Obsidian Therapeutics, Inc
Associate Director, Clinical Quality
Obsidian Therapeutics, Inc, Cambridge, Massachusetts, us, 02140
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors.
We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our brand-new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
We are looking for a highly motivated
Associate Director, Clinical Quality
support advancement of our clinical trials in metastatic melanoma and non-small cell lung cancer. Reporting to the SVP Quality, you will be responsible for the development and execution of a GCP Clinical Quality Assurance program in order to ensure compliance with applicable ICH-GCP, GLP and applicable regulations. Key activities include conducting GCP audits, developing appropriate quality systems and providing guidance regarding applicable GCP requirements for the conduct of clinical studies.
You’ll be a vital part of a highly collaborative and mission-driven team working to deliver OBX-115 to patients and achieve Obsidian’s vision of translating innovative science into medical breakthroughs.
Define and implement a risk-based GCP quality management system as part of Obsidian’s overall Quality Management System
Develop an audit program and conduct internal and external GCP audits of clinical investigator sites and vendors, TMFs and laboratories to assess compliance, completeness and adherence to GCP and data integrity.
Manage the audit lifecycle activities such as scheduling, planning, issuing agendas, audit execution, issuing audit reports, evaluating responses and CAPA and audit closure
Present audit findings and/or other related audit information to appropriate departmental personnel, as required; escalates serious non-compliance issues to senior management
Work directly with auditees to ensure completion of corrective and preventative actions to address compliance concerns identified during audits
Identify non-compliance trends, gaps and implement mitigation strategies
Review study documents such as clinical protocols, IBs, ICFs and other documents to assess GCP compliance
Support investigation and closure of GCP related deviations/quality events/CAPAs
Collaborate with Clinical Operations, Technical Operations teams and CRO counterparts as needed, including participation in study team and QA meetings
Support Quality Management in inspection readiness activities and collaborate with study and functional area teams as needed; support the conduct of mock inspections and related activities; provide inspection preparation training to internal staff, clinical investigator sites, and vendors.
Lead and/or support strategic organizational quality and compliance process improvement initiatives
Other duties as assigned
Estimated travel: 20-30%.
Core Qualifications
Bachelor’s degree in a scientific discipline and 10+ years of relevant experience, including 5+ years in GCP Clinical Quality Assurance.
Oncology and cell and gene therapy experience ideal.
Experience independently conducting internal and external GCP audits (i.e., investigator site audits, process and vendor audits, etc.). GLP audit experience is a plus.
Excellent knowledge of ICH GCP and applicable CFR regulations with a working knowledge of GLP.
Experienced developing SOPs for risk-based quality management and quality by design for Phase I, II and III clinical trials.
A clear sense of ownership and accountability to meet commitments and high standards promoting the same with clinical sites, vendors, and labs.
Excellent planning, coordination, and time management skills.
Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.
Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization.
A track record of context-based sound judgement, including when to elevate risks and issues to leadership.
Prior experience in CRO is plus.
Systems thinking - You approach problem solving and process design with consideration of the overall system as well as its individual parts, considering interrelationships and patterns.
Obsidian is committed to equitable and transparent pay practices.
The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location.
Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.
Anticipated Base Salary Range $171,500 — $210,000 USD
Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
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We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our brand-new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
We are looking for a highly motivated
Associate Director, Clinical Quality
support advancement of our clinical trials in metastatic melanoma and non-small cell lung cancer. Reporting to the SVP Quality, you will be responsible for the development and execution of a GCP Clinical Quality Assurance program in order to ensure compliance with applicable ICH-GCP, GLP and applicable regulations. Key activities include conducting GCP audits, developing appropriate quality systems and providing guidance regarding applicable GCP requirements for the conduct of clinical studies.
You’ll be a vital part of a highly collaborative and mission-driven team working to deliver OBX-115 to patients and achieve Obsidian’s vision of translating innovative science into medical breakthroughs.
Define and implement a risk-based GCP quality management system as part of Obsidian’s overall Quality Management System
Develop an audit program and conduct internal and external GCP audits of clinical investigator sites and vendors, TMFs and laboratories to assess compliance, completeness and adherence to GCP and data integrity.
Manage the audit lifecycle activities such as scheduling, planning, issuing agendas, audit execution, issuing audit reports, evaluating responses and CAPA and audit closure
Present audit findings and/or other related audit information to appropriate departmental personnel, as required; escalates serious non-compliance issues to senior management
Work directly with auditees to ensure completion of corrective and preventative actions to address compliance concerns identified during audits
Identify non-compliance trends, gaps and implement mitigation strategies
Review study documents such as clinical protocols, IBs, ICFs and other documents to assess GCP compliance
Support investigation and closure of GCP related deviations/quality events/CAPAs
Collaborate with Clinical Operations, Technical Operations teams and CRO counterparts as needed, including participation in study team and QA meetings
Support Quality Management in inspection readiness activities and collaborate with study and functional area teams as needed; support the conduct of mock inspections and related activities; provide inspection preparation training to internal staff, clinical investigator sites, and vendors.
Lead and/or support strategic organizational quality and compliance process improvement initiatives
Other duties as assigned
Estimated travel: 20-30%.
Core Qualifications
Bachelor’s degree in a scientific discipline and 10+ years of relevant experience, including 5+ years in GCP Clinical Quality Assurance.
Oncology and cell and gene therapy experience ideal.
Experience independently conducting internal and external GCP audits (i.e., investigator site audits, process and vendor audits, etc.). GLP audit experience is a plus.
Excellent knowledge of ICH GCP and applicable CFR regulations with a working knowledge of GLP.
Experienced developing SOPs for risk-based quality management and quality by design for Phase I, II and III clinical trials.
A clear sense of ownership and accountability to meet commitments and high standards promoting the same with clinical sites, vendors, and labs.
Excellent planning, coordination, and time management skills.
Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.
Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization.
A track record of context-based sound judgement, including when to elevate risks and issues to leadership.
Prior experience in CRO is plus.
Systems thinking - You approach problem solving and process design with consideration of the overall system as well as its individual parts, considering interrelationships and patterns.
Obsidian is committed to equitable and transparent pay practices.
The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location.
Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.
Anticipated Base Salary Range $171,500 — $210,000 USD
Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
#J-18808-Ljbffr