Senior Director, Clinical Development

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAlle Stellen

1 - 10 Mitarbeiter

Gegründet 2017

🧬 Biotechnologie

💊 Pharmazie

💰 €100.000.000 Private Equity Round im 2022-04

Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. ist ein biotechnologisches Unternehmen in der klinischen Phase, das sich auf die Entwicklung neuartiger monoklonaler Antikörper zur Behandlung schwerer Autoimmun- und Entzündungskrankheiten konzentriert. Das Unternehmen nutzt fortschrittliche Antikörpertechnologien, um die nächste Generation von Komplementtherapeutika mit verbesserter Selektivität und Potenz zu schaffen. Sein führendes Programm, DNTH103, ist ein monoklonaler Antikörper, der auf den klassischen Komplementweg für Erkrankungen wie generalisierte Myasthenia Gravis, multifokale motorische Neuropathie und chronische inflammatorische demyelinisierende Polyneuropathie abzielt. Mit Sitz in New York City und Waltham, Massachusetts, verfolgt Dianthus das Ziel, transformative medizinische Therapien zu liefern, indem es bisher ungedeckte Bedürfnisse in der Autoimmunbehandlung adressiert.

Beschreibung

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program. • Leading development of clinical sections of trial and program level regulatory documents. • Driving execution of the program and/or clinical trial in partnership. • Supporting the Vice President, Clinical Development by providing medical input into Clinical Development Plan (CDP) and Clinical Trial Protocol (CTP) reviews and contributing to/driving development of disease clinical standards for new disease areas. • Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process. • Leading the protocol development for the new selected indication/s, working closely with the relevant external and internal stakeholders. • As a medical specialist, supporting and leading interactions with external and internal partners and decision boards. • Medical monitoring of the assigned clinical trial/s, data and safety review and working closely with the clinical operations, and external partners to oversee conduct of the assigned clinical trial/s. • Working closely with the internal and external stakeholders as well as the clinical sites, and investigators to help ensure timely recruitment.

🎯 Anforderungen

• MD with board certification in 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. • 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.

🏖️ Vorteile

• Flexible work arrangements • Professional development