Senior Medical Director

Emploi pas sur LinkedIn

🕒 il y a 6 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👨‍⚕️ Directeur Médical

👻 Score fantôme 53%

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.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

I-Mab Biopharma

Site WebLinkedInTous les Emplois

11 - 50 employés

Fondée en 2016

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

💰 €65 000 000 Post-IPO Equity - I-Mab Biopharma en 2025-07

Healthcare • Manufacturing • Biotechnology

I-Mab Biopharma est une entreprise mondiale de biotechnologie se concentrant sur la découverte, le développement et la commercialisation de thérapies biologiques innovantes pour accélérer l'accès des patients à de nouveaux médicaments. L'entreprise fait progresser un pipeline de produits de stade clinique en immuno-oncologie et autres biologiques thérapeutiques—tels que les anticorps bispécifiques et monoclonaux—à travers la R&D interne et des partenariats, tout en s'engageant dans les relations avec les investisseurs et les activités réglementaires pour soutenir le développement et la commercialisation.

Description

• Design study protocols and clinical development plans in collaboration with cross-functional teams both in the US and China, in oncology or autoimmune therapeutic areas. • Author key clinical sections of IB, IND submissions, regulatory briefing books, Annual Reports, CSR; prepare strategy presentations; present and discuss data with governance, external consultants, KOLs and within regulatory meetings in conjunction with members of the development team. • Create and/or review study documents/plans including monitoring plan, data management plan, safety review plan, etc. • Perform ongoing data reviews and assume leadership of safety review meetings. • Communicate internally and externally both orally and in writing on clinical trial design and results. • Analyze and synthesize clinical data for publication, conduct and evaluate clinical trials. • Proactively identify clinical development risks and propose risk mitigation solutions. • Supervise project team members in planning, conducting, and evaluating clinical trials. • Serve as medical monitor with significant responsibility for safety surveillance. • Collaborate with R&D function and senior management in assessing requirements for emerging products, including next generation candidates. • Identify, select, and train clinical research centers and investigators. • Oversee planning and management of investigator meetings, advisory boards and other scientific committees as required by the protocol (e.g. independent reviews, DSMB’s etc.). • Participate in the selection of sites, CROs, and vendors.

🎯 Exigences

• Medical Degree from an accredited Medical School required • 2-5 years of experience within a pharmaceutical company environment preferred. • Working knowledge of medical, scientific, and clinical research in the oncology and autoimmune therapeutic areas highly preferred. • Extensive direct knowledge of the clinical development process with the ability to understand concepts of various phases and principles of study design is required • Experience interacting with medical monitors, development operations and clinical investigators • Thorough understanding of ICH, GCP, and relevant regulatory requirements is required. • A thorough understanding of clinical research methodology including study design, protocol writing and CRF preparation is required as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA process acquired through direct industrial experience is required • Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area. • The ability to work with cross-functional teams in a matrix environment is a must • Strong organizational and time management skills; meticulous and detailed oriented • Self-motivated and able to work with limited supervision • Excellent interpersonal and communication skills • Proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Office Timeline/Project.

🏖️ Avantages

• Ability travel domestically/globally at relevant oncology medical meetings/conferences (i.e., ASCO, SITC, ASH, etc.) up to 15 - 20% of the time • Authorized to work in the United States without Visa sponsorship