Clinical Leader

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting a Senior Director, Clinical Leader - to be located in New Brunswick, NJ. 

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.  

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Clinical Leader will have responsibility for overseeing Clinical drug development activities for a unique program that is being performed under a government contract. The leader will have responsibilities for Clinical Development of the compound in the areas of Clinical Hematopoietic Stem Cell Transplant, Cell Transplant and Hepatocellular Carcinoma as well as the development of the compound as a radiation and chemical countermeasure. The Clinical Leader will be responsible for design, implementation, conduct, and interpretation of clinical studies (from IND/CTA submission to registration). The Clinical Leader is expected to develop state of the art translational and clinical development plans for this program and lead and direct a cross-functional team to operationalize and execute on the multiple clinical studies as defined in the development plan .

Essential Functions:

• Design state-of-the-art translational and clinical development plans from Phase 1 to Registration.
• Operate with an appropriate sense of urgency and innovative mindset within the team with a goal of successfully developing this drug.
• Lead and guide the clinical team on the execution of the studies as defined in the compound development plan
• Interact and present to regulatory health authorities as well as government agencies
• Serve as a core member of Compound Development Team.
• Build and maintain strong collaborative relationships with leading international academic clinical and translational research centers involved in oncology drug development.
• Promote diversity, inclusion and tolerance within the workspace.

• An MD or MD/PhD, with specialty training in hematology and or oncology required, and board certification preferred
• Minimum of six years of experience in oncology drug development in an industry setting preferred
• A recognized expert in anticancer drug development capable of establishing and maintaining peer-to-peer external collaborations with leading international academic clinical research centers preferred.
• A strong background or familiarity with clinical pharmacology, discovery research, translational or experimental medicine, biomarker applications and cancer biology required.
• Experience interacting with regulatory health authorities at Pre-IND, Phase 2 and/or advisory committee meetings
• Excels at programmatic and strategic thinking in oncology drug development
• Outstanding communication and leadership skills to maximize effectiveness in a highly matrixed organization preferred
• Travel up to 30% both domestic and international will be required.