Director, Clinical Development Operations Program Lead
About The Position
The Director, Development Operations Program Lead drives the clinical development operations program oversight and is accountable for the end-to-end development operational execution of clinical development programs. This role serves as the primary development operational lead at the program level and co-leads the Development Sub Team, translating clinical development strategy into executable global plans and ensuring timely, high-quality delivery of clinical milestones. The Director operates with a strong execution and strategic mindset, identifying and mitigating potential risks, leads program-level development operational decisions, and escalates cross-program, or portfolio level risks to the Senior Director. This role is critical to ensuring consistency, quality, and accountability across study execution in a highly outsourced model. This position reports to the Senior Director, Clinical Development Operations Program Lead.
Requirements
- Bachelor’s degree required; advanced degree preferred.
- 10+ years of clinical operations and clinical development operations program management experience, including hands-on trial management and strong understanding of the end-to-end drug development process.
- Demonstrated experience leading clinical programs in an outsourced CRO model.
- Strong Strategic mindset with proactive risk management and solution / results orientated.
- Strong knowledge of GCP, global regulatory requirements, and inspection-readiness expectations.
- Demonstrated ability to work cross functionally and lead with influence and motivating others.
- Excellent communication, organizational, and problem-solving skills.
- Ability to operate independently, manage complexity, and drive execution in a fast-paced environment.
- Willingness to travel as needed (approximately 15%).
Responsibilities
- Lead the integrated development operations plan for a clinical development program or defined group of studies.
- Translate clinical development strategy into detailed operational plans, timelines, and resourcing models.
- Manage program-level risks, dependencies, and critical path activities; proactively identify and escalate issues with proposed mitigations.
- Provides oversight of CRO, vendor, and site performance metrics within the clinical program.
- Lead Development Sub-Team and serve as Clinical Development Operations Lead in the Core Program Team.
- Proactively identify program risks and mitigations, work with cross-functional teams to develop contingency plans and escalate to the Sr. Director, Clinical Development Operations Program Lead.
- Execute program delivery within established Clinical Development Operations standards, processes, and vendor governance frameworks.
- Collaborate with external development partners to support alignment on program-level operational plans, timelines, and execution.
- Supports the Clinical Study Teams in holding CROs and vendors accountable for program-level performance, quality, timelines, and budget adherence.
- Coordinate resolution of program-specific CRO or vendor performance issues in collaboration with study teams and functional partners. Escalate systemic or cross-program vendor issues to the Senior Director.
- Support development and monitoring of program-level clinical budgets, ensuring alignment between operational plans, resourcing assumptions, and program priorities, and escalating financial risks as needed.
- Provide program-level operational status reporting, including timelines, risks, and key trade-offs, and prepare materials for program governance forums and milestone reviews.
- Support program readiness for audits and inspections by maintaining clear documentation of program status, risks, and key operational decisions.
- Lead program-level operational status reporting, including timelines, risks, and trade-offs.
- Prepare materials for program governance forums and milestone reviews.
- Provide program-level leadership and coordination across study-level operational teams to support effective execution of clinical development programs.
- Foster a collaborative and accountable working environment across internal teams, CRO partners, clinical vendors, and functional stakeholders.
- Support onboarding of new team members and external partners to the program, ensuring alignment with program objectives and priorities.
Benefits
- medical, dental and vision insurance
- life, long- and short-term disability insurance
- paid parental leave
- a 401K plan with company match
- unlimited vacation time
- tuition assistance
- participation in our Employee Stock Purchase Program (ESPP)
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What This Job Offers
Job Type
Full-time
Career Level
Director
