Clinical Program Lead - IND & Early Trial Strategy

Actalent; United States; Hybrid; USD 96,000 - 124,000; Full time

Benefits offered by this job

Medical benefits

401(k) retirement plan

PTO

Job summary

Actalent is seeking a Manager, Program Management to oversee drug development programs from preclinical through early clinical development in a fast-moving biotech setting. You will lead cross-functional teams, drive IND-enabling activities, and build robust program management processes to enable high-quality delivery.

The role requires strong program leadership, expertise in IND planning, and collaboration with external partners and CROs.

Qualifications

• Bachelor's degree in life sciences, engineering, or related discipline.
• 8+ years in biotech or pharmaceutical program or project management.
• Experience leading IND-enabling execution and submission readiness.
• Experience with first-in-human or early Phase 1 programs.
• Experience guiding programs through preclinical development to early clinical development.
• Strong ability to manage complex timelines, dependencies, and risk.
• Proficient in Smartsheet for planning and reporting.
• Experience in matrix organizations and CRO collaboration.
• Understanding of early drug development and regulatory activities.
• Experience in GxP-regulated environments.
• Excellent written and verbal communication.

Responsibilities

• Lead and manage cross-functional program teams to advance assets into and through clinical trials.
• Define program strategies with goals, milestones, and asset development plans.
• Track progress, identify gaps and risks, and drive timely resolutions.
• Establish and enhance program management infrastructure and processes.
• Collaborate with leadership to drive operational excellence and consistent ways of working.
• Coordinate IND planning and submission readiness across regions.
• Support early development programs in oncology and/or autoimmune indications.
• Utilize Smartsheet and other tools to maintain detailed program plans and dashboards.

Skills

Program management

Cross-functional leadership

IND planning

GxP compliance

Smartsheet mastery

Regulatory submissions

Clinical development

Stakeholder management

Microsoft Office

Communication skills

Education

Bachelor's degree in life sciences or engineering

Masters/PhD preferred

PMP certification

Tools

Smartsheet

Microsoft Office

Clinical trial systems

Job description

Actalent is seeking a Manager, Program Management to oversee drug development programs from preclinical through early clinical development in a fast-moving biotech setting. You will lead cross-functional teams, drive IND-enabling activities, and build robust program management processes to enable high-quality delivery.

The role requires strong program leadership, expertise in IND planning, and collaboration with external partners and CROs.