Janssen Research and Development, L.L.C., a member of Johnson and Johnson’s Family of Companies, is recruiting for an Associate Director, Clinical Development, Immunology, to be located in Cambridge, MA, Spring House, PA, or San Diego, CA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo. https://www.jnj.com/credo/
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The focus of the Associate Director/Study Responsible Scientist (SRS) is to support various clinical research tasks associated with assigned Immunology Development clinical trials. Scope of work will include tasks associated with the execution, monitoring, and reporting results of clinical trials evaluating therapeutics in immunologic disorders. The range of tasks may vary to some degree depending on the therapeutic area and trial-specific requirements.
The Associate Director/SRS is a key member of development clinical trial teams and leads the team designing and execution of clinical studies outlined in the product development plan (PDP). This work is at its core a deep collaboration between Disease Area experts, Early and Late Development, Translational Science (Biomarker) experts, Immunologic Pathway experts and many other essential development functions. The SRS partners with Global Development Operations (GDO) and the entire Trial Team to efficiently and effectively operationalize the studies. The Associate Director/SRS will also work closely with cross functional partners to support clinical development programs.
Responsibilities Include
- Activities which support the execution, monitoring, and reporting of clinical trials.
- Member of the cross-functional clinical trial team for assigned studies.
- Participation in the development of clinical study documents (e.g., protocols, informed consent documents, case report forms).
- Support activities related to the start-up and execution of new clinical trials.
- Performing clinical data review and assist in the preparation of clinical safety presentations and reports.
- Set up medical monitoring data review activities.
- Tracking of safety events, review of new SAEs, and composing adverse event Narratives.
- Support preparation of the clinical content of drug safety documents and reports such as the investigator brochures, DSURs, and other regulatory response documents.
- Assist with managing other vendor activities such as laboratory, histology or imaging.
- In collaboration with GDO, identifying clinical sites and CROs that will participate in trials.
- Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies.
- Review incoming data from the study for accuracy and completeness.
- Participate in the review and interpretation of clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
- Participate in the preparation and assure the accuracy of the clinical study report and any external publications.
- Report the status of clinical trials to management.
Qualifications
- BS, MS, PharmD, PhD or RN preferably with a scientific background in Immunology or a related field, and 3-10 years industry experience or equivalent clinical research experience is required.
- Experience with Ph 2 and Ph 3 studies in immunology indications is preferred.
- Ability to survey and interpret the scientific literature related to the assigned projects is required.
- Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
- Good interpersonal skills and the ability to advise, persuade, and negotiate with colleagues in a supportive and encouraging fashion.
- Excellent written and verbal English communication skills.
- The ability to work in a global matrix organization with cross-functional teams is required.
- Willingness and ability to travel including international travel is required.
- Proficient with Microsoft Office applications EXCEL, POWERPOINT, and WORD.
- Up to 15% domestic/international travel may be 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.
IMPACTIMM
Primary Location
United States-Massachusetts-Cambridge-MA Cambridge Binney
Other Locations
North America-United States-Pennsylvania-Spring House, North America-United States-California-La Jolla
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2105904235W