J&J Family of Companies Associate Director, Clinical Research - Early Development in San Diego, California
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Clinical Research to join our WAVE Early Development group, located in San Diego, CA (San Diego area). US based remote candidates may be considered.
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 (file:///C:/Users/jamie%20yacco/AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Janssen’s WAVE Early Development group is recruiting for a physician-scientist to serve as Associate Director, Clinical Research, working on compounds with diverse indications in early stages of development, from First-in-Human/Phase 1 until Proof of Concept. As a member of the cross-functional Study Team, this position will share in the responsibility for the development and execution of early stage clinical projects.
The Associate Director reports to the WAVE Team Leader and provides active medical and scientific contributions to a cross-functional clinical team developing a compound currently being studied for new applications. The role requires a high-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to clinical research and the highest personal and ethical standards.
The Associate Director, Clinical Research will be responsible for the following:
Assisting with the design, protocol writing, and conduct of early development (Phase 1 Proof of Concept) clinical trials
Real-time monitoring and reporting on clinical trial safety data
Writing clinical study reports, clinical sections of INDs, sections of protocols, Investigator’s Brochures, and other clinical documents
Participating in the interpretation, reporting and presentation of the results of the research, including submission to health authorities
Interpreting and synthesizing preclinical and clinical reports, preparing oral and written summaries of compound data packages
Contributing to the discussion of early development strategies
Collaborating productively with Global Medical Safety, Therapeutic Area representatives, and clinical trial functional partners.
Maintaining close collaboration and collegial relationships with relevant functions within Janssen Pharmaceutical R&D, including medical writers; Discovery, translational, and biomarker research scientists; toxicologists, clinical pharmacologists, statisticians, drug safety specialists, as well as operational personnel, and other support functions
Developing collegial relationships and successful collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners
An MD, or country specific MD equivalent is required
Certification, or eligibility for certification, by an American Specialty Board or foreign specialty (equivalent to American Specialty Board), is strongly preferred
A minimum of 2 years’ experience in clinical trial research within the pharmaceutical industry or academia is required
Scientific research experience is preferred
Formal training in a medical specialty with a background in Internal Medicine is preferred
Successful work experience in a cross-functional team with matrixed reporting relationships is preferred
A working knowledge of the key areas of early drug development, including biomarkers, chemistry, biology, toxicology and early clinical development is required
Knowledge of clinical pharmacology and its relationship to decision making in early drug development is required
Familiarity with clinical and translational research, including biomarkers and clinical trial endpoints is required
Understanding of basic regulatory health authority expectations is required
Significant knowledge of translational and clinical research and its application to drug development is required
A strategic understanding of the drug development process is strongly preferred
A solid medical/scientific publication track record is preferred
Excellent oral, written communication and presentation skills (including technical writing of reports) are required
The ability to use influencing skills is required
This position has a preferred located of San Diego, CA (La Jolla area), with consideration for remote candidates, and may require approximately 10% travel (domestic and/or international).
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-California-San Diego-3210 Merryfield Row
North America-United States
Janssen Research & Development, LLC (6084)