Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille Syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
The Associate Director, Clinical Quality Assurance is responsible for overseeing the clinical quality assurance function including developing and maintaining monitoring plans for assigned programs. Works in a collaborative manner with business partners to create a team environment that addresses compliance-related issues and corrective actions that meet the business needs on an on-going basis. This position will enhance the clinical quality and compliance culture at the firm to assure a continued state of inspection readiness. This is a fantastic opportunity to make an impact, wear many hats, and be a part of an exciting growing biotech company. This position is located in Foster City.
- Develops Quality Plans and oversees implementation of quality activities for assigned projects according to the agreed upon deliverables and established timelines.
- Employs systems and procedures to ensure that the generation, documentation, and reporting of data is in compliance with study protocols, systems design, GCP, and applicable regulatory requirements.
- Provides ongoing compliance support to clinical team, prepares periodic clinical trial quality metric reports for assigned programs and assesses these reports to identify areas of risk.
- Works in association with the Clinical teams to ensure phase 1 – phase 3 clinical trials are compliant with SOPs, FDA regulations, EMA directives and ICH/GCP guidelines.
- Performs & coordinates internal and external (both domestic and international) GCP related audits & ensures implementation of compliance systems to assure compliance with organization Standard Operating Procedures, FDA regulations, EMA Directives, ICH guidelines, and relevant local/regional regulatory standards.
- Performs and coordinates GCP related vendor audits to qualify their use in the conduct of clinical and non-clinical studies.
- Acts as a liaison between QA and other functional areas, collaborates with Trial Managers and others to assess audit/inspection observations for trends across protocol, program and/or processes, identifying root causes, and working with the appropriate colleagues to develop and implement CAPAs.
- BS or MS degree in clinical or scientific discipline preferred.
- Minimum 10 years of previous pharmaceutical industry experience, with at least 8 years of clinical development or quality assurance experience in the GCP area.
- Intimate knowledge of pharmaceutical industry GCP requirements, and related US and international laws; Ex-US experience is a plus.
- Experience in compliance auditing.
- Adept at problem finding / solving and organizational skills.
- Experience in training and implementing procedures compliant with FDA/EMA/ICH/WHO guidance or regulations.
- Knowledge of the overall drug development process.
- Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.
- Experience with regulatory submissions.
- Knowledge of/experience with quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset.
KNOWLEDGE, SKILLS & ABILITIES
- Adept in Microsoft Office applications (e.g., Word, Excel and PowerPoint).
- Excellent command of the English language demonstrated by both verbal and written communication skills.
- Ability to work in a dynamic organization with aggressive timelines.
- Strong interpersonal and problem-solving skills.
- Assertiveness, pro-activity, professionalism, and confidence.
- Ability to multi-task and handle pressure.
- Drive for excellence and self-motivated.
- Willingness to travel and to participate in some teleconferences during non-business hours.
- This is a high growth, fast paced small organization. The ability to be productive and successful in a work environment is critical.
Please submit your resume to firstname.lastname@example.org