Vice President/Senior Vice President, Clinical Development
19 days ago
Cambridge
Job DescriptionCompany 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 SummaryWe 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, • Lead the design and scientific oversight of clinical studies across multiple therapeutic areas and geographies, • Collaborate closely with VP of Clinical Operations to ensure study designs are operationally feasible and efficiently executed, • Establish relationships with key clinical investigators, academic centers, and patient advocacy groups, • Develop clinical protocols, informed consent documents, and study-related clinical materials, • Oversee medical monitoring activities and ensure rigorous patient safety oversight across all studies, • Provide direct oversight of the Pharmacovigilance function and team, • Ensure robust safety surveillance systems and processes are in place for all clinical and commercial activities, • Lead safety review and assessment of adverse events, including causality assessments and safety signal detection, • Oversee preparation of safety reports (DSURs, PSURs, IND safety reports) and safety sections of regulatory submissions, • Chair Data Safety Monitoring Board interactions and safety review committees, • Develop risk management strategies and safety communication plans, • Ensure compliance with global pharmacovigilance regulations and reporting requirements, • Work closely with project teams across the pipeline to design studies that efficiently answer key clinical and mechanistic questions, • Partner with VP of Regulatory Affairs to shape clinical strategies that support global registration pathways and lead regulatory interactions on clinical matters, • Collaborate with CMC and manufacturing teams to inform clinical supply requirements and specifications, • Coordinate with VP of Clinical Operations on site selection, investigator engagement, and operational execution strategies, • Serve as a key medical and scientific voice for Korro's clinical programs, partnering with executive leaders in external and internal communications, • Lead interactions with regulatory agencies (FDA, EMA, and other global authorities) on clinical development plans and safety matters, in partnership with VP of Regulatory Affairs, • Oversee clinical study reports and regulatory submission documents from a medical/scientific perspective, • Represent Korro's clinical programs at medical conferences and with external stakeholders, • Lead clinical publications strategy and contribute to scientific publications of clinical data, • Lead a lean clinical development team while demonstrating hands-on, strong, cross-functional leadership across the organization to drive clinical development objectives and outcomes, • Directly manage the Pharmacovigilance function and ensure appropriate staffing and capabilities, • Mentor 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 why, • Partner 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/PhD, • 12+ years of biopharmaceutical drug development experience with at least 8 years in clinical development leadership roles, • Proven record of accomplishment leading clinical programs from IND through Phase 2, ideally including proof-of-concept studies in metabolic, rare, or genetic diseases, • Experience with pharmacovigilance oversight and safety management in clinical development, • Experience with novel modalities (oligonucleotides, gene therapy, genetic medicines, or RNA-based therapeutics) strongly preferred, • History of successful regulatory interactions and IND submissions, • Deep understanding of clinical trial design, biostatistics, and regulatory requirements, • Strong knowledge of pharmacovigilance principles, safety surveillance, and adverse event management, • Familiarity with global pharmacovigilance regulations (FDA, EMA, ICH guidelines), • Experience across multiple therapeutic areas; familiarity with metabolic disorders, rare diseases, or liver diseases particularly valuable, • Knowledge of genetic medicine development, including biomarker strategies and patient identification approaches, • Understanding of pharmacokinetics, pharmacodynamics, and translational medicine principles, • Demonstrated ability to build, mentor, and retain high-performing team members, • Strong strategic thinking with ability to balance scientific and medical rigor with pragmatic development approaches, • Experience advancing multiple programs simultaneously with appropriate prioritization, • Proven ability to influence and collaborate across functions without direct reporting relationships, • Track record of delivering high-quality clinical programs that meet timelines and development objectives, • Outstanding scientific and medical communication skills, both written and verbal, • Ability to present complex clinical data to diverse audiences including regulatory agencies, investors, and scientific communities, • Collaborative leadership style with ability to partner effectively with Research, Preclinical, CMC, Clinical Operations and Regulatory Affairs, • Strong interpersonal skills and ability to build productive relationships with internal and external stakeholders, • Board certification in relevant medical specialty, • Experience with accelerated development pathways, breakthrough designations, or orphan drug programs, • Publication record in peer-reviewed journals, • Previous experience in biotechnology companies at similar stages of development, • Experience evaluating and integrating business development opportunities, • Prior experience in senior clinical leadership roles, • Experience 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.