Associate Director, Clinical Quality Assurance

About the job

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.

As the Associate Director, Clinical Quality Assurance (CQA), you are a key member of the Clinical Quality team maintaining representing Clinical QA in cross functional setting, and advising Cytokinetics Clinical Operations, Biometrics, Drug Safety and Pharmacovigilance teams on GCP matters. This role will liaise and interface with internal and external stakeholders to assess and support GCP compliance with local, ICH-GCP guidelines and applicable regulations to drive and maintain quality standards and regulatory compliance culture at Cytokinetics. The ideal candidate has a quality mindset in global clinical development and oversees quality activities including but not limited to representing CQA on clinical study teams, inspection readiness, internal and external audits with a proven ability to manage multiple complex projects. You will lead, execute and manage Clinical QA activities while being an advocate to drive quality and regulatory compliance culture at Cytokinetics. This position may be hired as a remote employee.

This is an excellent opportunity to help enhance quality culture while having a direct impact on our late and early-stage clinical trials that are the future of Cytokinetics growth!

Responsibilities

Responsibilities include Clinical Quality Assurance (CQA) lead to ensure Good Clinical Practice (GCP) compliance and the quality of all deliverables including:

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Qualifications

Salary pay range: $160,000 – $190,000. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Cytokinetics is an Equal Opportunity Employer