Provide medical direction for the conduct of early clinical trials
Support the development activities of proposed and ongoing projects in their area of expertise
Provide oversight of medical monitoring activities to ensure timelines and quality of medical deliverables
Assign physician resources as required
May serve as Global, Regional or Program Lead Project Physician across multiple indications
Provide subject matter and drug development expertise and is a key contributor to the medical strategy and execution of the study/program for the client
Provide input, review and revision of protocols, case report forms, training materials, project specific tools, analysis plans design, clinical trial reports and new drug applications.
Prepare materials for and actively participate in investigator meetings and assist at site initiation visits
Provide medical/scientific expertise to project team.
Requirements
MD Degree
Relevant specialty/sub-specialty fellowship training/degree and active US MD license / Board Certification required
3+ years substantial knowledge of drug development and extensive clinical research experience within the pharmaceutical/CRO industry in a specific therapeutic area preferred.
Industry experience inclusive of clinical trials medical monitoring experience or other relevant clinical development/trial experience at a CRO, pharmaceutical company, regulatory agency or clinical practice preferred.
Recognized as a clinical research leader with substantial knowledge of drug development and extensive clinical research experience within the pharmaceutical/industry in a specific therapeutic area, which can be a substitute for the board certification specialization, as appropriate.
Benefits
Medical
Dental
Vision
Life
STD/LTD
401(K)
Paid time off (PTO) or Flexible time off (FTO)
Company bonus where applicable
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical monitoringclinical trial designprotocol developmentcase report form designanalysis plan designclinical trial reportingdrug development expertiseproject managementinvestigator meeting preparationsite initiation visit assistance