What are the responsibilities and job description for the Senior Clinical project manager position at cGxPServe?
Job Description
The successful candidate will lead investigation of innovative device-based drug delivery solutions to improve tissue exposure when systemic delivery does not fully exploit the potential of our drugs. In close collaboration with partner functions in Discovery and Development Biological Sciences, the incumbent will develop a thorough understanding of delivery barriers and associated biology, and lead the search, evaluation, and assessment of relevant delivery technologies. This role offers the opportunity to shape strategy, develop and champion concepts, and assemble the data package to support translation into clinical development. The ideal candidate will also have strong writing and editorial skills to create peer-reviewed publications.
Responsibilities
The successful candidate will lead investigation of innovative device-based drug delivery solutions to improve tissue exposure when systemic delivery does not fully exploit the potential of our drugs. In close collaboration with partner functions in Discovery and Development Biological Sciences, the incumbent will develop a thorough understanding of delivery barriers and associated biology, and lead the search, evaluation, and assessment of relevant delivery technologies. This role offers the opportunity to shape strategy, develop and champion concepts, and assemble the data package to support translation into clinical development. The ideal candidate will also have strong writing and editorial skills to create peer-reviewed publications.
Responsibilities
- Supplier Due Diligence: Execute due diligence on potential device suppliers, emphasizing those with capabilities to facilitate pathways to clinical trials and commercial launches. Partner with medical device suppliers throughout early development stages.
- Preclinical Study Design: Collaborate in developing study protocols by providing expert insights to enhance device performance and achieve targeted endpoints effectively.
- Data Analysis and Presentation: Analyze and interpret data from preclinical studies, focusing on drug biodistribution, efficacy, and toxicity. Co-author presentations designed to assist stakeholders in making informed project milestone decisions.
- Publications: Co-author and co-edit white papers and external publications to share insights and findings with the broader scientific community.
- Ph.D. in Biomedical Engineering or M.D. in a specialized area of Neuroscience/Neuro-Oncology. 5 years of experience .
- Demonstrable experience with drug delivery to the Central Nervous System, including related surgical procedures and medical devices.
- Research Publication Skills: Proven ability to independently draft peer-reviewed papers.
- Strong skills in editing, reviewing, and revising manuscripts to ensure clarity and coherence.
- Excellent communication abilities for collaborating with co-authors and editorial board members.
