Representing CMC (DS, DP, Analytical) in applicable governance forums serving as spokesperson and advocate for the CMC team, ensuring transparent governance, bi-directional communication, cross functional ownership and proactive risk mitigation, for assigned programs.
Leads the cross functional CMC product development team meetings and ensures information flow between CMC and all respective program and portfolio governance forums as applicable.
Critically evaluates and integrates raw materials, drug substance and drug product inputs to development strategies and ensures alignment with overall corporate business objectives.
Will lead and manage one or more CMC project teams and contributes to project prioritization at a portfolio level, negotiating for additional resources when required, influences project timelines to ensure proper completion of required activities.
Serves as a mentor for functional representatives, provides feedback and input to their functional managers and identify growth needs for team members.
Leads development and execution of fully integrated product development strategy in support of clinical trials and regulatory approval.
Supports and contributes to the strategic direction of GSC&TO Program Management framework for asset development, including initiatives to drive continuous improvement of the CMC Development Roadmap and Governance and effectively collaborates across partner organizations.
Serves as CMC Lead on high profile partnerships and collaborations with other pharma/biotech companies and at the Joint Development Committee level driving joint decisions for the development programs.
Proactively communicates to GSC&TO/CMC and partner function senior leadership of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, and approvals during the development life cycle.
Leads and executes in alignment with ICH and applicable contemporary regulatory requirements.
Requirements
Critical experience/skillsets: Small molecule API, formulation development, and/or analytical development and product development from pre-clinical through to commercial.
Effective verbal communication at all levels throughout the organization.
Strong working knowledge of current technical regulatory requirements and trends (ICH, FDA, EMA, MHRA, at a minimum)
Demonstrated knowledge and experience with project and program management, governance, and risk management.
Negotiating, influencing, collaboration, and business acumen. Multiple product development experiences of leading a CMC team through IND and NDA/MAA preferred.
Must possess good scientific writing skills and good verbal skills.
Knowledge of pharmaceutical sciences, chemical development, analytical development, and the drug development process.
Must have CMC interdisciplinary experience and expertise within the oral solid, small molecule space.
Promotes enterprise thinking and makes
Additional Information
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
The Senior Director, CMC Lead is a unique opportunity to transform CMC product development into scalable process that enables a growing and complex portfolio. The Senior Director, CMC Lead will have overall strategic accountability for the product development strategy for assigned program(s) across the clinical development life-cycle and will serve as the single point of accountability for assigned CMC programs on cross functional forums across the enterprise. The Senior Director, CMC Lead is the strategic integrator between clinical research, clinical supply chain, CMC, quality, regulatory, program & portfolio management.
This role will include direct technical leadership on product development teams while supporting cross-functional teams that may include drug substance, drug product, and analytical subject matter experts; Clinical Development, Research & Non-clinical Development; Global Supply Chain & Technical Operations; Regulatory Affairs, Quality Assurance, and/or Program and Portfolio Management. Operating through influence rather than direct functional authority, success in this role requires trust and credibility, effective communication, subject matter expertise, a strategic mindset, and emotional maturity.
This position will be based at Cytokinetics' headquarters in South San Francisco, CA.
Cytokinetics · South San Francisco, CA