Senior Director, CMC Lead Product Development
$261k - $304.5kCytokinetics
Cytokinetics seeks a Senior Director to lead Chemistry, Manufacturing, and Controls product development strategy across its cardiovascular drug pipeline. The role requires strategic oversight of CMC programs through clinical development, serving as a cross-functional integrator between research, supply chain, regulatory, and quality teams.
Responsibilities
- Represent CMC function in governance forums as spokesperson and advocate for assigned programs
- Lead cross-functional CMC product development team meetings and manage information flow across governance structures
- Develop and execute integrated product development strategy supporting clinical trials and regulatory approvals
- Mentor functional representatives and provide feedback to support team growth and development
- Serve as CMC lead for high-profile partnerships and joint development committee discussions
Requirements
- Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or related field with 10+ years CMC experience, or M.S. with 15+ years
- Small molecule API, formulation, and analytical development experience from preclinical through commercial phases
- Demonstrated knowledge of ICH, FDA, EMA, and MHRA regulatory requirements and trends
- Project and program management expertise with governance and risk management experience
- Strong negotiation, influencing, and collaboration skills with business acumen
- Leadership experience advancing CMC teams through IND and NDA/MAA submissions
- Oral solid, small molecule CMC interdisciplinary expertise
Compensation: $261,000 - $304,500 per year
Vacancy posted 25 days ago
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