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Senior Medical Director, Global Medical Affairs

Intellia Therapeutics, Inc.
over 2022 years ago
Remote friendly (Cambridge, MA)
United States
Medical Affairs

Role Summary

Senior Medical Director, Global Medical Affairs for lonvoguran ziclumeran (lonvo-z/NTLA-2002) hereditary angioedema. Lead the development and execution of a US and global Medical Affairs strategy to support the launch of lonvo-z. Bring clinical and pharmaceutical industry experience, ideally in immunology, allergy, or rare diseases, with strong hereditary angioedema expertise. Drive cross-functional alignment of medical and commercial goals and deliver real-world evidence and medical education to customers and payers.

Responsibilities

  • KOL Engagement Strategy (20%): Develop and drive a strategic engagement plan with key stakeholders including medical societies, payers, provider groups, and hereditary angioedema experts (US focus); build relationships with investigators, KOLs, research institutions, and centers of excellence to support HAE Medical Affairs objectives; collaborate with Patient Advocacy, Medical Engagement and Regional Scientific Directors to execute medical engagement strategy; plan and execute national and regional medical advisory boards; identify and prioritize thought leaders across geographies for global engagement topics.
  • Real-world Evidence Generation (30%): Collaborate with Clinical Development and HEOR to ensure the integrated evidence plan aligns with lonvo-z HAE objectives; provide medical support for design and execution of research and translational analyses, post-hoc analyses, post-marketing studies, real-world studies, and claims analyses; work with Access & HEOR to support educational, engagement and evidence initiatives; develop real-world evidence strategies including registry design and observational research; design and execute investigator-led research; provide medical input for health economic modeling and value proposition development; contribute to payer and policy maker evidence dossiers.
  • Internal Subject Matter Expert & Training Leadership (20%): Serve as primary in-house medical affairs SME on hereditary angioedema, CRISPR technology, and lonvo-z; oversee medical/legal review for commercial materials as needed (cMLR); deliver training programs for medical affairs, commercial, and market access teams; ensure medical accuracy and fair balance in educational materials for HCP audiences; contribute to scientific resources and competitive analyses; provide on-demand scientific consultation to cross-functional stakeholders; develop content and present at internal and external medical education programs.
  • Healthcare Systems Strategy (20%): Serve as in-house SME on lonvo-z systems obligations and competencies; contribute to cross-functional teams preparing for post-marketing accessibility, including prescriber and system readiness; design and execute an evidence generation plan to understand the impact of a one-time treatment on overall healthcare system costs with Access/HEOR collaboration.
  • Additional Responsibilities (10%): Support the Medical Affairs Lead for lonvo-z in short-term and long-term strategy and execution of the program medical affairs plan; participate in the Medical Access Commercialization team; collaborate with Scientific Communications on publications and resources to ensure medical accuracy and alignment; provide medical input into the safety profile in collaboration with Clinical Development and Patient Safety colleagues.

Qualifications

  • Robust clinical research experience within the pharmaceutical/biotech industry.
  • Experience within a medical affairs team with responsibility for late-stage clinical studies across multiple regions.
  • Strong track record in KOL engagement strategy development and execution.
  • Demonstrated experience leading and executing evidence generation initiatives.
  • Proven ability to serve as SME and deliver impactful training programs.
  • Solid communication, strategic, interpersonal, and negotiating skills; ability to proactively predict challenges and solve problems.
  • Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams.
  • Diplomacy and positive influencing abilities.
  • Knowledge of regional and global regulatory requirements.
  • Ability to present complex issues to management and contribute to executive-level presentations and discussions.
  • Experience leading and motivating cross-functional teams and vendors/consultants.
  • Excellent interpersonal skills with ability to respond to multiple external and internal queries and manage conflicts constructively.
  • Proven success working in a fast-paced, matrixed, growing organization, partnering with multiple internal and external stakeholders.
  • Experience in Medical Affairs leadership for products addressing rare diseases with strong therapeutic knowledge in hereditary angioedema, immunology, or related fields; familiarity with novel modalities (gene editing, CRISPR, genetic medicines) strongly preferred.
  • Track record of successful research in therapeutic areas relevant to Intellia's development programs and pipeline.

Education

  • MD/PharmD

Additional Requirements

  • Physical requirements: ability to sit or stand for multiple hours at a computer; manual dexterity for keyboarding.
  • Travel up to 40-50% for KOL meetings, conferences, and internal training sessions.