Senior Clinical Program Manager

TCWGlobal; San Diego (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

TCWGlobal is seeking an experienced Senior Clinical Program Manager to lead the planning, coordination, and execution of global clinical development programs within a biotechnology/pharmaceutical environment.

This role partners with Clinical Development leadership to drive clinical program strategy, manage integrated development plans, timelines, budgets, identify risks, and ensure milestones are delivered on schedule across both early- and late-stage programs, including IND/CTA and NDA/MAA

Qualifications

• Extensive clinical development and program management experience in pharma/biotech.
• Experience leading global clinical development programs across early- and late-stage drug development.
• Knowledge of regulatory milestones (IND/CTA, NDA/MAA).
• Understanding of drug development lifecycle and cross-functional dependencies.
• Ability to drive program objectives, influence stakeholders, and facilitate decisions.
• Strong project management skills and PM methodologies.

Responsibilities

• Lead planning and execution of global clinical development programs with aligned timelines and budgets.
• Develop and maintain integrated Clinical Development Plans and milestones.
• Partner with Clinical Operations to manage objectives, work plans, budgets, timelines, and deliverables.
• Identify risks and develop mitigation and contingency plans.
• Lead site activation and enrollment planning to ensure timely study execution.
• Coordinate across Clinical Operations, Regulatory, Biostatistics, Data Management, and Manufacturing.
• Manage external partners and vendors to meet contractual obligations.
• Facilitate program meetings and communicate progress to leadership.
• Support IND/CTA and NDA/MAA submission milestones across programs.
• Identify opportunities to improve program management processes and tools.

Skills

Clinical program mgmt

Global programs

IND/CTA submissions

NDA/MAA submissions

Lifecycle management

Stakeholder management

Smartsheet

PM methodologies

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

PhD in Life Sciences

Tools

Smartsheet

Job description

W2 Contract – 12 Months, Possible Extension

Position Summary

We are seeking an experienced Senior Clinical Program Manager to lead the planning, coordination, and execution of complex global clinical development programs within a biotechnology/pharmaceutical environment.

This individual will partner with Clinical Development leadership and cross-functional teams to drive clinical program strategy, manage integrated development plans, oversee timelines and budgets, identify risks, and ensure key milestones are delivered on schedule.

The ideal candidate brings extensive experience in global clinical development, early- and late-phase pharmaceutical programs, regulatory submissions, and strategic program management, with the ability to influence stakeholders and drive decision-making across multiple functions.

Key Responsibilities

• Lead the planning and execution of clinical development programs, ensuring alignment with overall development strategy, timelines, budgets, and objectives.
• Develop and maintain integrated Clinical Development Plans, project schedules, critical paths, milestones, and resource requirements.
• Partner with Clinical Operations leadership to manage program objectives, work plans, budgets, timelines, and deliverables.
• Identify program risks, dependencies, and potential delays; develop mitigation strategies and contingency plans.
• Lead site activation and enrollment scenario planning to establish realistic study timelines and ensure timely execution.
• Coordinate across Clinical Operations, Drug Safety/Pharmacovigilance, Biostatistics, Data Management, Clinical Trial Supply, Regulatory, and other development functions.
• Manage external partners and vendors, ensuring deliverables and contractual obligations are met.
• Facilitate clinical program meetings, drive cross-functional decision-making, document action items, and communicate progress to leadership.
• Support clinical development activities across early- and late-stage programs, including IND/CTA and NDA/MAA submission milestones.
• Identify opportunities to improve clinical program management processes, tools, and operational efficiencies.

Required Qualifications

• Extensive clinical development and program management experience within the pharmaceutical or biotechnology industry.
• Experience managing global clinical development programs across early- and late-stage drug development.
• Knowledge of regulatory development milestones, including IND/CTA and NDA/MAA submissions.
• Strong understanding of the drug development lifecycle and dependencies across Clinical Operations, Regulatory, CMC, nonclinical development, and manufacturing.
• Demonstrated experience managing integrated project plans, timelines, budgets, resources, risks, and cross-functional deliverables.
• Ability to independently drive program objectives, influence stakeholders, resolve conflicts, and facilitate decision-making.
• Strong project management skills and experience applying established project management methodologies.
• Proficiency in Smartsheet.
• Excellent communication, organizational, analytical, and stakeholder management skills.

Education & Experience

Candidates should meet one of the following:

• Bachelor's degree in Life Sciences with 12+ years of relevant pharmaceutical/biotechnology experience.
• Master's degree in Life Sciences with 10+ years of relevant experience.
• PhD in Life Sciences with 7+ years of relevant experience.

Relevant experience should include multidisciplinary pharmaceutical development, early- and late-phase program management, regulatory submission activities, and global drug development.

Preferred Qualifications

• Proficiency in Planisware
• Project Management Professional (PMP) certification.
• Experience supporting complex, strategically important clinical development programs.
• Demonstrated success driving cross-functional alignment and improving clinical program management processes.

TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.