Head of Medical Affairs

Intellia•Cambridge, MA

5d•Hybrid

About The Position

The Head of Medical Affairs, reporting to the EVP, Chief Medical Officer, will be accountable for building and leading a high-functioning and integrated Medical Affairs team. The successful candidate will partner closely with Program Team Leads, R&D and Commercial, responsible for medical affairs strategy and plan for Intellia’s growing portfolio of products and pipeline. This leadership position requires a highly motivated individual with experience in evidence generation, scientific communication, stakeholder engagement, and extensive experience in successful product launches. The Head of Medical Affairs will be responsible for continuing to build and ready medical capabilities and preparing the organization to support US commercialization activities and global Phase 3 Clinical Trials while establishing scientific credibility and medical trust with key stakeholders. The head is a contributing member of the Development Leadership Team and the MAC.

Requirements

Excellent written and verbal communication and interpersonal skills
Demonstrated reputation as a well-respected, dynamic team leader with effective people management skills and a proven track record of successful product launches
Demonstrated track record to bring strategic insight in development and execution of medical and/or scientific plans in support of product development and differentiation, addressing healthcare stakeholder requirements, and clinical practice patterns on the national and global level.
Demonstrated ability to understand current and evolving environmental and market access issues and capable of managing shifting priorities in a rapidly changing environment
Ability to think strategically, critically analyze and synthesize complicated data and scientific information
Excellent and demonstrated interpersonal skills; ability to understand and respond to competing priorities, manage and handle conflict constructively.
MD or PhD in relevant education
15+ years of medical affairs leadership experience, including hands-on experience in evidence generation, stakeholder engagement, including payer engagement, is required
Strong understanding of clinical trial design and global healthcare delivery systems.
Strong knowledge and application of ICH GCP, GxP, global regulations and good document management practices.

Nice To Haves

Prior experience in gene therapy, gene editing, rare diseases, or expertise in cardiology preferred but not required

Responsibilities

Build and lead a highly engaged and effective Medical Affairs team, driving medical affairs activities across global and regions, and serving as a player-coach as required
Continue to build, mentor, and manage medical affairs capabilities across key functional areas including Medical Strategy, Field Medical, Medical Information, Scientific Communication, Patient Advocacy, and Medical Operations.
Serve as a strategic partner to internal stakeholders from Program Teams, R&D to Commercial
Lead a cross-functional team to develop an integrated evidence generation strategy and ensure timely execution of Medical Affairs led studies, including post-approval observational studies, disease registries, and patient surveys
Lead cross-functional review & approval of investigator-initiated studies as well as local and/or regional medical affairs study proposals
Partner with R&D stakeholders to ensure medical input on development activities, such as input on patient reported outcome measures in registrational studies and timely communication of clinical data
Partner with Clinical Operations team to support company sponsored studies, including site selection, study initiation, trial enrollment, and in select cases, study closing
Collaborate with R&D and Commercial stakeholders to develop and implement an integrated stakeholder engagement strategy and plan; oversee engagement activities of stakeholders across global and regions
Lead cross-functional efforts to ensure strong medical and scientific presence at key congresses, delivering an effective scientific share of voice
Collaborate with stakeholders to develop and implement responsible early access strategy and plans
Partner closely with local and regional stakeholders to support payer engagement and patient access
Evaluate medical insights, stakeholder needs and evolving scientific information to inform business and portfolio priorities.
Guide medical communication activities, external scientific engagement, educational initiatives, and publication-related planning.
Recruits, interviews, hires, and trains leading roles for Medical Affairs functions.
Managed the functional leaders of the Medical Affairs organization.
Provides constructive and timely performance evaluations to my direct reports.
Invests in the development of Medical Affairs employees.
Handles discipline and termination of employees as needed.
Reviews, develops, and implements actions to improve opportunities identified in annual Engagement Survey.