Director, Publications – Medical Information

Job not on LinkedIn

🕒 September 26

🇺🇸 United States – Remote

💵 $200k - $275k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

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Kardigan

51 - 200 employees

Founded 2023

🏥 Healthcare

💼 Consulting

🎖️ Defense

Healthcare • Consulting • Defense

Kardigan is a heart health company dedicated to reimagining cardiovascular medicine. The company is focused on making cardiovascular disease preventable and curable, actively developing multiple targeted treatments to improve patient outcomes. Kardigan utilizes a cutting-edge research platform and is led by an experienced team with a deep background in cardiovascular drug development. Their mission is to innovate and accelerate the creation of medicines that directly address the underlying causes of cardiovascular diseases, transitioning from traditional symptom management to functional cures.

📋 Description

• Co-lead development and execution of integrated publication strategies across all disease areas and development programs. • Drive alignment between publication plans and broader scientific communication objectives. • Manage publication agencies and external publication partners. • Support publication charters and strategic publication plans aligned with clinical development milestones, evidence generation strategies, and Medical Affairs objectives. • Identify publication opportunities across clinical, translational, biomarker, real-world evidence, implementation science, and disease-state education initiatives. • Oversee publication development from concept through submission and dissemination. • Partner with clinical development, biostatistics, regulatory affairs, safety, legal, and research teams throughout publication development. • Lead publication operations infrastructure, including tracking systems, dashboards, annual planning, metrics, budget tracking, and governance workflows. • Ensure adherence to ICMJE guidelines, GPP standards, authorship policies, Sunshine requirements, and publication compliance standards. • Establish inspection-ready documentation, SOPs, work instructions, and quality management processes. • Develop and maintain scientific narratives and communication platforms across disease states. • Ensure consistent scientific messaging across publications, congress activities, medical education, field medical resources, corporate communications, and investor communications. • Lead operational planning, governance, budget management, vendor oversight, and performance reporting across Scientific Communications. • Develop dashboards and KPIs for publication execution, medical information performance, content utilization, and dissemination effectiveness. • Establish scalable systems and technologies for publication management, medical information operations, knowledge management, and launch readiness. • Identify opportunities to leverage AI and digital solutions. • Build and operationalize Kardigan's Medical Information capabilities toward commercialization. • Lead development and maintenance of standard Medical Information response documents, scientific response letters, FAQs, content repositories, and scientific exchange materials. • Establish and improve inquiry intake, triage, escalation, and response processes. • Ensure pharmacovigilance reporting and adverse event identification compliance. • Analyze inquiry trends and generate insights for Medical Strategy, Evidence Generation, and Medical Education priorities. • Serve as a strategic thought partner to Medical Affairs leadership. • Collaborate with Clinical Development, Research, Regulatory Affairs, Field Medical, Patient Advocacy, Commercial Strategy, and External Affairs. • Contribute to integrated Medical Strategy Planning and evidence dissemination planning.

🎯 Requirements

• PhD, PharmD or equivalent advanced scientific degree. • Demonstrated leadership in publications strategy and execution. • Significant experience managing publication agencies and external vendors. • Strong understanding of publication guidelines, publication ethics, and scientific communications best practices. • Experience leading cross-functional teams in complex development-stage environments. • Exceptional scientific writing, communication, and presentation skills. • 10+ years of pharmaceutical, biotechnology, or medical communications experience preferred. • Cardiovascular disease experience preferred. • Experience supporting launch or pre-launch products preferred. • Medical Information leadership experience preferred. • CMPP certification preferred.

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