Senior Director, CMC Lead Product Development
Cytokinetics
8 days ago
Remote friendly (San Francisco Bay Area)
United States
Operations
Responsibilities:
- Represent CMC (DS, DP, Analytical) in governance forums; advocate for the CMC team; ensure transparent governance, bi-directional communication, cross-functional ownership, and proactive risk mitigation.
- Lead cross-functional CMC product development team meetings; ensure information flow between CMC and program/portfolio governance forums.
- Critically evaluate and integrate raw materials, drug substance, and drug product inputs into development strategies aligned with corporate objectives.
- Lead and manage one or more CMC project teams; contribute to portfolio prioritization; negotiate for resources; influence timelines to ensure required activities are completed.
- Mentor functional representatives; provide feedback to functional managers; identify team members’ growth needs.
- Lead and execute fully integrated product development strategy supporting clinical trials and regulatory approval.
- Support and contribute to the GSC&TO Program Management framework, including continuous improvement of the CMC Development Roadmap and Governance.
- Serve as CMC Lead for high-profile partnerships/collaborations and Joint Development Committee decision-making.
- Communicate plans and risks to senior leadership through regular updates and periodic reviews in support of global filings and approvals.
- Lead and execute in alignment with ICH and applicable regulatory requirements.
Qualifications:
- Ph.D. in Chemistry/Pharmaceutical Sciences/Engineering or related field with 10+ years of development (drug substance, drug product, and/or analytical); or M.S. with 15+ years of relevant CMC experience.
- Skills/experience: small molecule API and formulation/analytical development; effective verbal communication; strong knowledge of technical regulatory requirements/trends (ICH/FDA/EMA/MHRA); project/program management, governance, and risk management.
- Preferred/desired: experience leading a CMC team through IND and NDA/MAA; strong scientific writing; CMC interdisciplinary expertise in oral solid, small molecule space; enterprise thinking; experience across various modalities.
- Represent CMC (DS, DP, Analytical) in governance forums; advocate for the CMC team; ensure transparent governance, bi-directional communication, cross-functional ownership, and proactive risk mitigation.
- Lead cross-functional CMC product development team meetings; ensure information flow between CMC and program/portfolio governance forums.
- Critically evaluate and integrate raw materials, drug substance, and drug product inputs into development strategies aligned with corporate objectives.
- Lead and manage one or more CMC project teams; contribute to portfolio prioritization; negotiate for resources; influence timelines to ensure required activities are completed.
- Mentor functional representatives; provide feedback to functional managers; identify team members’ growth needs.
- Lead and execute fully integrated product development strategy supporting clinical trials and regulatory approval.
- Support and contribute to the GSC&TO Program Management framework, including continuous improvement of the CMC Development Roadmap and Governance.
- Serve as CMC Lead for high-profile partnerships/collaborations and Joint Development Committee decision-making.
- Communicate plans and risks to senior leadership through regular updates and periodic reviews in support of global filings and approvals.
- Lead and execute in alignment with ICH and applicable regulatory requirements.
Qualifications:
- Ph.D. in Chemistry/Pharmaceutical Sciences/Engineering or related field with 10+ years of development (drug substance, drug product, and/or analytical); or M.S. with 15+ years of relevant CMC experience.
- Skills/experience: small molecule API and formulation/analytical development; effective verbal communication; strong knowledge of technical regulatory requirements/trends (ICH/FDA/EMA/MHRA); project/program management, governance, and risk management.
- Preferred/desired: experience leading a CMC team through IND and NDA/MAA; strong scientific writing; CMC interdisciplinary expertise in oral solid, small molecule space; enterprise thinking; experience across various modalities.