Medical Director, Clinical Development
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Job Description
Medical Director managing clinical development for CIDP at Dianthus Therapeutics. Leading trial oversight and collaboration across multiple teams in a remote setting.
Responsibilities:
- We are seeking a motivated physician to join the Clinical Development team for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
- The Medical Director MD, Clinical Development will report to the VP, Clinical Development, and will work in conjunction with the VP, Senior Medical Director and Clinical Scientist(s) to prepare, review and execute of clinical study protocols, data interpretation, and clinical study reports.
- You will act as the lead medical monitor with oversight of the CRO medical monitors and execution of the medical monitoring plan.
- In addition, you will collaborate with cross-functional teams to develop and review statistical analysis plans, informed consent forms, data listings, regulatory filings and responses to health authorities and ethics committees.
- In addition, in collaboration with clinical operations, you will help ensure timely recruitment and that investigative sites are following the principles of GCP.
- You will also work with the medical safety colleagues to ensure the safety of trial participants including interacting with the trial DSMB, reviewing ongoing data for potential safety trends, and evaluating cases of interest as they occur.
- The MD will also stay current on relevant medical and scientific trends by conducting literature searches and reviews, meta-analyses, and publishing data.
- This is an opportunity to join a growing organization with an expanding pipeline and drive clinical strategy for auto-immune neurology indications.
Requirements:
- MD with board certification in the US, with clinical experience in Neurology or executing neurology clinical trials preferred.
- Previous experience in industry-supported clinical research in the pharma/biotech/CRO setting with familiarity with clinical study documentation, processes, and execution preferred.
- Medical monitoring or pharmacovigilance experience.
- Strong ability to work collaboratively with cross-functional study teams, study vendors and clinical trial sites.
- Strong analytical and communication skills.
- Knowledge – thorough understanding of GCP/regulatory requirements
- Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision
- Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision
- Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable
- Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions.
Benefits:
- Remote work options
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