Vice President, Clinical Development

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $254 900 - $382 300 / an

⏰ Temps Plein

🔴 Expert

👔 Vice-président

🦅 Parrain de Visa H1B

info

🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Precision Medicine Group

Precision Medicine Group

1001 - 5000 employés

Fondée en 2012

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

💰 €35 200 000 Venture Round en 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group est un groupe mondial d’experts spécialisé dans la médecine de précision, qui combine sciences de laboratoire avancées, informatique translationnelle, affaires réglementaires, insights payeurs et communication marketing. L’entreprise se consacre à lever les défis de développement produit et de mise sur le marché pour des clients des secteurs pharmaceutique et des sciences de la vie. Ses services incluent une R&D orientée par les biomarqueurs, ainsi qu’un accompagnement à la commercialisation pour les organisations des sciences de la vie, du lancement jusqu’à la maturité du produit. Precision Medicine Group opère via deux pôles principaux : Precision for Medicine et Precision AQ, spécialisés respectivement dans les solutions cliniques et commerciales.

Description

• Reports to Chief Medical Officer, and across Precision for Medicine, supporting medical strategy. • Provides medical and strategic support for business development activities globally including client engagement, proposal support, client capabilities meetings, and professional meetings. • Provides strategic drug development consulting to autoimmune, rare and orphan disease clients. The consulting will be provided in the context of an integrated strategy with medical, clinical, regulatory, biostatistical, translational and marketing insights. • Create, review, or revise protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and investigational new drug applications. • Review laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed. • Participate and drive feasibility discussions relating to specific project proposals. • Develop training modules and conducts training for project teams and colleagues as necessary. • Ensure high quality, data driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conduct. • Propose strategies to manage and accelerate timelines for drug development strategies. • Ensures customer satisfaction by working closely with senior management, PFM operations, to provide optimum strategic consultancy to clients.

🎯 Exigences

• Successful completion of MD, MBBS, or equivalent training plus completion of training including a fellowship (Endocrinology, Rheumatology, Hematology-Oncology or other related field, board certification preferred, including European equivalents) • Experience in direct interactions with US and/or EU Regulatory Authorities • At least 10 years of senior leadership experience in the clinical research industry with a demonstrated knowledge and substantial experience including related disciplines (i.e. operations, medical monitoring, biostatistics, regulatory, preclinical, translational pharmacology, etc.) Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.

🏖️ Avantages

• health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation

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