Clinical Trial Physician

Descriptions:

• 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)

- Part time (At least 2 Days a Week)

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