Deskripsi
Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for an Associate Director, Clinical Project Scientist located in Raritan, New Jersey; Spring House, Pennsylvania or San Diego, California. Remote work options within the United States may be considered on a case-by-case basis and if approved by the company.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Associate Director, Clinical Project Scientist (CPS) works in the Oncology Therapeutic Area Development group and will actively participate and may lead aspects of the development, oversight, and execution of Ph I-IV clinical research trials working closely with Study Responsible Physicians, Clinical Leaders, and other Clinical Project Scientists. The position reports to a more senior Clinical Project Scientist.
Essential Functions:
· In collaboration with the Study Responsible Physician and Clinical Leader, will actively participate in or lead aspects of, medical review of clinical trial data, including adverse events, efficacy data, patient screening/eligibility evaluation, PK/PD data, coding, and other data critical to study endpoints
· Participate or may lead drafting protocol synopsis, sections of full protocols, informed consent documents, review, and development of Case Report Forms (eCRFs), and other data collection tools against draft protocols and central vendor scope of work
· Participates in the start-up and day to day management of one or more global clinical studies, in compliance with department safety practices, policies, and procedures
· Partner or lead Cross Functional Trial Team to mitigate issues in initiation and management of one or more clinical trials and participate in review of Monitoring Guidelines, SET/IDMC charter, Statistical Analysis Plan, Data Management, and Safety Management Plans
· Performs medical monitoring/reporting, evaluates ongoing clinical trial data
· Liaise with external vendor laboratories and clinical research organizations to develop charters where applicable and ensure the collection and quality of data critical to study endpoints
· Liaise with Translational Research (pharmacokinetic operations & biomarker operations) to ensure robust sample collection, processing, and tracking
· Participate in the creation and maintenance of a robust Medical Review plan, medical review forms, and liaise with Integrated Data Analysis & Reporting in set-up, implementation, and maintenance of data visualization tools/medical review interface
· Participate in or lead aspects of training the central study team, local study team, site personnel or external vendors on protocol, disease evaluation criteria, or other specific aspects of the clinical study
· Participate and lead aspects of data review and drafting documents for submission to Health Authorities
· Actively participate in mentorship and training opportunities to expand clinical development knowledge, therapeutic area expertise, and leadership capabilities
Principal Relationships:
Contacts within the Company:
· Members of the Clinical and Cross Functional Trial teams
· Members of Oncology TA
Contacts outside the Company:
· May act as a liaison, in partnership with other Clinical Project Scientist(s), Study Responsible Physician(s) and Global Operations, between company and Investigators, Site Managers, Site staff, global clinical research staff, vendor project managers, and CROs
Kualifikasi
Education and Experience:
· Minimum of a bachelor’s degree in a scientific discipline required, with advance degree (i.e., MSc, Ph.D., or Pharm D) preferred
· A minimum of 4 years of experience in a related clinical research position, spending at least part of the time within the pharmaceutical industry with leadership experience is preferred.
· Significant knowledge of basic scientific research including clinical oncology research is important
Required Technical Knowledge and Skills:
· High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards.
· Successful work experience in a matrix team, environment with global cross functional teams is required
· Fluent in written and spoken English with excellent oral and written communication skills
· Working knowledge of the use of Microsoft suite of software products
· Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality oncology clinical trials including protocol development, medical review, oversight of safety, study conduct, and data quality
· Ability to travel approximately 10-20% domestic/international travel may be required
The anticipated base pay range for this position is $131,000 to $225,400. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.