Clinical Program Manager

About the Role

The Manager, Program Management oversees internal and partnered drug development programs, ensuring consistency across functions and driving cross-functional collaboration to enable efficient, high-quality delivery from preclinical stages through early clinical development. This role leads program teams through IND-enabling activities, clinical trial start-up, and early phase execution, while building program management infrastructure, processes, and best practices that support a growing biotech portfolio.

Responsibilities

• Lead and manage cross-functional program teams to advance assets into and through clinical trials, with a focus on IND-stage and early Phase 1 programs.
• Partner with project teams and functional leaders to define program strategies with clear options, set goals and milestones, and develop detailed asset development plans.
• Track and report program progress, proactively identify gaps and risks, escalate issues as needed, and drive timely resolution to keep programs on track.
• Establish and enhance program management infrastructure, including standards, policies, and processes, in partnership with the Portfolio, Program & Alliance Strategy organization and other key stakeholders.
• Collaborate with functional leadership to drive operational excellence across the organization, ensuring consistent ways of working and efficient execution.
• Enable efficient drug development by fostering highly effective, inclusive, and collaborative program and alliance teams that support robust discussions and optimized operational plans.
• Support product and governance decision-making by organizing and running effective meetings, ensuring high-quality materials, clear decisions, and thorough follow-up on action items.
• Ensure clear, consistent, and transparent program communication across the organization, including systematic reporting such as monthly status reports, milestone tracking, and portfolio updates.
• Partner with Finance, Business Operations, and other stakeholders to support corporate program planning, including cross-functional resource planning, scenario planning, and financial assessments.
• Drive detailed IND planning and execution, including coordination of IND-enabling activities, submission readiness, and regulatory submissions in additional regions to support study expansion.
• Support early development programs in oncology and/or autoimmune indications, including study start-up and coordination with clinical operations and regulatory teams.
• Collaborate with external partners and CROs as needed to support clinical and regulatory activities for early-stage programs.
• Utilize Smartsheet and other project management tools to develop and maintain detailed program plans, timelines, risk registers, and dashboards.
• Support organizational initiatives and special projects as needed, contributing program management expertise to evolving business needs.
• Model and promote a collaborative, energetic, agile, organized, inclusive, curious, forward-thinking, and action-focused culture within program teams and across the organization.

Qualifications

• Bachelors degree in life sciences, engineering, or a related discipline.
• Minimum of 8 years of program or project management experience in the biotech or pharmaceutical industry, leading cross-functional development programs.
• Proven experience managing IND-enabling execution and submission readiness, including detailed planning and coordination of IND activities.
• Experience supporting first-in-human or early Phase 1 clinical programs.
• Experience supporting programs through preclinical development and transition into early clinical development.
• Demonstrated ability to manage complex timelines, cross-functional dependencies, and risk in fast-moving, ambiguous environments.
• Strong project and program management skills, including mastery of Smartsheet for planning, tracking, and reporting.
• Experience working in a matrix-style environment and serving as a program manager on cross-functional development teams.
• Strong understanding of early drug development, including nonclinical, CMC, regulatory, and early clinical activities.
• Experience working in GxP-regulated environments.
• Excellent written and verbal communication skills, with the ability to influence and drive alignment without formal authority.
• Advanced computer skills and experience with Microsoft Office products (e.g., Excel, PowerPoint, Word, Outlook).

Additional Skills & Qualifications

• Masters degree, PhD, or other advanced degree in life sciences, engineering, or a related discipline.
• PMP or equivalent program or project management certification.
• Prior experience in cell and gene therapy programs.
• Experience in oncology and/or autoimmune indications, particularly in early development.
• Experience in working with clinical programs and CRO partners.
• Experience as a program manager in a growing or start-up biotech organization.
• Demonstrated ability to thrive in a highly collaborative, fast-paced, and evolving environment.
• Comfort operating in a matrix organization with multiple stakeholders and competing priorities.

Work Environment

This role operates in a hybrid work environment with onsite presence in the East Lake area of Seattle, WA, offering longer-term potential for continued engagement. The position involves close collaboration with cross-functional teams across research, nonclinical, CMC, regulatory, clinical, finance, and business operations functions, as well as external partners and CROs. Work is conducted in a modern biotech setting focused on innovative immunotherapy, oncology, and potentially autoimmune and gene therapy programs. The organization uses Smartsheet and Microsoft Office as core tools for program planning, tracking, and communication. For candidates working fully remote, the assignment is structured as a 12-week engagement.

Job Type & Location

This is a Contract position based out of Seattle, WA.

Pay

The pay range for this position is $70.00 - $90.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan with pre-tax and Roth post-tax contributions
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)