Director, Publications – Medical Information

This is a fully remote position, open to applicants in United States.

📋 Description

• Co-lead the creation and implementation of comprehensive publication strategies spanning all disease areas and development initiatives.

• Foster alignment between publication plans and overarching scientific communication goals.

• Oversee publication agencies and external publication collaborators.

• Assist in the formulation of publication charters and strategic publication plans that correspond with clinical development milestones, evidence generation strategies, and Medical Affairs objectives.

• Recognize publication opportunities in clinical, translational, biomarker, real-world evidence, implementation science, and disease-state education endeavors.

• Supervise publication development from initial concept through to submission and distribution.

• Collaborate with clinical development, biostatistics, regulatory affairs, safety, legal, and research teams throughout the publication process.

• Direct the publication operations infrastructure, which includes tracking systems, dashboards, annual planning, metrics, budget oversight, and governance workflows.

• Ensure compliance with ICMJE guidelines, GPP standards, authorship policies, Sunshine requirements, and publication compliance standards.

• Develop inspection-ready documentation, SOPs, work instructions, and quality management processes.

• Create and maintain scientific narratives and communication platforms across various disease states.

• Guarantee consistent scientific messaging throughout publications, congress activities, medical education, field medical resources, corporate communications, and investor relations.

• Lead operational planning, governance, budget oversight, vendor management, and performance reporting for Scientific Communications.

• Design 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 utilize AI and digital solutions.

• Develop and implement Kardigan's Medical Information capabilities in preparation for commercialization.

• Oversee the creation and maintenance of standard Medical Information response documents, scientific response letters, FAQs, content repositories, and scientific exchange materials.

• Enhance inquiry intake, triage, escalation, and response processes.

• Ensure compliance with pharmacovigilance reporting and adverse event identification.

• Analyze inquiry trends and provide insights for Medical Strategy, Evidence Generation, and Medical Education priorities.

• Act as a strategic advisor to Medical Affairs leadership.

• Collaborate with Clinical Development, Research, Regulatory Affairs, Field Medical, Patient Advocacy, Commercial Strategy, and External Affairs.

• Contribute to the planning of integrated Medical Strategy and evidence dissemination.

⛳️ Requirements

• PhD, PharmD, or a comparable advanced scientific degree.

• Proven leadership in formulating and executing publication strategies.

• Extensive experience managing publication agencies and external partners.

• Strong knowledge of publication guidelines, ethics, and best practices in scientific communications.

• Experience leading cross-functional teams in intricate development-stage settings.

• Outstanding scientific writing, communication, and presentation skills.

• Over 10 years of experience in pharmaceuticals, biotechnology, or medical communications is preferred.

• Experience in cardiovascular disease is preferred.

• Experience in supporting launch or pre-launch products is preferred.

• Leadership experience in Medical Information is preferred.

• CMPP certification is preferred.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Collaborative and innovative work environment.

• Access to cutting-edge technologies and resources.