Program Manager, Clinical Development

Director    ·     San Francisco Bay /Hybrid    ·    Full-time

About the job

We are seeking to hire an experienced and highly motivated Program Manager to work with our Clinical Development program teams. The successful candidate will have strong leadership skills in multidisciplinary teams’ settings with experience of clinical development including first in human (Ph1), proof of concept (Ph2) and pivotal / registrational trials (Ph3).

Responsibilities:

• Work in close collaboration with product / project leaders to develop and execute program strategies from IND through all phases of clinical development
• Develop timelines (Gantt charts) and integrated program plans for the tracking of product / project deliverables and task interdependencies
• Design and implement integrated multidisciplinary product / project plans to allow data driven decision making
• Drive problem solving, scenario-based development planning and strategy, and proactively identify and address programmatic gaps
• Proactively identify program risks and resource limitations allowing for the development of mitigation and contingency planning
• Lead the teams risk assessment at a program level. Plan and communicate risk management strategies to minimize program delays including risk acceptance, mitigation and contingency planning.
• Track progresses ensure clear goals and performance targets are in place, key milestones are met, proactively identify potential risks, create mitigation strategies where needed, and lead internal cross-functional progress updates.
• Present program team plans, annual budget and funding release to executive management groups at decision making forums.
• Facilitate program team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
• Champion and facilitate cross functional communication to align priorities for optimal program execution including stakeholder management and alignment with senior leadership company wide.
• Construct and track program budgets to align with organizational financial planning
• Responsible for R&D project management processes including annual program goal setting & quarterly reviews, prioritization of key program objectives, go/no-go decisions, data reviews based on key milestones
• Contribute to the evolution of program and portfolio best practices for improved processes and organizational efficiency

Background and skills:

• The ideal candidate will have prior experience in clinical development
• Bachelor’s degree required
• 8+ years industry experience, including minimum of 3-5 years with direct project management experience in biotechnology or pharma industries
• Demonstrated ability to manage and lead teams in clinical development programs
• Familiarity with the overall drug discovery and development process up to and including clinical trial initiation and execution (IND submission through Ph3 studies)
• Evidence of advanced problem-solving, innovative thinking, strategic planning to deliver creative solutions
• Ability to work collaboratively on multiple projects concurrently in a fast-paced environment
• Excellent organizational and analytical skills with a keen attention to detail
• Outstanding interpersonal skills to form and maintain strong relationships
• Willingness and dedication to go above and beyond in pursuit of team goals
• Experience with large and small molecule therapeutics approaches beneficial

Please click here to apply.