Vice President/Senior Vice President, Clinical Development

Korro Bio • Cambridge, MA

46d • $390,000 - $467,000

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

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 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
• Safety & Pharmacovigilance Leadership:
• 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
• Cross-Functional Collaboration:
• 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
• Medical & Scientific Leadership:
• 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
• Team 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 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees