Senior Director, Scientific Affairs – Medical Education

🕒 il y a 10 jours

🇺🇸 États-Unis – Télétravail

💵 $290 000 - $310 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

🗣️🇺🇸🇬🇧 Anglais requis

D'où vient cette offre

Publiée sur la page carrières de Achieve Life Sciences, pas via un site d'emploi

Repérée par Remote Rocketship il y a 10 jours

Toujours ouverte sur le site de Achieve Life Sciences. Vérifiée il y a 3 heures.

Logo of Achieve Life Sciences

Achieve Life Sciences

11 - 50 employés

Fondée en 2015

💊 Pharmaceutique

🧬 Biotechnologie

Pharmaceuticals • Biotechnology

Achieve Life Sciences est une entreprise pharmaceutique spécialisée en phase avancée, axée sur le développement de la cytisinicline comme traitement de la dépendance à la nicotine (arrêt du tabac et du vapotage). L'entreprise fait progresser la cytisinicline à travers les essais ORCA de phase 2 et 3 et a soumis une NDA; son programme clinique cible les récepteurs nicotiniques pour réduire le sevrage et la satisfaction liée au tabagisme, avec pour objectif de fournir une nouvelle option de traitement approuvée par la FDA pour la dépendance au tabac et à la nicotine.

Description

• Lead Medical Affairs review within the Medical, Legal, and Regulatory process for promotional and non-promotional materials • Own scientific substantiation requirements, claims matrices, references, annotations, and alignment with approved prescribing information and the scientific platform • Develop MLR SOPs, review timelines, and reviewer training with Legal, Regulatory, and Compliance • Determine medical education materials, audiences, sequencing, and alignment with medical priorities • Establish strategy for residency curricula and education across priority medical specialties • Guide independent medical education grant strategy and review while maintaining ACCME compliance • Maintain consistent scientific positioning across the scientific platform and Clinical Council subdomain hubs • Serve as the formal Medical Affairs interface with Commercial leadership on cytisinicline scientific messaging • Develop and execute partnerships with specialty societies, continuing education platforms, EHR integration partners, quit lines, and public health organizations • Apply FDA requirements, the PhRMA Code, and pre-approval communication standards to medical strategy and materials • Report to the SVP, Medical Affairs, with a dotted line to the Chief Medical Officer • Travel up to 25% for conferences, medical education programs, company meetings, and other business needs

🎯 Exigences

• MD, PhD, PharmD, or another advanced scientific or clinical degree appropriate to the role • 10+ years of experience in Medical Affairs, medical communications, or agency-side medical strategy • Direct experience as an MLR medical reviewer • Deep working knowledge of FDA promotional requirements, scientific exchange, the PhRMA Code, and ACCME standards • Demonstrated success developing medical education strategies and multichannel scientific dissemination programs • Ability to balance commercial priorities with scientific rigor and communicate boundaries constructively • Strong cross-functional leadership and stakeholder management skills • Experience building processes and capabilities in a growing organization • Preferred: Experience supporting a pharmaceutical product launch • Preferred: Background in substance use disorder, addiction medicine, tobacco treatment, or a related therapeutic area • Candidates may reside anywhere in the continental United States

🏖️ Avantages

• Annual target bonus • Equity compensation • Medical insurance • Dental insurance • Vision insurance • 401(k)-retirement plan • Employee Stock Purchase Plan • Company-paid life insurance • Short- and long-term disability coverage • Paid time off • Paid company holidays • Remote work arrangement

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