Executive Medical Director, ATTR-PN, Clinical Development

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.
• 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 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.

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.
• Creativity, resourcefulness, high energy and flexibility.
• Excellent verbal and written communication skills.