job summary:
**
IMMEDIATE NEED for an Associate Director/Director, Medial Monitoring in the Princeton, NJ area. Must be an MD or DO, be able to speak Mandarin, and have at least 3-5 years of experience in Medical Monitoring.**
location: Princeton, New Jersey
job type: Permanent
salary: $180,000 - 200,000 per year
work hours: 9 to 5
education: Doctorate
responsibilities:
- Leads development of clinical sections of trial and program level documents (e.g., clinical synopsis, protocols and amendments, Investigator's Brochures, safety updates, submission dossiers, and responses to Health Authorities).
- Medical support to the clinical study team and provide appropriate medical monitoring for clinical studies
- Ensure the study-related safety of the subjects in the clinical trials through appropriate medical monitoring of studies on a proactive and ongoing basis
- Evaluate pharmacology, safety and efficacy data from ongoing and completed studies
- Interface with clinicians/investigative sites for protocol-related issues, including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
- Perform review and clarification of trial-related Adverse Events (AEs)
- Perform medical case review of Serious Adverse Events (SAEs) including review of case documentation, and patient narrative
- Conduct literature reviews and prepare summaries to support clinical development programs
- Be a medical resource for design and interpretation of clinical and preclinical programs to support existing and new development pipelines
- Evaluate potential business development opportunities and conduct due diligence for assessing scientific, medical and development feasibility
- Interact with key opinion leaders related to assigned compounds and therapeutic area
- Contribute to NDA and EMA filings and prepare relevant sections of the regulatory documents
qualifications:
- MD or DO with experience of agency communication preferred
- At least 3-5 Years of experience in clinical development or medical monitoring
- Clinical practice including post-graduate direct patient care experience; Board certification or equivalent, neurology or psychiatry preferred
- Ability and desire to work in a team-oriented environment and work effectively with cross functional teams
- Excellent verbal, writing, presentation, and editing skills
- Knowledge in FDA, EMA, PMDA and other regulatory requirements, GCP/ICH
skills: CRF, FDA, Clinical research, CRFs, GCP (Good Clinical Practice), SAE (Serious Adverse Event), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.