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Executive Medical Director, Clinical Leader
Johnson & Johnson
New Brunswick, NJ, United States
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Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting an Executive Medical Director, Clinical Leader. The preferred location is New Brunswick, NJ however consideration can be given to other North America sites. Up to 30% domestic and international travel is required for this position. This is a project based role contingent upon project based funding.
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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Executive Medical Director, Clinical Leader, will have responsibility for overseeing the Clinical Hematopoietic Stem Cell Transplant (HSCT) and/or Hepatocellular Carcinoma drug development activities for a unique program that will be performed under a BARDA government contract. The BARDA contract is for the development of the drug as a radiation and chemical countermeasure as well as an Oncology drug for treatment of patients with Hepatocellular Carcinoma and patients with hematologic malignancies undergoing allogeneic bone marrow transplant.
The Executive Medical Director,Clinical Leaderwill be responsible for design, implementation, conduct, and interpretation of the HCC oncology and/or HSCT studies (from IND/CTA submission to registration) and supporting the translation of the animal data to humans to obtain approval for the biodefense indications under the Animal Rule. The Clinical Leader is expected to oversee multiple studies and to design state of the art translational and clinical development plans for this program.
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.
• Interacting with regulatory health authorities
• 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 HCC oncology drug development.
• Promote diversity, inclusion and tolerance within the workspace.
Qualifications
• An MD/PhD, or equivalent with specialty training in hematology and/or oncology required; board certification is preferred.
• Minimum of four years’ experience in oncology drug development in an industry setting is preferred.
• A recognized expert in anticancer drug development capable of establishing and maintaining peer-to-peer external collaborations with leading international academic clinical and translational research centers is preferred.
• A strong background or familiarity with clinical pharmacology, discovery research, translational or experimental medicine, biomarker applications and cancer biology is required.
• Experience interacting with regulatory health authorities at Pre-IND, Phase 2 and/or advisory committee meetings is preferred.
• Experience in radiation Oncology is a plus.
• Excels at programmatic and strategic thinking in oncology drug development is required.
• Outstanding communication and leadership skills to maximize effectiveness in a highly matrixed organization is preferred.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.