Senior Medical Director, Global Medical Affairs

Intellia Therapeutics, Inc.•Cambridge, MA

4d•$295,965 - $361,735•Remote

About The Position

As the Medical Affairs Senior Medical Director for the lonvoguran ziclumeran (lonvo-z or NTLA-2002) hereditary angioedema program, you will embrace the challenge to create an innovative US and global Medical Affairs approach to support the launch of lonvo-z. This individual has a history of clinical and pharmaceutical industry experience, ideally in the fields of immunology, allergy, or rare diseases, with expertise in hereditary angioedema being strongly preferred. This role has four primary focus areas: KOL Engagement Strategy - Leading the development and execution of comprehensive thought leader engagement Real-world Evidence Generation - Partnering with HEOR on real-world evidence generation to develop and execute post-marketing integrated evidence plan Internal SME & Training - Serving as the in-house subject matter expert for educational initiatives Healthcare systems Strategy – Partnering with the commercial and access team on ensuring access and accessibility in the post-marketing setting The candidate will have strong experience in product launches, including proven ability to translate and appropriately align commercial and medical goals and objectives.

Requirements

Robust clinical research experience within the pharmaceutical/biotech industry
Previous 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, with 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 both regional and global Regulatory requirements
Demonstrated 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 an ability to respond to multiple external and internal queries, managing and handling conflict constructively
Success working in a fast paced, matrixed, growing organization, partnering with multiple internal & external stakeholders
MD/PharmD
At least 7-10 years experience in Medical Affairs and Clinical Development in the biotechnology/pharmaceutical industry
Experience in Medical Affairs leadership for products addressing rare diseases, with strong therapeutic area knowledge in hereditary angioedema, immunology, or related fields
Ability to sit or stand for multiple hours at a computer
Manual dexterity for keyboarding; may include repetitive movements

Nice To Haves

Experience 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

Responsibilities

Develop and drive strategic engagement plan with key stakeholders identified as strategic partners, including medical societies, payers, and provider groups as well as medical experts in hereditary angioedema, especially in the United States
Develop relationships and drive interactions with investigators, KOLs, research institutions, and centers of excellence to oversee and support the HAE Medical Affairs plan objectives
Work closely with Patient Advocacy, Medical Engagement and Regional Scientific Directors to develop and execute medical engagement strategy
Play an integral role in planning and executing national and regional medical advisory boards with the HAE community
Identify, map, and prioritize thought leaders across relevant geographies to engage as a global medical director strategic team, as well as identifying relevant thought leaders based on special interest topics such as research, special populations.
Collaborate with other line functions (Clinical Development, HEOR) to ensure that the integrated evidence generation plan is aligned with the lonvo-z HAE program objectives
Provide medical support to the design and execution of research / translational analyses, clinical trial post-hoc analyses, post-marketing studies, real-world studies, and claims analyses
Work closely with Access & HEOR to support key educational, engagement and evidence generation initiatives
Partner on the development of real-world evidence strategies, including registry design and observational research
Design and execute the investigator-led research program
Provide medical expertise to support health economic modeling and value proposition development
Contribute to evidence dossiers for payers and policy makers
Serve as the primary in-house medical affairs subject matter expert on hereditary angioedema, CRISPR technology, and lonvo-z, including completing medical/legal/review for commercial materials, as needed (cMLR committee)
Deliver training programs for medical affairs, commercial, and market access teams
Responsible for the medical accuracy and fair balance of medical information in educational and other medical communication and learning materials designed for an HCP audience
Contribute to scientific resources, including disease overviews, competitive landscape analyses, and clinical data summaries
Provide on-demand scientific consultation to cross-functional stakeholders
Develop content and present at internal and external medical education programs as needed
Serve as the primary in-house medical affairs subject matter expert on lonvo-z systems obligations and competencies
Contribute to a cross-functional team to prepare for post-marketing accessibility of lonvo-z, including prescriber and system readiness
Design and execute an evidence generation plan that enables an understanding of the impact of a one-time treatment on overall healthcare system costs and burden together with Access/HEOR
Support the Medical Affairs Lead for lonvo-z in the development of short-term and long-term strategy, as well as execution of the program medical affairs plan as a key component of the integrated brand plan
Participate in the Medical Access Commercialization team for HAE, together and in close partnership with the Medical Affairs Lead and Program Brand Lead
Collaborate with the Scientific Communications team supporting the review and approval of publications and resources ensuring medical accuracy and alignment of all communication materials
Provide medical input into the safety profile of the product in collaboration with Clinical Development and Patient Safety colleagues