Executive Director, Global Clinical Quality (Contract)
Apply NowCompany: ReCode Therapeutics
Location: Menlo Park, CA 94025
Description:
Who We Are:
ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode's lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.
Summary of Position:
The Executive Director, Global Clinical Quality (Contract) will report to the Senior Vice President, Quality and CMC Regulatory. You are a key leader on the Clinical Quality team responsible for leading the GCP/GLP/GVP (GCLVP) Clinical Quality Assurance Function and ensuring compliant standards of quality clinical research and related activities.
The leader will work closely with cross-functional teams to support clinical development and ensure the integrity and quality of clinical practices and data to deliver on ReCode's mission of powering the next wave of genetic medicines. You will have substantial experience establishing, implementing and maintaining robust and phase-appropriate GCP, GLP, GVP (GCVLP) systems, inspection readiness, and are an inspirational leader that energizes and motivates your peers.
Responsibilities:
Qualifications:
Salary Range: *250.00 - 325.00 per hour
*Please note that for remote positions, salary may be adjusted for cost of living
Benefits Offered for Full-Time Employees:
ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.
ReCode Therapeutics is an Equal Opportunity Employer.
ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode's lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.
Summary of Position:
The Executive Director, Global Clinical Quality (Contract) will report to the Senior Vice President, Quality and CMC Regulatory. You are a key leader on the Clinical Quality team responsible for leading the GCP/GLP/GVP (GCLVP) Clinical Quality Assurance Function and ensuring compliant standards of quality clinical research and related activities.
The leader will work closely with cross-functional teams to support clinical development and ensure the integrity and quality of clinical practices and data to deliver on ReCode's mission of powering the next wave of genetic medicines. You will have substantial experience establishing, implementing and maintaining robust and phase-appropriate GCP, GLP, GVP (GCVLP) systems, inspection readiness, and are an inspirational leader that energizes and motivates your peers.
Responsibilities:
- Lead GCLVP Quality: Provide Clinical Quality leadership in collaboration with the clinical core team.
- Compliance Oversight: Ensure all clinical trial activities comply with GCLVP guidelines, international regulations and applicable laws.
- Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCLVP requirements
- QMS System Development: Develop and implement global clinical quality systems (GCVLP) in accordance with ICH, FDA, EMA and global competent authority regulations and other relevant industry guidelines
- Audits and Inspections: Lead, plan, conduct, and/or participate in GCLVP internal/external audits, mock inspections and external inspections and follow up activities
- Training: Develop and deliver internal training programs GCLVP principles, regulations and best practices for the organization
- Risk Management: Collaborate with cross-functional teams to identify potential internal or external risks to GCLVP compliance and develop mitigation strategies to effectively address risks.
- Vendor Oversight: Evaluate and monitor the performance of third-party vendors, including CROs, to ensure compliance
- Continuous Improvement: Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCLVP related processes and procedures.
- Mentor: Mentor staff and organization for development and growth in topics of GCLVP.
Qualifications:
- Bachelor's degree in biological sciences or related field with minimum of 15 years' experience in pharmaceutical/biotech setting. Advanced degree is desirable.
- Demonstrated success in establishing and leading quality systems and risk management tools for early to late phase clinical trials.
- Substantial knowledge of worldwide GCP/GLP/GVP requirements, best practices and ability to apply concepts in a compliant manner.
- Experience in successfully leading/hosting US and international health authority GCP inspections/interactions.
- Exemplary interpersonal, verbal and written communication skills that foster a collaborative and positive work environment
- Exceptional and nimble organizational, prioritization and management proficiencies
- Ability to deliver in a fast-paced, small company environment and seamlessly adjust workload based upon changing priorities.
- Additional Certifications in Quality and/or Clinical GCP Compliance are highly desirable.
Salary Range: *250.00 - 325.00 per hour
*Please note that for remote positions, salary may be adjusted for cost of living
Benefits Offered for Full-Time Employees:
- No premium cost for employees - 100% subsidized by ReCode for full-time employees
- Company 401k contribution
- 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
- Mental health support for employees & their families
- FSA available, including a lifestyle spending account subsidized by company
- Employee discounts at hotspots
ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.
ReCode Therapeutics is an Equal Opportunity Employer.