
11 - 50 employees
Founded 2015
💊 Pharmaceuticals
🧬 Biotechnology
Pharmaceuticals • Biotechnology
Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline as a treatment for nicotine dependence (smoking and vaping cessation). The company is advancing cytisinicline through Phase 2 and Phase 3 ORCA trials and has submitted an NDA; its clinical program targets nicotinic receptors to reduce withdrawal and smoking satisfaction, with the goal of providing a new FDA-approved treatment option for tobacco and nicotine dependence.
🔥 13 hours ago
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11 - 50 employees
Founded 2015
💊 Pharmaceuticals
🧬 Biotechnology
Pharmaceuticals • Biotechnology
Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline as a treatment for nicotine dependence (smoking and vaping cessation). The company is advancing cytisinicline through Phase 2 and Phase 3 ORCA trials and has submitted an NDA; its clinical program targets nicotinic receptors to reduce withdrawal and smoking satisfaction, with the goal of providing a new FDA-approved treatment option for tobacco and nicotine dependence.
• 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
• 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
• 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
Apply Now🔥 13 hours ago
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