The company is a compelling, fast-growing, clinical-stage biopharmaceutical company focused on transforming metabolic disorders through innovative therapeutics.
With expanding clinical development efforts, we are seeking an experienced Associate Director of Clinical Quality to join the team and help ensure the highest standards of quality across its clinical programs, reporting to the Head of Quality.
This will be a hybrid position, with a minimum of two days per week in the office in San Francisco, which is non negotiable. This position may require domestic and international travel up to 25%.
Position Summary
The Associate Director of Clinical Quality, under the direction of the Head of Clinical Quality, will be responsible for overseeing clinical quality activities across outsourced studies and internal operations to ensure patient safety and data integrity.
This role will manage GCP/GCLP/PV QA activities, including but not limited to :
- Procedures writing
- Clinical documentation review and issue resolution
- Management of quality documentation
- Audits and inspections
- Quality events, including deviations, CAPAs and investigations involving study misconduct/fraud
- Product complaints, conduct and oversee risk assessments
- Support cross-functional and GCP-specific asset transfers
- Compliance with GCP, GCLP, and PV standards
- Implementing new ICH E6 (R3) guidelines
The ideal candidate brings a strong background in GCP Clinical Quality (minimum 5 years' being directly responsible for Clinical Quality) and ideally has experience working within a small or start-up biotech environment. They must be comfortable operating in a dynamic, fast-paced and hands-on role. The ideal candidate has an energetic, engaging, and agile personality; we are looking for a quality-oriented, proactive achiever with high levels of integrity.
This person should have strong organizational and interpersonal skills, and the ability to build positive relationships with effective communication, influencing, conflict resolution, critical thinking, and problem-solving, and have the ability to work both independently and collaboratively to manage multiple tasks in a fast-paced, fluid working environment.
Key Responsibilities
- Manage clinical quality day-to-day activities, including oversight for outsourced activities to CROs and other vendors.
- Represent Clinical Quality in cross-functional teams
- Work closely with Clinical Operations, Clinical Development, Non-Clinical, IT, Regulatory Affairs, Pharmacovigilance, and Quality teams to identify, assess, and resolve clinical quality issues.
- Collaborate cross-functionally to promote a culture of quality and compliance within clinical development.
- Support the development, review, and approval of clinical documents (e.g., protocols, investigator brochures, study reports).
- Assist in the assessment and documentation of protocol deviations and ensure appropriate CAPAs are implemented.
- Develop and maintain clinical quality systems, processes, and documentation.
- Accountable for escalation of significant quality deficiencies.
- Assist with the execution of GCP, GCLP, and Pharmacovigilance audit programs.
- Support GCP inspections and audits from regulatory authorities and collaborators.
- Lead inspection readiness activities and support regulatory inspection hosting.
- Assist with regulatory submissions, as needed.
Qualifications
- Bachelor’s degree in life sciences or related field.
- 5+ years of experience focused completely within GCP Clinical Quality Assurance.
- Demonstrated knowledge of GCP, GCLP, and Pharmacovigilance regulations, clinical trial processes, and industry best practices is desired.
- Excellent communication and collaboration skills are desired.
- Excellent oral and written communication, collaboration, and auditing skills are desired.
- High attention to detail, excellent organisational skills, and the ability to work on multiple projects with tight deadlines are desired.
- Experience communicating with both domestic and international collaborators with an awareness of cultural diversity.
- Previous participation in regulatory agency inspections is preferred.
- Experience in small or start-up biotech environments is preferred.
If you are interested in having the opportunity to work with a passionate, innovative, and mission-driven team, and be emboldened to meaningfully impact this nimble, high-growth company, then this may be the opportunity for you!
Please note - the onsite requirement in San Francisco is non-negotiable, and we cannot support any costs for candidates wishing to relocate.
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