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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Director, Clinical Quality

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