Medical Director, ATTR-CM

Responsibilities

• Partner with members of the CDST, as needed, to develop global plans that define the path for each potential medicine to approval and use in appropriate populations and indications.
• Serve as the medical expert for the study team and medical monitor for phase 1-4 clinical trials, as applicable. Given complexity of the disease, its progressive nature in patients with significant comorbid conditions, an MD is required.
• Assist in the development of 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.
• 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, BLAs, 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.
• 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.
• About You:
• 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, training and experience in cardiology 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
• At least 5 years in industry, with the majority in key clinical development role
• #LI-Remote

Benefits

Additional Information

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. How You Will Achieve More: The Medical Lead will serve as a medical monitor for Intellia's nex-z ATTR-CM Phase 3 clinical trial. You will be an integral member of the cross-functional clinical development strategy subteam (CDST) for Intellia's nex-z ATTR-CM program and provide medical input to the subteam efforts. As part of this role, you will support medical monitoring work for Intellia's Phase 3 CM clinical trial, a complex cardiovascular outcome study in patients with progressive cardiac and neurological disease with significant comorbid conditions. In addition, as a physician, you will serve as a resource for medical input across a range of programs including research.

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