$100K - $150K(Ladders Estimates)
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Janssen's WAVE Early Development group is recruiting for a physician-scientist to serve as Associate Director, Clinical Research, evaluating and progressing compounds with diverse indications through 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 novel compounds for important unmet medical needs.
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 has the following role responsibilities:
Assist in the design, protocol writing, and conduct of early development (Phase 1 through 2a) clinical trials. The degree of responsibility will progress as experience is gained.
Monitor and report on clinical safety and efficacy data.
Write clinical study reports, clinical sections of INDs, sections of protocols, Investigator's Brochures, and other clinical documents.
Contribute to the interpretation and reporting of the results of clinical trials, including submission to health authorities.
Interpret preclinical and clinical reports, prepare oral and written summaries of compound background and clinical results, and participate in the discussion of early development strategies.
Understand clinical and translational research including biomarkers and correlative laboratory clinical trial endpoints.
Collaborate with drug discovery and development 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 toward streamlined and robust clinical study design and documentation.
Communicate collegially and effectively with laboratory scientists and clinical teams.
Support strong working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners.
An MD degree with a minimum of 2 years of scientific research experience.
Formal training in a medical specialty with a strong background in Internal Medicine.
Certification, or eligibility for certification, by an American Specialty Board or an equivalent foreign Specialty Board.
Strong oral, written communication and presentation skills (including technical report writing).
Successful work experience in a matrix team environment with cross-functional teams.
The ability to use influencing skills.
Significant knowledge of translational and clinical research and its application to drug development.
A working knowledge of the key areas of early drug development, including chemistry, biology, toxicology and early clinical development.
Knowledge of clinical pharmacology and its relationship to decision-making in drug development.
Understanding of basic domestic and foreign Regulatory Health Authority expectations.
Facility with MS Word, MS Excel, MS Powerpoint, and experience with biostatistics and graphical presentation of data.
Qualifications: Strongly preferred
A strategic understanding of the drug development process.
A track record of scientific publication.
A minimum of 2 years' experience in relevant clinical research within the pharmaceutical industry or academia.
Valid Through: 2019-10-11