Senior Director, CMC Lead Product Development

Cytokineticsis 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.

Responsibilities :

• 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.

Qualifications:

• Ph.D. in Chemistry Pharmaceutical Sciences Engineering or related discipline with at least 10 years of development phase drug product drug substance and/or analytical science experience; M.S. with 15 years of relevant CMC experience required to effectively manage global teams and all CMC activities with respect to science technology quality regulatory/compliance requirements budget and resources.

• 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 well informed business decisions while balancing risk.
  • Experience across various asset modalities is desirable.
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Pay Range:

In the U.S. the hiring pay range for fully qualified candidates is $261000 - $304500 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidates geographic region job-related knowledge skills and experience among other factors.

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.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

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.

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Cytokinetics is an Equal Opportunity Employer

Required Experience:

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