Janssen is recruiting for an Associate Director, Clinical Scientist, in the Translational & Experimental Medicine Group within the Cardiovascular & Metabolism (CVM) Therapeutic Area 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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Clinical Scientist will provide clinical and scientific support in all aspects of early stage clinical studies including the design, preparation, conduct, monitoring, analyses, and reporting. Early stage clinical studies encompass Phase 0 through Ph2a clinical trials, including mechanistic studies. Medical monitoring of clinical pharmacology studies is also required.
- Bring to bear scientific background to collect, translate, summarize and draft individual study concepts/strategies into study designs, in collaboration with the Study Responsible Physician (SRP), to drive protocol development
- Lead role in authoring the protocol synopsis, clinical study protocols, and relevant sections of the IB, regulatory documents, CSR, and other critical clinical study documents, in close collaboration with the SRP and in partnership with supporting departments within JRD
- Participate in Document Review Committees, Protocol Review Committees and FIH Committee meetings and incorporate the recommendations from these committees and from IRBs and regulatory agencies into study protocols
- Accountable for clinical study protocol amendments
- Perform site initiation visits, medical monitoring/reporting activities, in collaboration with the SRP, to evaluate screening results, adverse events, PK/PD data, and other study endpoints
- Coordination and execution of Biomarker strategy in early phase clinical studies in collaboration with Discovery Biomarker
- Contribute to data analysis and interpretation
- Present data internally to partners and externally to academic collaborators through presentations and contributions to publications
- Represent clinical team functions as an ad-hoc member of Compound Development Teams
- Supports Clinical Leaders in the design of the Clinical Development Plan and strategy documents including the Translational Early Development Plan
- Manage interactions with partners to facilitate successful conduct of clinical trials including internal sponsored studies and collaborative research studies with external partners.
- Evaluate and select clinical research centers and appropriate investigators in collaboration with the SRP and other JRD partners
- PharmD, PhD, advanced clinical degree (i.e., Nurse Practitioner) or clinical degree (i.e., RN), required
- Requires at least 2 years of experience in early development clinical research and development (including Phase 0-2a studies). Early phase drug development experience in the field of cardiovascular, metabolism or retinal diseases is preferred.
- Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings is required
- Good project management skills and ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
- The ability to work under pressure to meet deadlines, the ability to handle complex projects and to overcome delays and obstacles, and excellent team member and interpersonal skills is required
- Previous experience working on Clinical Trial and/or Compound Development Teams in a matrix management organization with familiarity in key clinical research tasks including protocol authorship, trial execution and CSR authorship is preferred
- Previous knowledge of Janssen SOPs is preferred
- Fluent in written and spoken English
- 10-20% Travel 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-Raritan-
Janssen Research & Development, LLC (6084)