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    Director, Clinical Quality

    Alkeus Pharmaceuticals Inc
    5+ years
    Not Disclosed
    Cambridge
    10 July 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: GCP Quality Manager

    About Alkeus Pharmaceuticals:

    Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company focused on developing transformative therapies for severe, progressive eye diseases that can lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an investigational oral drug aimed at treating Stargardt disease (STGD) and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For more information, visit www.alkeuspharma.com.

    Responsibilities:

    • Oversee the GCP Quality functional area, ensuring compliance with US (FDA) and international regulations and guidance to protect the rights, safety, and welfare of clinical patients.
    • Provide quality oversight for internal and external clinical functions, ensuring adherence to GCP, GLP, regulatory standards (FDA, etc.), and industry best practices.
    • Serve as a Subject Matter Expert (SME) in GCP and GVP compliance for Clinical Operations, Pharmacovigilance, Data Management, and other clinical areas.
    • Assist in drafting and implementing Alkeus GCP/GVP Quality Management System SOPs.
    • Plan and execute audits of clinical sites and CRO/Vendors, including both external and internal GCP audits and gap assessments (on-site and remote).
    • Manage CAPA closure for audit observations from clinical sites, CROs, and internal audits.
    • Review clinical and data management operational plans, protocols, and key safety, clinical, and regulatory documents such as DSUR, IB, IND, and NDA.
    • Prepare for, host, and support Health Authority/Regulatory inspections and internal/external audits. Serve as an SME during regulatory inspections and support inspection Ready-Room activities.
    • Promote a culture of continuous improvement and cross-functional problem-solving.
    • Stay updated on industry developments, including forthcoming regulations and best practices.
    • Lead the development of internal and external Risk-Based Quality Assessments.
    • Advise on the severity and management of clinical protocol deviations.
    • Perform other duties as required, demonstrating flexibility and adaptability.

    Qualifications:

    • Bachelor’s or Master’s degree in a life science or healthcare field (e.g., Nursing) with 8-10 years of GCP experience in drug/biopharma companies or CROs.
    • Experience with small molecule drugs is a plus.
    • Ability to manage priorities independently while seeking guidance when necessary.
    • Strong knowledge of Quality Systems, GCP, and PV within FDA and EMA-regulated environments.
    • Proven ability to handle multiple assignments in a dynamic environment with changing priorities.
    • Excellent verbal and written communication skills, with the ability to collaborate effectively across functional areas in a start-up environment.
    • Ability to apply compliance and risk-based thinking to quality assessments and problem-solving.
    • Demonstrated capacity to influence change and drive process improvements internally and at clinical sites/CROs.
    • Experience in training and mentoring staff on industry best practices.

    Experience:

    • 7+ years of experience with Clinical Quality Systems in drug or biopharmaceutical fields.
    • At least 3 years of GCP auditing experience for clinical sites, CROs, and Pharmacovigilance, with the ability to conduct independent audits and deliver timely reports.
    • Experience in implementing and maintaining Clinical Quality Systems.
    • Proficiency in training staff on GCP and GLP principles and procedures.
    • Broad hands-on experience in GCP/GVP quality and regulatory compliance.
    • In-depth knowledge of FDA GCP/GVP Regulations and Guidance, ICH GCP/GVP Guidelines, EMA Directives and Regulations, and MHRA Regulations and Guidelines.
    • Thorough understanding of clinical drug development processes and auditing clinical study sites.
    • Experience assessing compliance for GCP/GVP databases, such as clinical data (EDC), PV, and eTMF systems.
    • Familiarity with drafting, quality checks, and source data verification for regulatory submissions is beneficial.
    • Experience monitoring clinical site data and with Small Molecule oral drugs is a plus.
    • Prior relevant experience at FDA (BIMO) as an investigator of Clinical Study Sites, Sponsors, GCP/GVP CROs, and Clinical Labs is advantageous.
    • Fluent in English, with proficiency in Microsoft applications (Excel, Word, SharePoint, PowerPoint).

    Travel:

    • Willingness to travel up to 20% as needed for CRO, Vendor, or Clinical Site audits.

    Apply today to join Alkeus Pharmaceuticals and contribute to advancing transformative therapies for eye diseases!

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