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, Translational & Experimental Medicine, Cardiovascular/Metabolism (CVM) located in Raritan, NJ.
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 oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Director will provide clinical and operational support to the Clinical Leaders in the Cardiovascular/Metabolism (CVM) Translational & Experimental Medicine Group, with a focus on drug development for cardiovascular and metabolic projects. The Associate Director will have broad responsibilities including:
- Support clinical research strategies and contribute to the development and execution of early development clinical research programs for novel drug candidates.
- Supervise the initiation, execution and reporting of Phase I and IIa clinical trials for novel drug candidates within Early Development/Translational Medicine department of J&J Pharmaceutical Research & Development.
- Support development of essential study documents, including protocols and protocol amendments, case report forms, and informed consent forms and ensure overall execution of clinical studies.
- Maintain accountability for the end-to-end execution process (from protocol to completion of study report) for each clinical assigned project.
- Assemble and co-chair clinical trial teams to coordinate the activities of clinical trial team representatives from supporting Pharmaceutical Research & Development clinical departments (Biostatistics, Data Management, Clinical Operations, Medical Writing, Regulatory Affairs) to ensure all clinical study objectives are achieved.
- Represent clinical trial team functions as an ad hoc member of Compound Development Teams for new Pharmaceutical Research & Development drug candidates.
- Manage interactions with all partners (internal Pharmaceutical Research & Development departments and external contractors, investigators etc.) to facilitate successful conduct of Phase I and IIa clinical trials.
- Evaluate and select clinical study research centers and appropriate investigators - in collaboration with Global Clinical Data & Operations and the Translational Medicine team, and other J&J clinical departments.
Liaise with clinical investigators and the site(s) to develop credible relationships with key stakeholders.
- Providing strategic leadership on managing/addressing specific project/program-related issues
Responsible for data review and medical monitoring/reporting activities, in concert with the Clinical Leader, to evaluate adverse events for relationship to treatment. May support the interpretation, reporting of results, and preparation for worldwide health authority submissions.
- Additional responsibilities include providing input and support for other metabolic development clinical programs and maintaining expertise in metabolic diseases and in relevant clinical research methodologies
Qualifications for the Associate Director position include:
A Master's degree is required and a CNRP, PharmD or PhD is preferred.
Previous experience with human trial conduct with pharmaceuticals, devices, basic clinical practice with the precepts of Good Clinical Practice (e.g. Study Coordinator; Regulatory Associate; Data Management Specialist) is preferred.
Previous experience working on Clinical Trial and/or Compound Development Teams in a matrix management organization is preferred.
Strong leadership skills preferred
Detailed and thorough understanding of metabolic disorders, including diabetes and obesity, in drug development diabetes, and in methodology relevant to clinical research in diabetes and metabolic disorders is a strong asset.
Requires at least 5 years of experience (academia or industry) in clinical research and/or development. Drug development experience is a plus.
Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings are required.
Up to 10% annual travel (domestic and international) may be required.
United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function