Clinical Trial Physician (part time position)

·       Provide clinical leadership and medical strategic input for deliverables in the assigned clinical trial

·       Authoring sections of clinical trial protocols, ICFs, IB, CSRs, regulatory documents, responses to ethic committees and health authorities

·       Medical review of trial data, trend identification, functions as study medical monitor

·       Supports program safety reporting (e.g., PSURs, DSURs, and safety related documents

·       Provide CRO oversight for medical functions

·       Conduct literature reviews and prepare summaries to support clinical development programs

·       Support Global Clinical Director with providing medical input CDP

·       Provide support in interactions with external partners (e.g., regulatory authorities, KOLs, data monitoring boards, AD Boards, patient advocacy groups), internal partners (e.g., Clinical Trial Team, commercial functions, pre-clinical and medical affairs)

Requirements:

·       MD (or equivalent medical degree) is required, neurologist or pain specialist

·       5+ years’ experience in clinical research/global drug development from the pharma/biotech across early and late development phases

·       3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrix environment

·       Expertise and experience in pain drug development, neuropathic pain/chronic pain (desirable)

·       Demonstrate ability to establish strong scientific partnership with key partners

·       Expert knowledge of GCP

·       Solid understanding of various clinical trial designs, statistical analysis methodology, trial operations and regulatory/ clinical development process

·       Excellent business communication and presentation skills

·       Strong interpersonal skills

·       Excellent negotiation and conflict resolution skills