Korro Bio, Inc. · 5 hours ago
Vice President/Senior Vice President, Clinical Development
Cambridge, MA
Full-time
Onsite
Director/Executive
$390K/yr - $467K/yr
12+ years expKorro Bio, Inc. is a biopharmaceutical company focused on developing innovative genetic medicines using its proprietary RNA editing platform. The Vice President/Senior Vice President of Clinical Development will lead clinical strategy and oversee clinical trial execution for RNA editing therapeutics, ensuring seamless collaboration across various functions to advance multiple programs from preclinical development through clinical proof-of-concept.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
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
Drive data interpretation and clinical decision-making based on emerging trial results
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
Build and maintain pharmacovigilance infrastructure appropriate for stage of company growth
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
Provide clinical expertise to support preclinical program advancement and IND-enabling activities
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
Provide medical input to investor communications regarding clinical progress and strategy
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
Qualification
Required
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
Experience working in matrixed organizations and collaborating across functional boundaries
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
Strong medical/scientific judgment in evaluating benefit-risk profiles and making development decisions
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
Excellent problem-solving skills and ability to navigate complex scientific, operational, and safety challenges
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
Experience serving as medical/scientific spokesperson for clinical programs
Preferred
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 committees
Benefits
Medical
Dental
Vision
401(k) retirement plan
Life insurance
A dependent care flexible spending account
A Company-funded health savings account
Free parking
Company
Korro Bio, Inc.
Korro Bio was founded to turn extraordinary scientific insights into life-altering new treatments for patients.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$277.5MKey Investors
Deep Track CapitalEventideWu Capital
2024-04-18Post Ipo Equity· $70M
2023-11-06IPO
2022-01-05Series B· $116M
Leadership Team
Ram Aiyar
Chief Executive Officer
Todd Chappell
Chief Operating Officer
Recent News
Genetic Engineering News
2025-11-19
Company data provided by crunchbase