SENIOR MANAGER CLINICAL DEVELOPMENT

At J&J, we are working to create a world without disease.
Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science.
We collaborate with the world for the health of everyone in it.
The Interventional Oncology (INTO) at Johnson and Johnson, which is a cross-sector initiative, is charged by the Executive Committee of J&J with meaningfully altering the course of lung and other cancers and improving survival by preventing, intercepting, and curing cancer.
We are recruiting for a Senior Manager of Clinical Development in China.
The incumbent will participate and provide inputs in scientific, clinical and operational activities of assigned medical device and or pharmaceutical related INTO clinical studies, potentially including planned and ongoing clinical trials and observational studies of medical device and or pharmaceutical solutions.
Responsibilities include participating in the design of clinical programs and protocols, conduct and supervision of clinical trials guided by highest standards of ethical and good clinical practices, development of clinical relationships with both internal and external partners, development and maintenance of external research focused alliances with academic health centers, analysis and reporting of trial results, publication planning and execution and interactions with China and Asian Pacific regulatory agencies.
The incumbent will also share responsibility for development and execution of a medical affairs and publication strategy in China and Asia Pacific Region.
This position could be either full time or part time depending on the candidate.
ESSENTIAL FUNCTIONS.
(CORE Responsibilities) 1.
Participate in design of clinical trials and design/implementation of protocols to meet those objectives.
2.
Implementation of high standards of research conduct.
3.
Identifying and developing research alliances with key health systems in China and Asian Pacific Region to advance lung cancer research 4.
Participate in the development & execution of medical affairs and publication strategy in China and Asian Pacific Region 5.
Participate in presentations to J&J management as well as at China and Asian Pacific Region regulatory agencies, the public and at scientific meetings.
6.
Maintain liaison with individuals and groups within the organization for purposes of information communication, technology transfer and collaborative work.
This includes the Medical Devices sector (e.
Auris Health, Ethicon and NeuWave) and Janssen Oncology.
7.
Participate in the preparation of clinical portions of regulatory documents including IDEs, INDs, briefing books, Qsub meetings and other regulatory submissions.
8.
Participate in strategic direction setting for INTO in APAC including presentation at INTO Core Team meetings, pillar meetings and in evaluating new business or scientific opportunities.
9.
Ability to work across sectors, across companies, and across countries at J&J This is not an exhaustive, comprehensive listing of job functions.
May perform other duties as assigned.
Location & Travel.
location will be flexible based on the candidate.
Ideally co-located with the INTO APAC team in Shanghai.
The expectation for travel is approximately 30% of time as allowed, including team meetings in locations of INTO sites globally, including US and Europe, as well as travel to investigative sites to work with actual and potential study sites, China and Asian Pacific regulatory agencies, and International scientific congresse Qualifications Physician (MD, or equivalent) and clinical experience in medical oncology, radiation oncology, pulmonary medicine or thoracic surgery is required.
Required Years of Related Experience 3 years of clinical/biomedical research experience (inclusive of residency and fellowship) in or outside of industry setting is required.
· Experience in protocol writing and execution highly desired · Ability to successfully work in a matrixed environment and with both internal and external stakeholders including the pulmonary physician community required · Demonstrated ability to present scientific content to diverse audiences required · Learning agility and ability to works across multiple sectors (pharm, medical device, and or consumer) preferred Previous experience in people leadership preferred