Duties/Responsibilities
- Partner with the PLT to develop global plans defining paths to approval and use for potential medicine(s) in ATTR-PN.
- Co-lead the CDST with Development Operations to develop BLA strategy for nex-z in ATTR-PN.
- Serve as medical expert for the study team and medical monitor for Phase 1β4 clinical trials (MD required due to program complexity, progressive indications, and patient comorbidities).
- Lead medical plans and decisions for assigned Intellia clinical development programs.
- Partner with cross-functional teams to develop clinical development plans toward approval/registration in applicable populations/indications.
- Partner with medical affairs, market access, and commercial teams to drive maximum value of products.
- Key clinical sub-team member to execute these plans.
- Develop/maintain relationships with academic investigators, pharmaceutical partners, KOLs, and patient advocacy groups.
- Provide medical information on existing/emerging data; partner with pharmacovigilance on safety.
- Support regulatory submissions by authoring clinical sections for INDs, NDAs, and related documents.
- Author manuscripts and collaborate to meet publication objectives.
- Advise pre-clinical teams on interpretation of data, biomarkers, target product profile, and early-phase trial planning.
- Participate in/lead clinical discussions and due diligence with potential business development partners.
- May serve as key clinical member at governance meetings.
Supervisory Responsibilities
- Recruit, interview, hire, and train clinical scientists or director-level roles.
- Provide constructive, timely performance evaluations.
- Handle discipline and termination per company policy.
Requirements
Skills/Abilities:
- Served as medical lead for drugs in development (multiple phases preferred).
- Experience across trial conduct (planning/start-up/execution/close out, reporting).
- Understanding of global regulatory processes; FDA/EMA interactions; BLA/NDA experience strongly preferred.
- Gene editing/therapy knowledge/experience strongly preferred; rare disease knowledge preferred.
- Understanding of drug development process.
- Top-level clinical/scientific expertise in relevant disease area.
- Professional demeanor; strong interpersonal skills.
- Ability to manage multiple tasks and meet deadlines; creativity/resourcefulness/high energy/flexibility.
- Excellent verbal and written communication.
Education/Certifications
- MD
Application instructions
- Applications are accepted on a rolling basis until the position is filled.