Director, Publications & Medical Information

The successful candidate will help shape how scientific evidence generated across clinical development, translational research, medical affairs, real-world evidence, and health outcomes research is transformed into impactful publications, congress presentations, medical education, scientific exchange, and medical information resources.

Key Responsibilities

Publications Strategy & Planning

• 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 that align 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.

Publication Development & Governance

• 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 future publication tracking systems, publication dashboards, annual planning processes, publication metrics, budget tracking, and governance workflows.

• Ensure adherence to ICMJE guidelines, GPP standards, authorship policies, Sunshine requirements, and publication-related compliance standards.

• Establish inspection-ready documentation, SOPs, work instructions, and quality management processes supporting publication and medical information activities.

Scientific Narrative & Data Communications

• Partner with Medical Directors and Scientific Communications leadership to develop and maintain scientific narratives and communication platforms across disease states.

• Ensure consistent scientific messaging across publications, congress activities, medical education materials, field medical resources, corporate communications, and investor communications.

Scientific Communications Operations & Excellence

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

• Develop and maintain dashboards and KPIs to measure publication execution, medical information performance, scientific content utilization, and dissemination effectiveness.

• Establish scalable systems, processes, and technologies to support publication management, medical information operations, knowledge management, and launch readiness.

• Identify opportunities to leverage AI and digital solutions to improve efficiency, content development, and insight generation.

Medical Information Leadership

• Build and operationalize Kardigan 's Medical Information capabilities as the company advances toward commercialization.

• Lead development and maintenance of:

• Standard Medical Information response documents

• Scientific response letters

• Frequently Asked Questions (FAQs)

• Medical Information content repositories

• Scientific exchange materials

• Establish and continuously improve inquiry intake, triage, escalation, and response processes.

• Ensure compliance with pharmacovigilance reporting requirements and adverse event identification procedures.

• Analyze inquiry trends and generate insights that inform Medical Strategy, Evidence Generation, and Medical Education priorities.

Leadership & Cross-Functional Collaboration

• Serve as a strategic thought partner to Medical Affairs leadership.

• Collaborate extensively 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.

Qualifications

Required

• 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.

Preferred

• 10+ years of pharmaceutical, biotechnology, or medical communications experience preferred

• Cardiovascular disease experience

• Experience supporting launch or pre-launch products

• Medical Information leadership experience

• CMPP certification

Exact Compensation may vary based on skills, experience and location.

Pay range

$200,000—$275,000 USD

Originally posted on Himalayas

• Medical Communications Director
• Publication Director
• Medical Affairs Director
• Scientific Communications Director

Source: Himalayas