Director, Formulations
Cytokinetics
August 17, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Primary Responsibilities:
- Lead formulation and process development activities for early- and late-stage clinical candidates, aligned with development timelines.
- Lead strategic planning for formulation development, identifying risks and mitigation strategies to enable progression to clinical/commercial stages.
- Oversee formulation and process development activities and provide technical oversight of clinical drug product manufacturing at CMOs (documentation, planning, scheduling, execution, and person-in-plant support when required).
- Provide coaching, mentorship, and development support (as applicable).
- Support employee performance management (goal setting, development planning, feedback) when serving in a people leadership capacity.
- Strengthen team capabilities through methodologies and best practices for experimental design, data interpretation, and decision-making.
- Apply formulation principles to solve complex product development challenges and enable robust, scalable processes.
- Identify, evaluate, and implement innovative formulation technologies.
- Provide subject matter expertise for global CMC regulatory strategies and cross-functional plans.
- Author/review pharmaceutical development and manufacturing sections for regulatory submissions.
- Design, execute, and analyze lab studies; prepare technical protocols/reports.
- Contribute to external scientific visibility via publications, presentations, and conferences.
- Partner with Legal/IP to support patent strategy.
- Build and maintain cross-functional collaborations (Chemical Development, Analytical Development, Quality, Regulatory, DMPK, etc.).
Qualifications:
- Ph.D./M.S. (or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field.
- 10+ years industry experience in formulation/process development for oral dosage forms; cGMP experience required.
- People leadership experience preferred.
- Expertise in enabling formulations to improve solubility/bioavailability of poorly soluble compounds.
- Hands-on formulation development and experience optimizing large-scale drug manufacturing.
- Strong CMC/Technical Operations, Quality, and Regulatory cross-functional collaboration.
- Working knowledge: HPLC, UV spectroscopy, dissolution testing, solid-state characterization.
- Proficiency authoring CMC/regulatory submission sections.
- Strong communication with senior leadership; leadership/coaching and interpersonal skills.
Application instructions:
- Please review the GDPR policy PRIOR to applying.
- Lead formulation and process development activities for early- and late-stage clinical candidates, aligned with development timelines.
- Lead strategic planning for formulation development, identifying risks and mitigation strategies to enable progression to clinical/commercial stages.
- Oversee formulation and process development activities and provide technical oversight of clinical drug product manufacturing at CMOs (documentation, planning, scheduling, execution, and person-in-plant support when required).
- Provide coaching, mentorship, and development support (as applicable).
- Support employee performance management (goal setting, development planning, feedback) when serving in a people leadership capacity.
- Strengthen team capabilities through methodologies and best practices for experimental design, data interpretation, and decision-making.
- Apply formulation principles to solve complex product development challenges and enable robust, scalable processes.
- Identify, evaluate, and implement innovative formulation technologies.
- Provide subject matter expertise for global CMC regulatory strategies and cross-functional plans.
- Author/review pharmaceutical development and manufacturing sections for regulatory submissions.
- Design, execute, and analyze lab studies; prepare technical protocols/reports.
- Contribute to external scientific visibility via publications, presentations, and conferences.
- Partner with Legal/IP to support patent strategy.
- Build and maintain cross-functional collaborations (Chemical Development, Analytical Development, Quality, Regulatory, DMPK, etc.).
Qualifications:
- Ph.D./M.S. (or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field.
- 10+ years industry experience in formulation/process development for oral dosage forms; cGMP experience required.
- People leadership experience preferred.
- Expertise in enabling formulations to improve solubility/bioavailability of poorly soluble compounds.
- Hands-on formulation development and experience optimizing large-scale drug manufacturing.
- Strong CMC/Technical Operations, Quality, and Regulatory cross-functional collaboration.
- Working knowledge: HPLC, UV spectroscopy, dissolution testing, solid-state characterization.
- Proficiency authoring CMC/regulatory submission sections.
- Strong communication with senior leadership; leadership/coaching and interpersonal skills.
Application instructions:
- Please review the GDPR policy PRIOR to applying.