The Medical Lead will design, execute, and interpret clinical research for Intellia’s leading clinical programs.  You will be a member of the cross-functional core program leadership team (PLT) for Intellia’s nex-z PN program. Your primary responsibility is to provide medical input to the long-term strategy for these global development program.  You will co-lead the cross-functional clinical development strategy subteam (CDST) for these therapies where your dual responsibility is to direct team decisions related to the short-term and long-term clinical development and provide medical input to the subteam efforts.  In addition, you will work cross-functionally with medical affairs, market access and the commercial teams to drive maximum value of Intellia’s products.    As a physician, you will serve as a resource for medical input across a range of programs including research.

Duties/Responsibilities

• Partner with members of the PLT to develop global plans that define the path for each potential medicine to approval and use in appropriate populations and indications (ATTR-PN).
• Co-lead the CDST with your Development Operations partner to develop BLA strategy for nex-z in ATTR-PN. 
• Serve as the medical expert for the study team and medical monitor for phase 1-4 clinical trials, as applicable.  Given complexity of these programs as well as the progressive nature of these indications, along with significant patient comorbid conditions, an MD is required for this role.
• Lead medical plans and decisions for assigned Intellia clinical development programs. 
• Partner with members of the cross-functional team to develop clinical development plans that define the path for each program to approval and registration in applicable populations and indications.
• Partner with medical affairs, market access and the commercial teams to drive maximum value of Intellia’s products.
• Key member of clinical sub-team to execute these plans. 
• Develop and maintain relationships with academic investigators, pharmaceutical partners, KOL’s, and patient advocacy groups. 
• Provide medical information on existing and emerging data. In response to questions from internal and external stakeholders, and you will partner with pharmacovigilance to best understand the safety profile of compounds. 
• Contribute to activities in support of the company’s regulatory submissions, including authoring clinical sections for INDs, NDAs, and other related documents.
• Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
• Advise the pre-clinical project teams as development candidates are brought forward to interpret pre-clinical data, identify biomarkers, define a target product profile, and plan for early phase trials.
• Participate in or lead clinical discussions and due diligence with potential business development partners in academia and industry.
• May serve as a key clinical member at governance meetings.
  

Supervisory Responsibilities

• Recruits, interviews, hires, and trains clinical scientists or director level roles.
• Provides constructive and timely performance evaluations.
• Handles discipline and termination of employees in accordance with company policy.

Requirements

Skills/Abilities

• Served as medical lead for drugs in development; multiple phases preferred
• Experience in all aspects of trial conduct (planning/start-up/execution/close out, reporting)
• Understanding of global regulatory processes
• Participated in key regulatory interactions with the FDA, EMA or similar national agencies; BLA/NDA experience strongly preferred.
• Knowledge and experience in gene editing/therapy is strongly preferred
• Knowledge and experience in rare diseases is preferred
• Understanding of drug development process
• Top level clinical and scientific expertise in relevant disease area
• Professional demeanor & excellent interpersonal skills when dealing with external customers / internal colleagues
• Ability to manage multiple tasks and deal effectively with deadlines
• Creativity, resourcefulness, high energy and flexibility
• Excellent verbal and written communication skills

Education / Certifications

MD

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please .