Clinical Development Lead, Pulmovant

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👻 Score fantôme 23%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Pulmovant

Site WebLinkedInTous les Emplois

11 - 50 employés

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

Healthcare • Consulting • Food & Beverage

Pulmovant est une entreprise dédiée à transformer la vie des patients atteints de maladies pulmonaires en développant des thérapies innovantes. Leur produit phare, le mosliciguat, vise à offrir un traitement inhalé quotidien pour l'hypertension pulmonaire, se distinguant par son mécanisme novateur d'activation de la sGC. Avec un objectif unique de répondre aux besoins spécifiques des patients souffrant de pathologies pulmonaires, Pulmovant s'engage dans des essais cliniques approfondis pour faire progresser ses options de traitement pionnières.

Description

• Provide clinical and scientific input to study design, protocol concepts and development, statistical analysis plans, and reporting • Provide medical strategic oversight and accountability for study designs, protocol development, and regulatory documents with cross-functional teams • Lead execution and management of clinical studies, especially the Phase 3 trial, including study delivery, recruitment, site activation, data review and analysis, and reporting in compliance with GCP and regulatory standards • Monitor the therapeutic and regulatory landscape and provide guidance for program strategy • Collaborate with opinion leaders, Principal Investigators, internal clinicians, translational sciences, and clinical operations • Attend and present at investigator meetings and site initiation visits • Contribute to protocols, Clinical Study Reports, Annual Reports, safety reports, Health Authority pre-meeting packages, Investigator Brochures, and periodic clinical reports • Prepare abstracts, manuscripts, presentations, and clinical sections of regulatory documents • Maintain knowledge of ICH-GCP, external regulations, and procedures • Serve as primary medical accountability and oversight source, medical lead, liaison between investigators and internal study teams, and relationship manager for key opinion leaders and Health Authorities

🎯 Exigences

• MD/DO degree or equivalent is required • Minimum of 5–7 years’ experience conducting clinical research trials in the biopharmaceutical industry • Hands-on experience in protocol development and clinical trial monitoring • Strong written and verbal communication skills • Willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities • Ability to effectively give presentations at conferences, advisory meetings, and other public forums • Willingness to educate and mentor internal and external colleagues and collaborators • Strong ability to work within, lead, and motivate a cross-functional matrixed team • Scientific acumen and communication skills to influence and collaborate with scientific, regulatory, and business leaders • Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity • Ability to travel as needed • Board Certification or Board Eligibility in internal medicine with subspecialty training or experience in cardiopulmonary/respiratory medicine is highly desirable • Experience with late-phase clinical development is ideally desired • Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable