Medical Director/ Sr. Medical Director, Clinical Development

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Janssen Research & Development, L.L.C, a member of the Johnson & Johnson Family of Companies, is recruiting for a Director/Senior Director, Clinical Rseearch Physician for Late Development Oncology .

Up to 25% travel may be required.

Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Medical Director/Senior Medical Director-Clinical Research-Prostate.

They will be a member of a matrix team dedicated to the implementation of clinical research studies that are part of a global compound development program.

Responsibilities include:


* Leads execution of research programs for an area of clinical development to meet research objectives, support product development, and manage reports.


* Acts as the clinical functional head for providing active scientific contributions to a cross-department compound development team.


* Works in close partnership with the Compound Development Team (CDTL) and project management, global regulatory affairs, clinical pharmacology, health economics, and the disease area leader to share information.


* Acts as a liaison between the company and the clinical investigators, evaluates scientific information, and creates new ideas to assist in identifying new research opportunities.


* Develops the strategy and content for scientific communications for assigned compound through close partnership with the compound global medical affairs leader.


* Serves as the clinical leader for product evaluation and develops the strategy and the content for regulatory documents.


* Works with senior clinical staff, establishes credible relationships with external stakeholders such as opinion leaders and regulators, and provides substantial expertise in drug development (including experience with IND and NDA submissions).


* Able to manage study start-up, and directs and guides study team in study execution, data cleaning, medical review, database lock, managing health authority responses.


* May provide determination of pathology diagnosis and act as a signatory to primary and peer review pathology reports.


* Develops a goal-oriented clinical development team.


* Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.


* Proactively creates a purpose driven environment by aligning John...