СШАAssociate Medical Director / Medical Director
5 дн. назад
175k–250k USD / годСШАDirectorHybrid
Lead medical strategy and clinical development at a biopharmaceutical company developing genetic medicines using proprietary RNA editing technology.
О компании
- Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is for Urea Cycle Disorders. Korro is based in Cambridge, Massachusetts. For more information, visit .com. We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join u
Обязанности
- Serve as medical monitor for assigned studies, from first-in-human single and multiple ascending dose cohorts in healthy volunteers through early patient studies in urea cycle disorders and hepatic encephalopathy, including eligibility questions, medical review of protocol deviations, and ongoing review of safety and laboratory data.
- Lead medical assessment of adverse events, serious adverse events, and laboratory abnormalities, including causality, expectedness, dose-limiting toxicity determinations, and application of protocol stopping and dose modification rules, in partnership with Drug Safety and Pharmacovigilance.
- Serve on Safety Review Committees and support dose escalation and cohort progression decisions through integrated review of safety, pharmacokinetic, and pharmacodynamic data, including plasma ammonia and related biomarkers.
- Author and review clinical documents, including protocol concepts, protocols and amendments, informed consent forms, clinical sections of the Investigator’s Brochure, safety monitoring plans, and clinical study reports.
- Author clinical sections of regulatory submissions and health authority interactions, including INDs, CTAs, briefing documents, Development Safety Update Reports, and responses to health authority and ethics committee questions; prepare for and present clinical content at meetings with FDA, EMA, and other health authorities.
- Contribute to clinical development plans, target product profiles, and indication expansion strategy, including endpoint selection, patient population definition, and dose selection rationale for Phase 2 and pivotal study designs.
- Build and maintain relationships with investigators, key opinion leaders, and patient advocacy organizations in urea cycle disorders, hepatology, and alpha-1 antitrypsin deficiency; lead scientific advisory boards and investigator meetings; deliver protocol and medical training to sites and CRO staff.
- Partner with Clinical Operations, Biostatistics, Data Management, Clinical Pharmacology, Regulatory Affairs, Toxicology, and Drug Safety to deliver studies on plan, with medical input into case report form design, data review, interim and final analyses, and interpretation of results; provide medical oversight of CRO medical monitoring and safety services.
- Review and interpret emerging clinical data and present findings to program teams, executive leadership, scientific advisory boards, and external audiences; contribute to abstracts, presentations, and manuscripts.
- Maintain current knowledge of the scientific literature, treatment landscape, and competing programs in hyperammonemia, hepatology, and genetic medicines, and bring that knowledge into program decisions.
- Contribute medical assessment to portfolio and business development evaluations, including due diligence on external opportunities.
- At the Medical Director level, lead clinical strategy for an assigned program, represent Clinical Development in governance forums, lead health authority interactions for the program.
- Travel to investigational sites, investigator meetings, and scientific congresses, including international travel, up to 25%.
Требования
- MD or DO, or international equivalent, with completed residency training; board certification or eligibility in internal medicine, pediatrics, medical genetics, gastroenterology or hepatology, or a related specialty preferred.
- Industry clinical development experience in biotechnology or pharmaceutical companies: at least 2 years for Associate Medical Director; at least 5 years for Medical Director, including prior accountability as medical monitor on early-phase studies and authorship of protocols and regulatory documents.
- Direct experience with first-in-human and early-phase clinical trials, including dose escalation, safety review committees, and dose-limiting toxicity assessment.
- Clinical or development experience in rare disease, inborn errors of metabolism, hepatology, or genetic medicines strongly preferred; familiarity with urea cycle disorders, hyperammonemia, or hepatic encephalopathy a plus.
- Experience with oligonucleotide, siRNA, or other RNA-targeted therapeutics, including GalNAc-conjugated agents, a plus.
- Working knowledge of ICH GCP and of FDA and EMA requirements for early clinical development, including IND and CTA content; experience with early-phase studies outside the United States (for example Australia, Europe, or Asia) a plus.
- Strong scientific writing and data interpretation skills, with the ability to integrate safety, pharmacokinetic, and biomarker data and communicate conclusions clearly to scientific, operational, and executive audiences.
- Hands-on, collaborative working style suited to a small company, with the judgment to make and own medical decisions and the flexibility to work across multiple programs, sites, and time zones.
Другое
- Korro Bio is seeking an Associate Medical Director or Medical Director to provide medical leadership for our clinical programs, with initial focus on KRRO-121, our Phase 1 program for hyperammonemia in urea cycle disorders, and its potential expansion into hepatic encephalopathy. Reporting to the Vice President, Clinical Development, this physician will act as the medical lead and medical monitor for first-in-human and early patient studies, lead the clinical content of protocols and regulatory documents, and own medical judgment on dose escalation, safety review, and study design. Level will be set by depth of industry clinical development experience. The ideal candidate is a physician with early-phase development experience who is comfortable making and owning medical decisions in a small, fast-moving team and motivated to bring a new class of genetic medicines to patients.