Job Description
Job Description
Company Summary : 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 Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts.
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 us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.
Position Summary
We are seeking an exceptional VP (or SVP) of Clinical Development to lead our clinical strategy and oversee clinical trial execution across a diverse pipeline of RNA editing therapeutics. This role will be instrumental in advancing multiple programs from preclinical development through clinical proof-of-concept and beyond, working at the forefront of a transformative new therapeutic modality. Reporting to the Chief Scientific Officer, this position will work in close partnership with the VP of Clinical Operations, VP of Regulatory Affairs and VP Research & Preclinical to ensure seamless execution of Korro's preclinical and clinical development strategy. This role will have direct oversight of the Pharmacovigilance function.
Key Responsibilities :
Strategic Leadership :
- Define and execute clinical development strategy across Korro's portfolio spanning metabolic diseases, rare diseases, autoimmune conditions, and neurological disorders
- Partner with research, regulatory, and clinical operations to shape program priorities and accelerate paths to proof-of-concept
- Lead clinical planning for novel RNA editing programs, establishing precedents for this emerging therapeutic class
- Contribute to business development activities, including evaluation of external opportunities and partnership discussions
Clinical Strategy & Study Design :
Lead the design and scientific oversight of clinical studies across multiple therapeutic areas and geographiesCollaborate closely with VP of Clinical Operations to ensure study designs are operationally feasible and efficiently executedEstablish relationships with key clinical investigators, academic centers, and patient advocacy groupsDevelop clinical protocols, informed consent documents, and study-related clinical materialsOversee medical monitoring activities and ensure rigorous patient safety oversight across all studiesDrive data interpretation and clinical decision-making based on emerging trial resultsSafety & Pharmacovigilance Leadership :
Provide direct oversight of the Pharmacovigilance function and teamEnsure robust safety surveillance systems and processes are in place for all clinical and commercial activitiesLead safety review and assessment of adverse events, including causality assessments and safety signal detectionOversee preparation of safety reports (DSURs, PSURs, IND safety reports) and safety sections of regulatory submissionsChair Data Safety Monitoring Board interactions and safety review committeesDevelop risk management strategies and safety communication plansEnsure compliance with global pharmacovigilance regulations and reporting requirementsBuild and maintain pharmacovigilance infrastructure appropriate for stage of company growthCross-Functional Collaboration :
Work closely with project teams across the pipeline to design studies that efficiently answer key clinical and mechanistic questionsPartner with VP of Regulatory Affairs to shape clinical strategies that support global registration pathways and lead regulatory interactions on clinical mattersCollaborate with CMC and manufacturing teams to inform clinical supply requirements and specificationsCoordinate with VP of Clinical Operations on site selection, investigator engagement, and operational execution strategiesProvide clinical expertise to support preclinical program advancement and IND-enabling activitiesMedical & Scientific Leadership :
Serve as a key medical and scientific voice for Korro's clinical programs, partnering with executive leaders in external and internal communicationsLead interactions with regulatory agencies (FDA, EMA, and other global authorities) on clinical development plans and safety matters, in partnership with VP of Regulatory AffairsOversee clinical study reports and regulatory submission documents from a medical / scientific perspectiveRepresent Korro's clinical programs at medical conferences and with external stakeholdersLead clinical publications strategy and contribute to scientific publications of clinical dataProvide medical input to investor communications regarding clinical progress and strategyTeam Leadership & Development :
Lead a lean clinical development team while demonstrating hands-on, strong, cross-functional leadership across the organization to drive clinical development objectives and outcomesDirectly manage the Pharmacovigilance function and ensure appropriate staffing and capabilitiesMentor and develop clinical and safety team members to build organizational capabilities and develop succession potential.Foster a culture of scientific rigor, patient-centricity, cross-functional collaboration, and sharing the whyPartner effectively with Clinical Operations and Regulatory teams to create an aligned, high-performing development organization that can work across the organization and outside of their functional siloes.Qualifications : Experience :
MD, MD / PhD12+ years of biopharmaceutical drug development experience with at least 8 years in clinical development leadership rolesProven record of accomplishment leading clinical programs from IND through Phase 2, ideally including proof-of-concept studies in metabolic, rare, or genetic diseasesExperience with pharmacovigilance oversight and safety management in clinical developmentExperience with novel modalities (oligonucleotides, gene therapy, genetic medicines, or RNA-based therapeutics) strongly preferredHistory of successful regulatory interactions and IND submissionsExperience working in matrixed organizations and collaborating across functional boundariesTechnical Expertise :
Deep understanding of clinical trial design, biostatistics, and regulatory requirementsStrong knowledge of pharmacovigilance principles, safety surveillance, and adverse event managementFamiliarity with global pharmacovigilance regulations (FDA, EMA, ICH guidelines)Experience across multiple therapeutic areas; familiarity with metabolic disorders, rare diseases, or liver diseases particularly valuableKnowledge of genetic medicine development, including biomarker strategies and patient identification approachesUnderstanding of pharmacokinetics, pharmacodynamics, and translational medicine principlesStrong medical / scientific judgment in evaluating benefit-risk profiles and making development decisionsLeadership & Strategic Skills :
Demonstrated ability to build, mentor, and retain high-performing team membersStrong strategic thinking with ability to balance scientific and medical rigor with pragmatic development approachesExperience advancing multiple programs simultaneously with appropriate prioritizationProven ability to influence and collaborate across functions without direct reporting relationshipsTrack record of delivering high-quality clinical programs that meet timelines and development objectivesExcellent problem-solving skills and ability to navigate complex scientific, operational, and safety challengesCommunication & Collaboration :
Outstanding scientific and medical communication skills, both written and verbalAbility to present complex clinical data to diverse audiences including regulatory agencies, investors, and scientific communitiesCollaborative leadership style with ability to partner effectively with Research, Preclinical, CMC, Clinical Operations and Regulatory AffairsStrong interpersonal skills and ability to build productive relationships with internal and external stakeholdersExperience serving as medical / scientific spokesperson for clinical programsPreferred Qualifications :
Board certification in relevant medical specialtyExperience with accelerated development pathways, breakthrough designations, or orphan drug programsPublication record in peer-reviewed journalsPrevious experience in biotechnology companies at similar stages of developmentExperience evaluating and integrating business development opportunitiesPrior experience in senior clinical leadership rolesExperience with Data Safety Monitoring Boards and independent safety committeesWhy Join Korro Bio :
Opportunity to be at the forefront of clinical innovation in the development of RNA- based therapeutics for both rare and highly prevalent diseases.Collaborative and entrepreneurial work environment where innovation and creativity are encouraged and valued.Competitive compensation package including salary, bonus, equity, and benefits.If you are enthusiastic about advancing the development of innovative RNA therapeuticsandthriveinadynamicandfast - pacedenvironment,weencourage you to apply for this exciting opportunity to join the Korro Bio team.Benefits : Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.