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Posted: Friday, July 14, 2017 3:06 PM

Description

The WAVE Early Development group is recruiting for a physician-scientist to serve as Associate Director, Clinical Research, working on compounds with diverse indications in early stages of development, from First-in-Human/Phase 1 until Proof of Concept. As a member of the cross-functional Study Team, this position will share in the responsibility for the development and execution of early stage clinical projects.

The Associate Director supports the Medical Leader/Clinical Leader and provides active medical and scientific contributions to a cross-functional clinical team developing a compound currently being studied for new applications.
The role requires a high-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to clinical research and the highest personal and ethical standards.

The Associate Director, Clinical Research will be responsible for the following:
• Assist with the design, protocol writing, and conduct of early clinical Phase 1 and Proof-Of-Concept development trials
• Assess clinical safety and efficacy data, and write clinical study reports, clinical sections of INDs, sections of protocols, Investigator Brochures, and other clinical documents.
• Participate in the interpretation and reporting of the results of the research, including submission to health authorities.
• Working closely with biomarker, discovery and translational research scientists.
• Interpreting preclinical and clinical reports, prepare oral and written summaries of compound results, and participating in the discussion of early development strategies.
• Familiarity with clinical and translational research including biomarkers and correlative laboratory clinical trial endpoints.
• Collaboration with relevant functions within Janssen Pharmaceutical R&D, including medical writers; Discovery, translational, and biomarker research scientists; toxicologists, clinical pharmacologists, drug safety specialists, as well as operational personnel, and other support functions.
• The ability to communicate effectively with basic laboratory scientists and clinical teams is essential.
• Supporting strong working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners.
• Some travel (domestic and international) may be required (up to 10%).


Qualifications
• An MD with significant scientific research experience is required.
• Formal training in a medical specialty with a strong background in Internal Medicine is required.
• Certification, or eligibility for certification, by an American Specialty Board or foreign specialty (equivalent to American Specialty Board), is required.
• A minimum of 2 years’ experience in relevant clinical research within the pharmaceutical industry or academia is preferred
• Strong oral, written communication and presentation skills (including report development) are required.
• Successful work experience in a matrix team environment with cross functional teams is required.
• The ability to use influencing skills is required.
• Significant knowledge of translational and clinical research and its application to drug development is required.
• A working knowledge of the key areas of early drug development, including chemistry, biology, toxicology and early clinical development is required.
• Knowledge of clinical pharmacology and its relationship to decision making in early drug development is required.
• Understanding of basic regulatory health authority expectations is required.
• A strategic understanding of the drug development process will be very valuable is preferred.

Primary Location
United States-California-San Diego
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Research MD
Requisition ID
6640170329

Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=6640170329&lang=en


• Location: San Diego

• Post ID: 29466503 sandiego
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