Consultant - Medical Affairs
Fremont, CA

JOB SPECIFICATION

The Position

Reports to Chief Medical Officer

Professional Responsibilities

• Support the Chair & the portfolio committee (composed of. Medical, Non clinical, discovery, regulatory, marketing and IP representatives)
• Define decision making criteria
• Liaise with discovery, non-clinical and regulatory to collect and assess said data in iterative process
• Perform comprehensive literature analysis and initial screening of potential indications
• Identify relevant Key Opinion Leaders (KOLs) in the various therapeutic fields
• Recruit KOLs and solicit initial advice
• Develop Medical Strategy and Select “Leading indication”
• Author draft protocol synopsis
• Participate in pre-IND Meeting with FDA and present/defend the protocol

Candidate Requirements

• M.D.; 3-5 years of work experience in a medical practice and 5+ years of scientific experience in a biotech or pharmaceutical setting in a development role (ideally in CMO capacity) overseeing clinical trials
• Knowledge of clinical development process and methods of scientific investigation, the FDA regulatory environment and guidelines, including study and protocol design
• Demonstrated proficiency in the implementation, monitoring, and management of clinical trials and the ability to interact in a cross functional environment
• Experience with clinical research publication activities, congress presentations, and public speaking.
• Candidate must demonstrate highly refined analytic and communication skills, both oral and written, and the ability to work effectively, both independently and in a team environment, including the ability to share and deliver information well
• Board certification in therapeutic area related to the position is desired.
• A personal network of key opinion leaders, teaching centers, and centers of clinical excellence preferred
• Must have the ability to drive to or fly to various meetings and clinical sites; some international travel may be required.