About Alkeus Pharmaceuticals:

Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com

Responsibilities:

• Manage the GCP Quality functional area, in compliance with US (FDA) and international regulations and Guidance, to ensure that the appropriate processes, systems and activities are in place to protect the rights, safety and welfare of clinical patients
• Provide quality oversight of internal and external clinical functions, ensuring that operations in the clinical functional areas are compliant with GCP, GLP, relevant Regulatory (FDA, etc.), and industry standards
• Act as a GCP Subject Matter Expert(SME) in GCP and GVP compliance on operations supporting clinical areas such as Clinical Operations, Pharmacovigilance, Data Management, etc.
• Support the drafting and implementation of the Alkeus GCP/GVP Quality Management System SOPs.
• Manage the planning and execution of clinical site and CRO/Vendor audits.
• Perform external and internal GCP audits and gap assessments (on-site and/or remote) on an as-need basis.
• Manage clinical site, CRO/Vendor, and internal CAPA closure for audit observations.
• Review of clinical and data management operational plans and protocols
• Review of key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA
• Participate in preparing for, hosting and supporting Health Authority/Regulatory inspections and internal/external audits.
• Serve as an SME for areas of responsibility during regulatory inspections, and directly lead and/or support inspection Ready-Room activities.
• Promote a culture of continuous improvement, and cross-functional problem-solving
• Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.
• Lead the development of internal and external Risk-Based Quality Assessments.
• Advise on the severity and processing of clinical protocol deviations
• Perform other duties as necessary, demonstrating flexibility and adaptability.

Qualifications:

• Bachelor’s or Master’s degree in a life science or healthcare field (Nursing, etc.) with 8 to10 years of GCP experience in drug and/or biopharma companies, or in a Contract Research Organization (CRO) capacity.
• Experience with small molecule drugs is a plus.
• Capacity to self-manage priorities and work independently while seeking guidance when necessary.
• Demonstrated knowledge of Quality Systems, GCP, and PV within an FDA and EMA-regulated environment. Able to handle multiple assignments in a fast-paced environment with changing priorities and to influence and work independently in a team environment.
• Strong verbal and written communication and collaboration skills, with the ability to work effectively across functional areas in a small, hands-on pharmaceutical start-up environment.
• Ability to apply compliancel and risk-based thinking to quality assessments and problem-solving.
• Ability to influence change and process improvements internally and at clinical sites/CROs
• Demonstrated ability to train and mentor others in industry best practices.

Experience:

• 7 years’ experience with Clinical Quality Systems in the drug or biopharmaceutical fields.
• At least 3 years of prior GCP auditing experience of clinical sites, CRO’s and Pharmacovigilance required, with the ability to audit independently, and deliver timely reports and assessments.
• Experience in implementation and maintenance of Clinical Quality Systems.
• Experience in training staff on GCP and GLP principles, processes and procedures.
• Broad hands-on experience in GCP/GVP quality and regulatory compliance.
• Excellent 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.
• Auditing clinical study sites.
• Assessing compliance status for GCP/GVP databases, such as for clinical data (EDC), PV, and eTMF systems.
• Supporting inspection-readiness and Health/Regulatory Authority Inspections.
• Supporting the drafting, quality checks, and source data verification of regulatory submissions is beneficial.
• Experience in monitoring clinical site data is a plus
• Prior experience 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 a plus
• Fluent in English, with proficiency in Microsoft applications (Excel, Word, SharePoint, PowerPoint).

Travel:

• Willingness to travel, up to 20%, on an as-need basis for performance of CRO, Vendor or Clinical Site audits