Program Manager

Redbock - an NES Fircroft company; Brisbane (CA); On-site; USD 150,000 - 230,000; Full time

Job summary

Redbock - an NES Fircroft company seeks a Drug Development Program Manager to support early-stage IND/CTA preparation and late-stage regulatory submissions, partnering with Global Program Leads and cross-functional teams to drive Integrated Development Plans (IDPs) across the lifecycle.

You will develop IDPs, manage timelines and milestones, and lead planning across Clinical Development, Regulatory, Biometrics, CMC, Safety, and Nonclinical functions to ensure readiness for regulatory milestones.

Qualifications

• Bachelor's degree required.
• 8-10+ years in pharmaceutical/biotech drug development.
• Experience supporting development programs from IND-enabling activities through clinical development.
• Strong understanding of drug development lifecycle (clinical, regulatory, nonclinical, CMC).
• Experience leading complex cross-functional development programs in matrixed settings.
• Excellent communication, presentation, and executive-facing skills.
• Onsite work 2-3 days per week (50%) in Princeton, NJ, Cambridge, MA, or Brisbane, CA (non-negotiable).

Responsibilities

• Partner with GPLs, GPMs, Clinical Science, and cross-functional stakeholders to develop and execute drug development strategies.
• Develop and manage Integrated Development Plans (IDPs), program timelines, milestones, and critical path activities.
• Lead cross-functional planning across Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, CMC, Safety, and Nonclinical functions.
• Support programs from IND-enabling activities through clinical development and key regulatory milestones.
• Lead planning activities for early-stage programs, including IND/CTA preparation and early clinical development.
• Support late-stage development programs and major regulatory submissions, ensuring cross-functional readiness.
• Drive governance, risk management, scenario planning, resource forecasting, and budget planning.
• Partner with Clinical Operations to support enrollment, study execution, and issue resolution.
• Drive accountability across matrixed teams and prepare executive-level communications and governance materials.
• Promote operational excellence and continuous improvement initiatives.

Skills

Cross-functional leadership

Executive communication

Program management

Risk management

Education

Bachelor's degree

Tools

Microsoft Project

Office Timeline

Job description

Our client is seeking a Drug Development Program Manager to support both early-stage development programs (IND/CTA preparation and transition into clinical development) and late-stage programs supporting major regulatory submissions. This individual will partner with Global Program Leads (GPLs), Global Project Managers (GPMs), Clinical Science, Therapeutic Area leadership, and cross-functional teams to drive Integrated Development Plans (IDPs), strategic execution, governance, and risk management across the drug development lifecycle. Candidates should possess experience supporting early-stage development programs, major product submissions, or ideally both.

Responsibilities

• Partner with GPLs, GPMs, Clinical Science, and cross-functional stakeholders to develop and execute drug development strategies.
• Develop and manage Integrated Development Plans (IDPs), program timelines, milestones, and critical path activities.
• Lead cross-functional planning and execution across Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, CMC, Safety, and Nonclinical functions.
• Support programs from IND-enabling activities through clinical development and key regulatory submission milestones.
• Lead planning activities for early-stage programs, including IND/CTA preparation and early clinical development.
• Support late-stage development programs and major regulatory submissions, ensuring cross-functional readiness and execution.
• Drive governance, risk management, scenario planning, resource forecasting, and budget planning activities.
• Partner with Clinical Operations to support enrollment, study execution, and issue resolution.
• Drive accountability across matrixed teams and prepare executive-level communications and governance materials.
• Promote operational excellence and continuous improvement initiatives.

Qualifications

• Bachelor's degree required.
• 8-10+ years of experience within pharmaceutical, biotechnology, or drug development organizations.
• Experience supporting development programs from IND-enabling activities through clinical development.
• Strong understanding of the drug development lifecycle, including clinical, regulatory, nonclinical, and CMC activities.
• Experience leading complex cross-functional development programs within matrixed organizations.
• Excellent communication, presentation, and executive-facing skills.
• Ability to work onsite 2-3 days per week (50%) in Princeton, NJ, Cambridge, MA, or Brisbane, CA. This requirement is non-negotiable.

Preferred Qualifications

• Advanced scientific or business degree (MS, MBA, PharmD, or PhD) preferred.
• PMP certification is a plus.
• Experience with Microsoft Project, Office Timeline, and similar project planning tools