave, health/dental insurance, 401(k) with company matching contribution, and annual cash/stock incentive awards. Genetron Health Inc. is an equal employment opportunity employer, and does not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
The Senior Director/ General Manager is responsible for the new expansion of GHI US site in MD, the overall research and development, business development and clinical testing functions for the US/global Business Unit(s). This is an opportunity to build and grow a world class lab operation, focused on the early detection of cancer and cross-border pharma services. This position has a critical role in helping Genetron Health Inc (GHI) to achieve its mission by providing senior leadership to the organization, with specific focus on development and implementation of business and financial strategies for the organization, monitors goals and adjusts policies to meet them, works closely with corporate executives to ascertain goals, and advises about staffing and other organizational resources.
Being responsible for building and overseeing a portfolio of precision oncology programs for the US/global business unit(s)
Provide strategic leadership and direct oversight of technology R&D/licensing, business development, in vitro diagnostics (IVD) product development and clinical testing services aligned with the GHI mission
Identify strategic opportunities to build a sustainable and profitable business in compliance with federal laws and local regulations and consistent with corporate goals.
Develop strategic goals, key performance indicators, annual operations plans and departmental budgets
Recruit and maintain a high functioning team of staff
Conducts regular financial and enterprise initiative reviews with senior leaders to ensure that performance and initiatives are tracking to plan
Drives the annual business planning process including the establishment of enterprise and/or area goals, strategies, key performance indicators, and metrics
Reviews and recommends benefits and other employee services to ensure competitiveness and employee satisfaction
Identify effective strategies to achieve organizational and department communications goals
Identifies opportunities to achieve goals for various stakeholders and prioritizes projects appropriately to meet deadlines
Ensures the consistent applications of established HR practices, policies, and tools
Embodies the Company’s Core Values, sets an example for effective management and leadership, and establishes policies and programs to promote the Company culture
Lead multidisciplinary scientific teams in product development programs and projects, coordinating between stakeholders (e.g., Regulatory, Quality, Clinical, Commercial etc), with direct oversight of the teams responsible for pipeline research, bio-analytical science and formulation, preclinical research and process development teams;
Provide overall leadership to the Research and Development team to drive discovery and development of diagnosis assays and products.
Plan, implement and supervise discovery, preclinical and clinical validation studies to ensure study deliverables are met according to specified timelines, budgets, quality and resources
Ensure best-practices for research and data integrity standards are integrated in research and development strategies;
Maintain quality control and high standards throughout the lifecycle of each project, identifying areas of best practice and process improvement
Build strategic partnerships and alliances to advance strategy, build pipeline and enhance capabilities
Lead and mentor multidisciplinary scientists and function leaders to develop a high-performance team and a culture of integrity and accountability
Oversee regulatory strategy and regulatory submissions for IVD products.
Ensure optimal intellectual property strategy is integrated into development and life-cycle management programs to deliver long-term value from product portfolio
Leads due diligence and scientific assessment of business opportunities.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills:
· Ph.D., M.D., or equivalent; an additional MBA degree a plus
>10 years working experience in industry with a proven track record of providing strategic oversight for R&D, preclinical and clinical study protocols, reports and/or publications
Demonstrable expertise relating to all aspects of the in vitro diagnostics development processes, especially in the area of companion diagnostics and personalized medicine
Ability to identify and resolve complex methodological issues relating to programs
Good knowledge of GLP, GCP and regulatory requirements (especially FDA)
Well-developed organizational and interpersonal skills, complemented by attention to detail
Able to find practical and pragmatic solutions in a business environment with strict regulatory control
Finely honed written and verbal communication skills, underpinned by the ability to present clear instructions/directions to teams within the organization and external audiences
Possess both scientific curiosity and ability, and business acumen.