Position: Vendor & Budget Manager, Clinical Operations

Location: South San Francisco, CA

Opportunity:

Epicrispr Biotechnologies is seeking a Vendor and Budget Manager to join our growing Clinical Operations team. This role will play a critical part in overseeing vendor relationships, contracts, and budgets to support the successful execution of our clinical programs. This is a highly cross-functional role partnering closely with Clinical Operations, Finance, Legal, and external vendors to ensure studies are executed efficiently and in alignment with timelines, scope, and budget.

Roles and Responsibilities:

• Primary administrative point of contact for vendor coordination and communications, ensuring alignment with study priorities defined by Clinical Operations.
• Handle logistical setup of new vendors including coordinating contract reviews with internal stakeholders and legal and budget negotiation, in alignment with study scope and requirements defined by Clinical Operations.
• Manage all existing clinical vendors, requiring contract oversight and coordination with legal and internal teams, budget and PO oversight alongside internal finance and accounting, while partnering with the CTM and other Clinical Operations team members to ensure vendor deliverables align with study needs.
• Oversee site master budgets and ensure alignment with protocol updates, in coordination with CTM and Clin Ops priorities.
• Approve vendor invoices and budgets, including pass throughs from CRO, ensuring consistency with agreed scopes of work and escalation of discrepancies as needed.
• Support CMO, CTM, and Clinical Operations Lead with review of budget reporting from CRO alongside finance and accounting team.
• Track vendor performance, deliverables, contractual obligations, and escalate risks or delays to the Clinical Operations Lead.

Requirements:

• Bachelor’s degree in life sciences, business, or related field required
• Typically 5+ years of experience in clinical operations, vendor management, or clinical trial management within biotech, pharma, or CRO environments
• Strong understanding of clinical trial processes, vendor oversight, and GCP/ICH guidelines
• Experience managing contracts, budgets, and vendor relationships across multiple studies or programs
• Familiarity with CRO models, pass-through costs, and financial tracking processes
• Excellent organizational and project management skills with strong attention to detail
• Strong communication and stakeholder management skills, with the ability to work cross-functionally
• Ability to manage multiple priorities in a fast-paced, evolving environment
• Proficiency with clinical systems (e.g., CTMS, eTMF) and financial tracking tools preferred

Compensation: The salary range for this position is $135,000 to $145,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Position: Senior Clinical Research Associate

Location: South San Francisco, CA

Opportunity:
Epicrispr Bio is seeking a detail-oriented and proactive Senior Clinical Research Associate (CRA) to support the execution and oversight of clinical trials. This role will play a key part in ensuring studies are conducted in compliance with regulatory requirements, GCP guidelines, and company protocols, while maintaining the highest standards of quality and data integrity.

The ideal candidate will bring a strong foundation in clinical operations, experience working cross-functionally with CROs and clinical teams, and the ability to independently manage site activities while contributing to process improvements in a fast-paced, growing environment. This is an opportunity to have meaningful impact on clinical development programs while helping to build and scale operational excellence within the organization.

Roles and Responsibilities:

• Assist the Clinical Operations team with on-site sample operations, including sample receipt, registration, and shipments in a GCP environment.
• Support clinical trial manager with site management, including: site startup activities, co-monitoring visits alongside CRO, reviewing monitoring visit reports, coordinating vendor trainings, reviewing study newsletters, and other duties as needed, in alignment with study priorities and CTM guidance.
• Assist clinical trial manager with data verification and ICF reviews as needed, alongside CRO, to support data quality and protocol compliance.
• Partner with CTM and clinical team to help identify areas to improve our processes, with priorities defined by the CTM, and support implementation of agreed-upon improvements.
• Identify and communicate site-level issues, protocol deviations, and operational risks to the CTM to support timely resolution.
• Maintain study trackers, logs, and documentation across regulatory, site, data, and sample operations to support study oversight and execution.

Qualifications:

• Bachelor’s degree in life sciences or related field preferred
• 2 - 5+ years of CRA or clinical research experience (biotech, pharma, or CRO environment)
• Strong understanding of GCP, ICH guidelines, and clinical trial processes
• Experience working with CROs and managing clinical sites
• Excellent organizational, communication, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment

Compensation: The salary range for this position is $115,000 to $121,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Title: Research Associate II/Senior Research Associate, Process Development

Location: South San Francisco, CA

Opportunity:

Epicrispr Biotechnologies is seeking a highly motivated Senior Research Associate to join our Process Development team. This individual will contribute to the development and optimization of our in-house AAV platform, support preclinical vector supply, and play an active role in day-to-day lab operations. The ideal candidate is a hands-on experimentalist with strong experience in mammalian cell culture and viral vector production, who thrives in a fast-paced, collaborative startup environment. This role will support the development of scalable and robust processes to advance our gene regulation platform.

Roles and Responsibilities:

• Execute upstream AAV production (2-5L) using transient transfection in suspension cell culture, supporting iterative process improvements
• Conduct studies to develop representative scale-down models for manufacturing processes
• Contribute to DoE studies (shake flasks) and process characterization experiments to evaluate and define critical process parameters (CPPs) and assess their impact on critical quality attributes (CQAs)
• Support upstream production campaigns to meet preclinical material demands on schedule and within quality expectations
• Assist in generating and analyzing data sets to support process development reports, tech transfer documents, and internal presentations
• Perform and analyze dPCR and flow cytometry experiments
• Maintain thorough, accurate, and timely documentation of experimental methods, data, and results
• Support general lab operations including equipment maintenance, reagent and consumable inventory management, vendor coordination, and sample tracking
• Collaborate cross-functionally with Research, Analytical Development, and Manufacturing teams

Qualifications:

• B.S. degree in Cell Biology, Biochemistry, Biology, or a related discipline with 4+ years of relevant industry experience (or M.S. with 2+ years)
• Hands-on experience with mammalian cell culture (adherent and suspension), aseptic technique, and transient transfection
• Demonstrated proficiency in benchtop bioreactor AAV production (inoculation through clarification)
• Familiarity with AAV or viral vector production
• Experience with analytical methods such as PCR/dPCR and flow cytometry
• Solid data analysis skills with ability to interpret complex results, communicate findings, and recommend next steps
• Familiarity with statistical design and analysis, including Design of Experiments (DoE), is preferred
• Exceptional attention to detail with proven excellence in experimental documentation
• Strong critical thinking and creative problem-solving skills
• Self-motivated, proactive and takes initiative when managing multiple priorities
• Collaborative team player who communicates openly and effectively within department and cross-functionally
• Prior experience in a startup environment is a plus

Compensation: The salary range for this position is $80,000 to $108,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Title: Scientist I/ Scientist II, Bioanalytical
Location: South San Francisco, CA

Opportunity:
Epicrispr Biotechnologies is seeking a motivated Scientist I / Scientist II, Bioanalytical to support the development and execution of bioanalytical strategies across our pipeline. This individual will contribute to advancing preclinical and clinical programs through hands-on assay development, biomarker analysis, and data generation. The ideal candidate is detail-oriented, collaborative, and excited to grow in a fast-paced biotech environment.

Roles and Responsibilities:

• Design, develop, and execute bioanalytical assays to support preclinical and clinical studies, including PK/PD and biomarker assessments
• Perform routine and complex experiments, analyze data, and clearly document results
• Support development of cell-based potency assays for early-stage and clinical programs
• Troubleshoot assays and optimize methods to improve performance and reproducibility
• Maintain accurate and organized laboratory records and ensure data integrity
• Collaborate with cross-functional teams including R&D, Clinical Development, and Translational Sciences
• Coordinate with external CROs for sample analysis and timelines as needed
• Contribute to regulatory documentation by supporting bioanalytical sections of INDs and other filings
• Stay current with relevant technologies and apply new methods where appropriate
• Present findings in team meetings and contribute to scientific discussions
• Ensure compliance with GLP/GCP standards and internal quality systems

Qualifications:
• Scientist I:

• Ph.D. in Biology, Pharmacology, Bioanalytical Chemistry, or related field,
  or
• Master’s with 0–3+ years of relevant industry experience

• Scientist II:

• Ph.D. with 2–5 years of relevant industry experience,
  or
• Master’s with 4–7 years of relevant industry experience

Skills:

• Hands-on experience with bioanalytical assay development and/or execution
• Familiarity with techniques such as qPCR, digital PCR, ligand binding assays, LC-MS/MS, flow cytometry, and/or reporter gene assays
• Experience supporting gene therapy, cell therapy, or nucleic acid-based therapeutics is a plus
• Basic understanding of PK/PD principles and translational science
• Strong attention to detail and problem-solving skills
• Ability to work both independently and collaboratively in a team environment
• Effective communication and organizational skills
• Comfortable working in a fast-paced, evolving environment

Compensation: The salary range for this position is $124,000 to $148,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Title: Executive Assistant / Office Manager
Location: South San Francisco, CA

Opportunity:
Epicrispr Biotechnologies is seeking a highly organized, proactive, and strategic Executive Assistant / Office Manager to provide dedicated support to the CEO, CMO, and Senior Leadership Team. This role is critical in maximizing executive efficiency, ensuring seamless coordination of priorities, and serving as a trusted partner to leadership. The ideal candidate thrives in a fast-paced biotech environment and brings a high level of professionalism, discretion, and attention to detail.

Roles and Responsibilities:
• Provide high-level administrative support to the CEO, CMO, and Senior Leadership Team, managing complex calendars, prioritizing competing demands, and ensuring alignment with strategic objectives.
• Serve as a trusted partner to leadership, anticipating needs, proactively addressing challenges, and helping drive daily priorities and follow-ups.
• Coordinate and prepare for executive and leadership meetings, including agendas, briefing materials, and post-meeting action tracking.
• Manage domestic and international travel for executives, including detailed itineraries, meeting coordination, and real-time adjustments.
• Act as a primary liaison between executives and internal/external stakeholders, maintaining strong relationships and ensuring clear, timely communication.
• Prepare presentations, reports, and communications for board meetings, investors, and other senior stakeholders.
• Track and manage key projects and initiatives on behalf of executives, ensuring deadlines are met and priorities are progressing.
• Handle highly confidential and sensitive information with discretion and sound judgment.
• Assist with coordination of board meetings, investor communications, and executive-level events.
• Oversee light office management responsibilities, including vendor coordination, office supplies, and ensuring a well-functioning workplace environment.
• Partner with HR and Operations on onboarding logistics, office initiatives, and company-wide events.
• Identify opportunities to streamline processes and improve executive and organizational efficiency.

Qualifications:
• Bachelor’s degree preferred with 6+ years of experience supporting C-level executives or senior leadership, preferably within biotech, life sciences, or a fast-paced startup environment
• Proven ability to manage complex calendars, priorities, and executive workflows with a high level of autonomy
• Exceptional organizational, project management, and time management skills
• Strong written and verbal communication skills, with experience preparing executive-level materials
• High level of discretion, professionalism, and emotional intelligence
• Experience interacting with board members, investors, and senior stakeholders highly preferred
• Proficiency in Google Workspace, Microsoft Office, Slack, and calendar management tools
• Ability to thrive in a dynamic, fast-paced environment with shifting priorities

Compensation: The salary range for this position is $120,000 to $165,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Position: Scientist II/Senior Scientist Nonclinical Development

Location: South San Francisco, CA

Reports to: VP of Therapeutics

Job Summary

Position Overview:

Our company is seeking an experienced Nonclinical Development Scientist II/Senior Scientist with a deep understanding of gene therapy and regulatory agency requirements. The ideal candidate will have preclinical experience in the field of gene therapy and be able to lead the development of products from the research stage through to clinical trials. The role will involve working closely with cross-functional teams to ensure the successful development of gene therapy products that meet regulatory standards and effectively translate scientific discoveries into clinical practice. Reporting to the VP of Therapeutics, this role will deliver strategic and hands-on nonclinical development, working closely with Platform Development, Bioanalytical, and CMC teams.

What you will accomplish

• Design, oversee, perform and interpret in vivo nonclinical studies (non-GLP and GLP), including proof-of-concepts, pharmacology, biodistribution, and toxicology studies within established timelines.
• Manage CROs and external partners
• Write, review, and edit preclinical study reports and nonclinical sections of regulatory submissions
• Partner with platform development scientists to inform candidate selection strategy
• Develop PD biomarker strategy across programs and work closely with bioanalytical scientists to ensure efficient hands-off 
• Maintain up-to-date knowledge of regulatory guidance 
• Communicate effectively with Key Opinion Leader (KOLs) to maintain up to date understanding of the literature.
• Develop strategies for preclinical development, including the identification and management of risks and opportunities.

Qualifications

• Ph.D. or equivalent in medicinal chemistry, pharmacology, or related discipline, with a minimum of 5 years of related experience in biotechnology or pharmaceutical industry 
• Demonstrated experience working with regulatory agencies, including leading interactions with FDA, EMA, and/or other relevant agencies.
• Strong preclinical experience in gene therapy.
• Demonstrated ability to work with CRO and to collaborate with cross-functional teams and external partners, including regulatory agencies, academic institutions, and biotech companies.
• Bioanalytical experience is preferred

Technical Requirements and Skills: 

• Understanding of gene therapy and CRISPR based technologies.
• Strong communication skills, with the ability to effectively present scientific data and communicate complex scientific concepts to a wide range of stakeholders.
• Strong analytical and problem-solving skills, with the ability to effectively identify and address complex scientific and regulatory issues.
• Ability to work in a fast-paced environment, manage multiple projects, and meet deadlines.

Compensation: The salary range for this position is $130,000 to $160,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.