[Hiring] Senior Director, Clinical Development @Dianthus Therapeutics

Role Description

The Senior Medical Director, Clinical Development will be the clinical and medical strategic lead of one or more clinical trials for DNTH212. Reporting to the SVP, Clinical Development, you will:

• Steer the preparation, review, and execution of clinical study synopses and protocols, investigator brochures, and clinical study reports.
• Review SAPs and TLF shells, guide the evaluation of emerging clinical trial data, oversee/guide the data interpretation and data mining.
• Ensure assigned studies are conducted according to GCPs and SOPs.
• Act as the medical monitor in close collaboration with the CRO medical and clinical monitors.
• Ensure timely recruitment in collaboration with clinical operations.
• Oversee/guide in conducting literature searches and reviews, meta-analyses, and publishing data.

You must have experience with Rare Diseases or Neurology within the biotechnology or pharmaceutical industries. This is a unique opportunity to join a growing organization with an expanding pipeline and lead 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.

Qualifications

• MD with board certification in the US, with clinical experience in Immunology or Rheumatology.
• 8+ years of previous experience in clinical research in the CRO/biotech/pharma setting preferred.
• Experience in rare diseases, neurology is highly preferred.
• Proven ability to work with cross-functional teams, study vendors, and clinical trial sites.
• Strong business communication skills, written and verbal, and comfortable with giving presentations internally and externally.
• Thorough understanding of GCP/regulatory requirements.
• Highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision.
• Ability to identify challenges and risks and implement appropriate actions with some supervision.
• Collaboration skills to coordinate activities of internal cross-functional study teams as well as external vendors.
• Open-mindedness to listen to ideas from others and seek guidance when applicable.

Requirements

• Experience in medical monitoring of assigned clinical trials.
• Ability to support and lead interactions with external and internal partners and decision boards.
• Experience in literature review, KOL interactions, and attending scientific meetings.
• Capability to present the clinical development plan to relevant internal stakeholders.
• Lead protocol development for new selected indications, working closely with relevant external and internal stakeholders.

Benefits

• Opportunity to work remotely.
• Join a growing organization with an expanding pipeline.
• Be part of a culture focused on elevating patient care.