Senior Clinical Program Manager

Job Description

Senior Clinical Program Manager

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Onsite, San Diego, CA 92103

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W2 Contract – 12 Months, Possible Extension

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$54.48/hr + Benefits

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Position Summary

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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.

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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.

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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.

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Key Responsibilities

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

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

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Candidates should meet one of the following:

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• Bachelor's degree in Life Sciences with 12+ years of relevant pharmaceutical/biotechnology experience.
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• Master's degree in Life Sciences with 10+ years of relevant experience.
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• PhD in Life Sciences with 7+ years of relevant experience.
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Relevant experience should include multidisciplinary pharmaceutical development, early- and late-phase program management, regulatory submission activities, and global drug development.

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Preferred Qualifications

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• Proficiency in Planisware
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• Project Management Professional (PMP) certification.
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• Experience supporting complex, strategically important clinical development programs.
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• Demonstrated success driving cross-functional alignment and improving clinical program management processes.
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TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.

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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.