Johnson & Johnson Careers
Senior Clinical Scientist, PH
Requisition ID: 9927190716
Actelion Pharmaceuticals Ltd is recruiting for a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Clinical Scientist, PH located in Cherry Hill, NJ
Actelion Pharmaceuticals Ltd, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a leader in the science and medicine of pulmonary arterial hypertension (PAH), with over 20 years of experience in this devastating cardiovascular disorder. Our portfolio of PH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications. Learn more at www.actelion.com.
The focus of this position is to plan, design, scientifically monitor and report clinical studies.The incumbent is responsible for the compliance of the assigned clinical study(ies) with department, company and regulatory standards and procedures. Responsibilities include:
- Is responsible for delivering the clinical study protocol and contributes to the development of other clinical study documents, e.g. Informed Consent Form, Case Report Form, etc.
- Plans, manages and monitors daily activities of clinical studies which require scientific input, e.g. contribution to answers to trial-related Health Authorities' (HA) questions, answer to Ethic Committees /Institutional Review Boards questions
- Performs medical monitoring/ reporting including evaluation of adverse events.
- Reviews, evaluates and reports results of clinical studies.
- Manages study-related committees, external medical experts etc.
- Ensures that all activities are in compliance with department, company and regulatory standards and procedures
- As requested, contributes to the development and execution of clinical research programs for assigned company products, e.g. Clinical Development Plans, Clinical Overviews, HAs' Briefing Books, HAs' Annual Reports, Pediatric Investigational Plans
- As requested, participates on cross functional teams, e.g. improvement of processes
Minimum 5 years experience in Clinical Development, and hands on experience on conducting clinical trials are required.
Knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH guidelines based on previous deliverables is required.
Prior experience of working in a matrix organization including interactions with all relevant functions involved in a clinical trial and program (e.g. Biostatistics, Data Management, Operations, Regulatory, Drug Safety, external service providers, etc.) is preferred.
- Good leadership skills are required.
Demonstrated analytical skills are required.
Excellent computer systems and software skills are required.
Good organizational skills, good written and verbal communication skills, detailed oriented, able to work as part of a team and independently are required
Ability to plan and track deliverables and timelines are required
Ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business are required.
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
United States-New Jersey-Cherry Hill-
Janssen Research & Development, LLC (6084)
Clinical Research non-MD