Project Manager

🕒 il y a 16 jours

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

⏰ Temps Plein

🟢 Junior

🟡 Intermédiaire

👷‍♀️ Chef de Projet

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ICON plc

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1990

💊 Pharmaceutique

🧬 Biotechnologie

⚕️ Assurance santé

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc est un fournisseur mondial de services cliniques, de conseil et commerciaux à travers divers secteurs des industries de la santé et pharmaceutique. Ils offrent une vaste gamme de solutions cliniques, incluant des essais cliniques décentralisés, des solutions de sécurité cardiaque, des laboratoires cliniques précoces et de l'imagerie médicale. ICON fournit également des solutions technologiques qui soutiennent le développement de médicaments depuis les premières phases jusqu'à la post-commercialisation. Leur expertise thérapeutique couvre les domaines cardiovasculaire, oncologie, médecine interne et plus encore, avec un fort accent sur les thérapies transformatrices telles que les thérapies cellulaires et géniques ainsi que les biosimilaires. ICON est reconnu comme un leader dans le domaine de l'Organisation de Recherche Clinique (CRO), apportant régulièrement un leadership éclairé et contribuant à des publications et événements de l'industrie. Leurs services sont conçus pour optimiser les essais cliniques, offrir de l'intelligence réglementaire et fournir des preuves du monde réel à travers une analyse de données robuste et des solutions centrées sur le patient.

Description

• Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval • Ensure compliance with regulatory requirements and company Policies/SOPs • Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs • Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation • Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts) • Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders; with support as needed • Ensure alignment across PTA program decisions, documentation, plans, and implementation • Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products • Manage requests for investigational product access through PTA programs, ensuring timely and compliant processing • Manage vendor contracting and deliverables in support of PTA/continued access program execution • Utilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programs • Monitor quality, KPIs, and program performance; identify issues and escalate as needed • Communicate PTA program status, risks, and updates to stakeholders • Identify risks and implement mitigation strategies specific to investigational product access and program continuity; capture lessons learned and best practices • Ensure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programs • Support other PTA/continued access activities and programs, as assigned

🎯 Exigences

• BS/BA (or equivalent experience) • Experience in clinical research or biopharmaceutical operations; including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval; comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered • General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research • Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision • Proven experience collaborating effectively; influencing stakeholders across functions and levels • Evidence of strong project management skills; including managing competing priorities and solving operational challenges in clinical or investigational program environments • Successful history of working independently in a global environment • Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement.

🏖️ Avantages

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways