Head, Program and Study Management – Oncology

Jobtailor; New Jersey; On-site; USD 165,000 - 210,000; Full time

Job summary

Jobtailor is seeking a senior leader to drive global clinical trial operations within the GCTO framework from New Jersey. You will align strategies across R&D and GCD, delivering clinical programs on time, within budget, and to high quality standards.

The role requires deep expertise in regulatory submissions, GCP/ICH, and predictive analytics, with a track record of developing talent pipelines and leading global teams to excellence.

Qualifications

• Bachelor’s degree in a scientific discipline is required; advanced degree strongly preferred.
• Minimum 12 years in pharma/biotech/CxO-level clinical operations and drug development.
• Single-point accountability for execution of clinical programs and regulatory submissions.
• Experience building talent pipelines and leadership development.
• Experience implementing digital solutions (AI, automation, predictive analytics) to modernize operations.

Responsibilities

• Lead the GCTO vision, strategy, and operational delivery of the clinical program portfolio.
• Act as the accountability point for the assigned TA(s) and interact with GCTO Functions and GCD leaders.
• Translate TA objectives into executable operational strategies for programs and studies.
• Ensure cross-functional collaboration and robust trial delivery strategies.
• Drive continuous improvement using KPI/KQI tracking and predictive analytics to mitigate risks.

Skills

Clinical Trial Operations

Regulatory Submissions

Predictive Analytics

GCP/ICH Knowledge

Talent Development

Education

Master’s degree in life sciences/related field

PhD in life sciences/related field

Tools

AI‑Enabled Solutions

Automation Tools

Predictive Analytics Platforms

Job description

• Contribute to the development and execution of the GCTO vision, strategy, and goals, ensuring alignment with the broader company, Research and Development (R&D) and Global Clinical Development (GCD) strategy
• Serve as the GCTO point of accountability for the assigned TA(s), partnering closely with GCTO Functions and GCD TA and CS Heads to provide strategic operational input into the overall clinical development plan
• Translate scientific and TA objectives into robust, executable operational strategies for all clinical programs and studies
• Guide GCTO teams to understand the competitive landscape, the scientific rationale for development programs, and the long‑term vision for assets
• Full accountability for the operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and with the highest standards of quality
• Ensure proactive cross‑functional collaborations to develop robust trial delivery strategies
• Inspire excellence and drive reliable, high quality delivery by continuous improvement of processes and KPI driven measurement approaches to track progress, identify risks early, and execute mitigations to ensure end‑to‑end clinical trial delivery
• Provide senior oversight for all phases of clinical trial management, ensuring performance against key indicators (KPIs) and key quality indicators (KQIs)
• Drive alignment of CtQ factors at program level
• Leverage predictive analytics and AI‑driven insights to proactively identify, monitor, and mitigate operational risks, ensuring program milestones are met
• Act as the primary escalation point for resolving complex operational issues affecting program and study delivery; working across functional leaders to support teams
• Ensure all activities are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulatory requirements
• Ensure readiness and leadership for GCD late‑stage development reviews, GCTO Ops review, inspections and audits
• Serve as the key operational partner to Clinical leadership, ensuring GCTO capabilities and strategies are fully integrated to meet the needs of the development pipeline
• Proactively builds and sustains strategic internal and external relationships to accelerate PSM priorities
• Provide visible, hands‑on leadership for a global team of program and study management professionals, fostering a culture of accountability, collaboration, operational excellence, quality and continuous improvement
• Champion the modernization of clinical trial operations by identifying and implementing innovative processes, simplification and AI‑and Automation‑enabled solutions

Requirements

• Bachelor's degree required with a concentration in a scientific‑related discipline strongly preferred
• Advanced scientific degree (Master’s, PharmD, PhD) in life sciences, medicine, or a related field strongly preferred
• Minimum of 12 years of progressive experience in the pharmaceutical, biotechnology, or CRO industry, with a primary focus on clinical trial operations and drug development
• Demonstrated track record of single‑point accountability for the successful execution of clinical programs, including pivotal registration trials and regulatory submissions
• Proven history of building robust talent pipelines, implementing structured mentorship/rotational programs, and cultivating future directors and program leaders
• Expertise in the designated TA with understanding of the specific operational challenges of the TA
• Proven experience implementing digital solutions (AI, automation and predictive analytics) to modernize clinical operations
• Demonstrated success managing organization budgets, optimizing resource allocation, and reducing costs while accelerating cycle times
• Strong knowledge of GCP/ICH and global regulatory expectations
• Exceptional executive presence with the ability to break down silos, influence without direct authority, and drive alignment across complex global R&D teams

Core Competencies

Demonstrates expertise in clinical trial operations and drug development, with a strong focus on strategic operational planning, execution, and compliance with GCP/ICH guidelines. Proven ability to leverage digital solutions, including AI and predictive analytics, to enhance clinical operations and drive organizational excellence.

Highest‑signal resume keywords

• Clinical Trial Operations
• Regulatory Submissions
• Predictive Analytics
• Good Clinical Practice (GCP)
• Talent Development

Hard Skills

• Clinical Program Management
• Operational Strategy Development
• Budget Management
• Resource Allocation
• Digital Solutions Implementation

Soft Skills

• Executive Presence
• Influencing Without Authority
• Cross‑Functional Collaboration
• Mentorship
• Continuous Improvement

Industry Keywords

• Pharmaceutical Industry
• Biotechnology
• CRO Industry
• Clinical Development
• Regulatory Compliance

Tools & Technologies

• AI‑Enabled Solutions
• Automation Tools
• Predictive Analytics Platforms