Aktis Oncology
Director, Clinical Quality Assurance
Aktis Oncology, Boston, Massachusetts, us, 02298
Aktis Oncology is a biotechnology company pioneering the discovery and development of a new class of targeted alpha radiopharmaceuticals to treat a broad range of solid tumor cancers. Founded and incubated by MPM Capital, the company has developed proprietary platforms to generate tumor-targeting agents with ideal properties for alpha radiotherapy. Designed for high tumor penetration and long residence time, Aktis Oncology's molecules will quickly clear other areas of the body, thereby maximizing tumor retention while minimizing the side effects of treatment. This approach would enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes.
The Director, Clinical Quality Assurance, reporting directly to the Vice President of Quality Assurance, will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities to ensure quality assurance and compliance of Aktis-sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Aktis Standard Operating Procedures (SOPs), and current industry standards and practices. Activities will generally fall under the following areas: QA audit program, Aktis quality systems, and internal/clinical study team support. The Director, Clinical QA will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness with regards to all quality requirements, and regulatory standards while meeting continuous clinical supply and delivery expectations. The ideal candidate will be based in the Boston area with the ability to attend on site meetings at least every other month.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Work collaboratively with the internal Aktis Clinical Operations Team to ensure compliance standards are achieved. Manage the GCP Quality interface and support for all Project Teams. Identify and access compliance risk areas and develop and implement risk mitigation measures. Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines. Review and approve Clinical SOPs. Develop and Implement Clinical QA SOPs. Develop and implement detailed audit plans and yearly GCP audit schedules. Ensure the timely and effective follow up of all identified or assigned quality issues. Conduct QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested. Direct or perform CSR audits and other audits. Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans. Direct and/or deliver yearly GCP training for internal staff. Work closely with Clinical Development, Clinical Operations, Biostatistics, and other clinical functions/departments to ensure compliance readiness. Provide leadership in inspection preparedness to clinical sites and vendors for regulatory government agencies. Provide management reports on audit strategy, plans, and findings Support process improvement initiatives; lead continuous process improvements within Quality. Maintain required knowledge of applicable regulations, guidelines, and company standards and procedures. KNOWLEDGE, SKILLS, AND ABILITIES
Knowledge of Good Clinical Practice (GCP) FDA and EMA regulatory requirements applicable to Biologics therapy products. Very good scientific and medical/clinical expertise. Solid expertise in clinical development and methodologies of clinical studies. Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies. Demonstrated capability to challenge decisions and status quo with a risk-management approach. Ability to negotiate to ensure operational resources are available for continued clinical conduct. Fluency in written and spoken English. Very good teaching skills; demonstrated ability to assist and train others Solid understanding of GCP and ICH clinical requirements. Demonstrated ability to lead on-site corporate, external, or Health Authority inspections Excellent written/oral communication skills and interpersonal skills to build key networks and business relationships across all levels of the business. Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents. A self-starter and a team player who thrives in a fast-paced dynamic team environment. Ability to travel upon need both domestically and internationally is required. EDUCATION AND EXPERIENCE
Bachelor's Degree or advanced degree in a scientific discipline. Minimum of 10+ years' current work experience in the pharmaceutical industry with 5 years of Clinical Operations required. Demonstrated Quality Management System experience (GCP-specific QMS experience preferred). Demonstrated Issue Management and CAPA experience in a clinical environment. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. Strong leadership with demonstrated ability to interface with senior leaders and different levels of organization.
The Director, Clinical Quality Assurance, reporting directly to the Vice President of Quality Assurance, will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities to ensure quality assurance and compliance of Aktis-sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Aktis Standard Operating Procedures (SOPs), and current industry standards and practices. Activities will generally fall under the following areas: QA audit program, Aktis quality systems, and internal/clinical study team support. The Director, Clinical QA will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness with regards to all quality requirements, and regulatory standards while meeting continuous clinical supply and delivery expectations. The ideal candidate will be based in the Boston area with the ability to attend on site meetings at least every other month.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Work collaboratively with the internal Aktis Clinical Operations Team to ensure compliance standards are achieved. Manage the GCP Quality interface and support for all Project Teams. Identify and access compliance risk areas and develop and implement risk mitigation measures. Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines. Review and approve Clinical SOPs. Develop and Implement Clinical QA SOPs. Develop and implement detailed audit plans and yearly GCP audit schedules. Ensure the timely and effective follow up of all identified or assigned quality issues. Conduct QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested. Direct or perform CSR audits and other audits. Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans. Direct and/or deliver yearly GCP training for internal staff. Work closely with Clinical Development, Clinical Operations, Biostatistics, and other clinical functions/departments to ensure compliance readiness. Provide leadership in inspection preparedness to clinical sites and vendors for regulatory government agencies. Provide management reports on audit strategy, plans, and findings Support process improvement initiatives; lead continuous process improvements within Quality. Maintain required knowledge of applicable regulations, guidelines, and company standards and procedures. KNOWLEDGE, SKILLS, AND ABILITIES
Knowledge of Good Clinical Practice (GCP) FDA and EMA regulatory requirements applicable to Biologics therapy products. Very good scientific and medical/clinical expertise. Solid expertise in clinical development and methodologies of clinical studies. Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies. Demonstrated capability to challenge decisions and status quo with a risk-management approach. Ability to negotiate to ensure operational resources are available for continued clinical conduct. Fluency in written and spoken English. Very good teaching skills; demonstrated ability to assist and train others Solid understanding of GCP and ICH clinical requirements. Demonstrated ability to lead on-site corporate, external, or Health Authority inspections Excellent written/oral communication skills and interpersonal skills to build key networks and business relationships across all levels of the business. Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents. A self-starter and a team player who thrives in a fast-paced dynamic team environment. Ability to travel upon need both domestically and internationally is required. EDUCATION AND EXPERIENCE
Bachelor's Degree or advanced degree in a scientific discipline. Minimum of 10+ years' current work experience in the pharmaceutical industry with 5 years of Clinical Operations required. Demonstrated Quality Management System experience (GCP-specific QMS experience preferred). Demonstrated Issue Management and CAPA experience in a clinical environment. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. Strong leadership with demonstrated ability to interface with senior leaders and different levels of organization.