What are the responsibilities and job description for the Senior Director, Clinical Development position at RBW Consulting?
A fast growing, well resourced clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency.
This is an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune diseases.
The Senior Medical Director, Clinical Development will have significant impact in the overall success of their best in class clinical trial for CIDP.
You will lead the preparation, review and execution 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.
You will work collaboratively to develop statistical analysis plans, informed consent forms, data listings, and lead the clinical development component of global 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 a lead role in interacting with the trial DSMB, reviewing ongoing data for potential safety trends, and evaluating cases of interest as they occur.
Experience
- MD with board certification in the US, with clinical experience in Neurology or executing neurology clinical trials preferred.
- Previous experience leading industry supported clinical research in the pharma / biotech / CRO setting with familiarity with clinical study documentation, processes, and execution preferred.
This is an opportunity to join a growing organization with an expanding pipeline and drive clinical strategy for auto-immune neurology indications. They are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives.
Please CLICK APPLY and forward an up to date resume.
