Regional Medical Affairs Manager

🕒 il y a 1 mois

🌽 Illinois – Distant

🌽 Illinois – Remote

💵 $190 000 - $210 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

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Photocure

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 1993

🧬 Biotechnologie

💊 Pharmaceutique

Biotechnology • Pharmaceuticals

Photocure est une société biopharmaceutique spécialisée, dédiée à améliorer la détection et la gestion du cancer de la vessie. L'entreprise développe et commercialise des solutions diagnostiques et thérapeutiques de précision, collabore avec des organisations de santé et de recherche, et soutient les preuves du monde réel, les registres de patients et les analyses médico-économiques pour faire progresser les soins en oncologie urologique à l'échelle mondiale.

Description

• Engage/build peer-to-peer relationships with national and regional key opinion leaders (KOLs) • Develop and participate in medical communication, education and training for KOLs • Identify data gaps related to disease area or products based on clinical insights • Participate in local and national congresses • Assist in the development, implementation, and delivery of Medical Advisory Boards • Leads or supports the design, planning, and execution of clinical projects, which may include interventional, observational, or post-marketing (e.g. Phase 4) studies • Provide input into study protocols, investigator brochures, statistical analysis plans, and clinical study reports • Drive study timelines, budgets, and milestones to ensure successful delivery • Lead site identification, feasibility assessments, and Site Initiation Visits (SIVs) • Support onboarding and training of investigators and study staff • Act as primary sponsor representative for CROs and vendors • Help manage vendor performance, timelines, and deliverables • Contribute to the management of sponsor studies, investigator-initiated studies (IIS/IITs), research collaborations from a scientific and operational perspective • Support ongoing registry programs with a focus on data quality and site performance • Contribute to medical communication and data dissemination • Contribute to publication strategy, including abstracts, manuscripts, and presentations at scientific congresses (e.g., AUA, EAU) • Collaborate with investigators to produce and support manuscripts • Keep internal stakeholders informed to ensure timely dissemination of clinical data • Align with Photocure Global Medical Affairs on numerous topics (e.g. publication communications)

🎯 Exigences

• Advanced degree (MD, DO, PharmD, PhD) in life sciences or related field • 5+ years of experience in medical affairs or clinical development • Experience in urology, oncology, or medical device/diagnostics strongly preferred • Experience with bladder cancer or cystoscopy technologies is desirable • Experience supporting regulatory submissions and publications a bonus • Ability to work cross-functionally in a fast-paced, evolving environment • Ability to work independently and execute tasks within deadlines • Knowledge of PhRMA, OIG and other guidelines relating to compliant medical communications • Demonstrated expertise in ability to synthesize and communicate medical information clearly. • Excellent oral and written communication skills • Ability to travel ~ 50% of time, or as needed, in US, Canada or Europe for KOL visits, SIVs, conferences, etc.