Executive Medical Director, Clinical Development

Intellia Therapeutics, Inc.•Cambridge, MA

3d•$368,946 - $450,934

About The Position

Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together. 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

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
MD

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.
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.
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.