Director Clinical Research (MD) EnVivo Pharmaceuticals
EnVivo Pharmaceuticals is seeking a Medical Director/Director of Clinical Research with Psychiatry or Neurology experience to join the EnVivo Clinical Research Team. He/She will have the opportunity to work on a compound in late-stage development providing leadership and Medical/Clinical oversight for multiple clinical trials. Further opportunity exists to work on Phase I through IV studies across multiple programs.
Major duties and responsibilities include:
Responsible for medical oversight of Phase II and III human clinical trials for company products under development for CNS indications.
May have similar responsibility for phase I ? IV clinical trials.
Provides scientific and medical input across the clinical development program including strategy, planning, execution and interpretation of clinical trials.
Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports, working closely with clinical operations.
Coordinates and contributes to medical, scientific and safety information for regulatory documents submitted to the Food and Drug Administration and international Regulatory Authorities including but not limited to possible NDA and MAA filings.
Provides medical assessment in adverse event reporting and safety monitoring.
Represents EnVivo to clinical research and academic leaders, providing specific disease-area and drug development expertise. Coordinates scientific exchange of ideas through direct interactions and expert advisory boards.
Interacts with EnVivo basic research team to provide specific medical input and disease-area expertise for early research projects. May facilitate transition of research to clinical development
May act as consultant/liaison with other corporations when working under licensing agreements.
Travel required to interact directly with clinical trial sites on an as needed basis, and attend scientific conferences.
MD degree with specific training in Psychiatry or Neurology.
3+ years of drug development experience within a pharmaceutical or biotechnology company including Phase II or later study experience. Experience in schizophrenia or Alzheimer?s Disease desired.
Demonstrated ability to prioritize, plan, and execute clinical trial objectives with high quality results.
Ability to work in a dynamic environment that fosters collaboration and innovative thinking.
Strong problem solving skills; ability to influence and make recommendations across multiple levels of the company.
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