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 Job #02964 Email this job to a friend
About our client
Our client is a molecular imaging company based in Northeast US. They focus on developing diagnostic agents to enable early diagnosis, treatment selection and therapeutic monitoring of serious chronic diseases. They have an outstanding management team with extensive imaging and CNS development experience, as well as a strong pipeline of candidates in clinical trials to detect Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's disease and diabetes mellitus. This is a unique opportunity to help build an organization from the ground up!
Position Location
Director of Clinical Development Philadelphia, Pennsylvania
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Contribute to designing, conducting and interpreting clinical trials with novel imaging agents
2) Assist other members of senior management and the Clinical Team to prepare clinical trial protocols, Investigator’s brochures, INDs and other regulatory submissions leading to product registration
3) Serve as Medical Monitor and Project Director for one or more clinical trials
4) Address inclusion/exclusion questions, adverse events/product safety and other protocol-related issues
5) Provide internal expertise in neurology, psychometrics and/or neuroradiology
6) Represent the company at scientific meetings and at investigational sites
7) Provide strategic input as well as help train staff in disease characteristics and assessment and/or conduct and interpretation of PET scans
Requirements
1) MD (preferred) with specialization in Radiology, Nuclear Medicine or Neurology
2) Experience in conducting clinical research (as an Investigator/Sub-Investigator) in a pharmaceutical company
3) In-depth knowledge of GCP, ICH and US federal regulations (21CFR)
4) Excellent communication skills (written and oral)
5) Ability to function in a fast-paced team environment

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