Head of Regulatory CMC

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.

Cytokinetics is seeking an experienced Head of Regulatory CMC, who is a strategic thinker, strong leader and team player. The Head of Regulatory CMC will provide leadership, high level strategic and operational regulatory direction and mentorship on projects including, but not limited to CMC development strategies, CMC regulatory requirements for clinical studies and marketing approvals in domestic and global markets, CMC risk assessments, critical issue management and Health Authority interactions. The role serves as a key partner with the Technical Operations and Supply Chain organization and acts as an advisor to senior management in order to plan, evaluate and recommend CMC strategy. The Head of Regulatory CMC will interface with external regulatory authorities and business partners with regard to CMC development, registration and post approval strategies. The individual will also maintain awareness of the global regulatory environment and assess and communicate impact of changes on development programs and commercial products. This is an exciting opportunity to join an organization with a growing pipeline and play an integral role in the creation and implementation of regulatory CMC strategies from early development through marketing approval.

Responsibilities

• Lead the development and execution of regulatory CMC strategies from early development through marketing approval
• Provide strategic input and regulatory guidance to technical operations, supply chain and project teams on regulatory CMC questions. Proactively identify CMC issues and implements appropriate regulatory strategies to mitigate
• Communicate CMC regulatory strategy, key issues and remediation activities needed throughout project/product life cycle to management levels within the organization and other key stakeholders
• Build strong collaboration with internal stakeholders, including Regulatory Affairs, Quality, Technical Operations and Global Supply Chain
• Oversee the preparation of regulatory CMC documentation for inclusion in regulatory subissions including INDs, CTAs, annual reports, and marketing applications. Provide review and approval of Regulatory documents and submissions
• Lead the strategic development of responses to CMC related questions from FDA or foreign health authorities and works with functional groups to provide timely responses to regulatory authorities
• Oversee activities for meetings with FDA and other regulatory authorities, lead negotiations and interactions with regulatory authorities on CMC matters
• Interpret and communicate regulatory CMC expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) to execute program objectives in compliance with applicable regulations
• Mentor direct reports and ensures continuing professional development of the Regulatory CMC team
• Maintain current knowledge of regulations and guidelines (FDA, ICH and other as required) and keeps abreast of changes in the regulatory environment

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

• Seasoned regulatory professional with 15+ years of industry experience and extensive experience (at least 10 years) in regulatory CMC
• Extensive experience with small molecule drug development as well as in navigating late stage drug development and commercial stage programs
• Deep expertise and understanding of the CMC disciplines, technical development and manufacturing, quality and supply chain and experience working on CMC teams
• Experienced leader with management and direct reports
• Thorough understanding of regulatory/ICH requirements specific to CMC development of small molecules
• Direct experience leading regulatory submissions, review processes and Health Authority negotiations resulting in product approval
• Outstanding interpersonal and communication (written and verbal) skills
• Minimum of a Science based BS or MS. Advanced degree (MD, Ph