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About the role
Key responsibilities & impact- 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
What you’ll need- 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.