Job Description
About Us
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
We are seeking a motivated physician to join the Clinical Development team for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This position is designed for individuals looking to build a strong foundation in clinical development within a collaborative environment.
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. We 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. We are open to you working remotely.
Key Responsibilities
- Medical monitoring of the assigned clinical trial/s, data and safety review and working closely with the clinical operations, safety physicians, CRO medical monitors, and other external partners to oversee conduct of the assigned clinical trial/s
- Review safety data, adverse events, and protocol deviations in collaborations with cross-functional teams.
- Provide medical input to study teams, investigators and CRO partners.
- Supporting the design and execution of clinical trials, including protocol development and study oversight.
- Literature review, attending scientific meetings, advisory boards, and investigator meetings, and presenting the protocol to relevant internal and external stakeholders.
- Contribute to regulatory documents and ethics committees, as appropriate.
Experience
- 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
