Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Medical Director - FSP
Job ID R0000044681Remote- US locations- East Coast preferred
Psychiatric/Neuropsychiatric experience required
Medical Director
This position will have critical responsibilities in the clinical department involved in the development of therapies for neuropsychiatric indications. Key trial related responsibilities include medical monitoring, review of eligibility forms, ongoing clinical data review, participation on protocol deviation teams, participation on cross-functional safety review teams, and participation on study teams and clinical subteams. This position will work cross-functionally to ensure projects trial issues and execution are well coordinated with partners from multiple departments:
•Serves as the Global Clinical Lead and medical monitor for 1 or more studies, including participation on the clinical subteams of those programs
•Direct authorship contributions in protocols, clinical study reports, study documents, regulatory documents, and external publications
•Provide medical review of clinical trial data and medical monitoring of clinical trials
•Interact with senior management in the context of data presentation, trial updates, and discussions of executional or strategic development issues
•Contribute to strategic discussions related to clinical development plans and indication prioritization
•In collaboration with clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met
•Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research programs and are compliant with clinical/medical and industry standards
•Critically review and contribute to regulatory documents and interactions as needed
Qualifications
•Requires an MD and residency training in psychiatry with extensive drug development experience in psychiatry, particularly clinical development (phase 1-3) experience in indications of schizophrenia, bipolar disorder, ADHD, major depressive disorder
•5 or more years of experience in the pharmaceutical industry in a clinical development role (medical director or senior medical director)
•Outstanding written and verbal communication, with experience interacting with and presenting to senior management and external audiences
•Ability to manage complexity and ambiguity in a highly matrixed work environment
•Displays strong leadership and collaborative interpersonal skills
•Ability to work independently, prioritize tasks efficiently, and meet expected time frames
•Ability to perform thorough reviews of various medical and trial related documents in a timely manner
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