Medical/Senior Medical Director

Summary The Medical/Senior Medical Director will be responsible for contributing to and managing the strategy, design, execution and medical monitoring of clinical trials and clinical development plan design and implementation. Specific Responsibilities: Design and execute clinical development plans and protocols for clinical trials in food allergy Provide medical knowledge and support to study teams; participate in multidisciplinary meetings Contribute to the analysis and discussion of study results Author key clinical documents, including protocols, study reports, and regulatory filings Contribute to scientific publications Medical monitoring of clinical trials Supervise medical monitoring Work closely with Regulatory, CMC, and Clinical Operations counterparts Develop relationships with investigators and key opinion leaders Support interactions with the Scientific Advisory Board Participate in the evaluation of business development opportunities Qualifications / Requirements: Medical degreerequired - MD, MD/PhD, or PharmD Additional training/experience in allergy, asthma, or immunology preferred Have had "hands-on" patient care and clinical practice experience Clinical trialexperience either in the academic setting (as an investigator or sub-investigator) or in industry (as a medical director or medical monitor) Thorough understanding of GCP and familiarity with relevant FDA and ICH guidance Working knowledge of statistics as applied to clinical trial design and analysis Experience in writing and editing scientific research reports Experience working withCROs and other external resources preferred - company currently outsources clinical trials, but is planning to bring certain trial-related activities in-house Experience in filing a dossier to regulatory authorities Preferred Experience, Special Skills, Knowledge: Dedication to patient safety Collaborative and accessible Strong commitment to goals and timelines Ability to absorb new information quickly and gain command of relevant literature Preference for working in a fast-paced, team-oriented, environment Desire for new professional challenges Possessing excellent problem-solving & decision-making skills; strives for appropriate balance between taking initiative and seeking input from others Ability to analyze and summarize complex data and information concisely Excellent written and verbal communication skills, including fluency in English
Salary Range: NA
Minimum Qualification
Not Specified years

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