Head, Program and Study Management – Non-Oncology

Jobtailor; New Jersey; On-site; USD 250,000 - 400,000; Full time

Job summary

Jobtailor in United States is seeking a Senior GCTO to lead clinical trial operations strategy and delivery across the portfolio. You will be accountable for overall program execution, ensure regulatory compliance, and drive cross-functional collaboration to accelerate development.

The role requires 12+ years in pharma/biotech/CRO with a track record of mentorship and implementing AI/automation in operations.

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• Advanced degree (Master's/PhD/PharmD) strongly preferred.
• 12+ years in pharma/biotech/CRO with clinical trial operations focus.
• Single-point accountability for successful execution of clinical programs.
• Experience building talent pipelines and leadership development.
• Expertise in the designated TA and its operational challenges.
• Proven use of AI, automation, and predictive analytics to modernize operations.
• Budgets, resource allocation, and cost-reduction with faster cycle times.
• Strong GCP/ICH knowledge and global regulatory expectations.
• Executive presence and ability to influence across global R&D teams.

Responsibilities

• Contribute to development and execution of GCTO vision, strategy, and goals.
• Serve as GCTO accountability for assigned TA(s).
• Translate scientific objectives into robust operational strategies.
• Own operational planning, execution, and delivery of clinical program portfolio.
• Ensure proactive cross-functional collaborations for trial delivery strategies.
• Provide senior oversight for all phases of clinical trial management.
• Drive CtQ alignment at program level.
• Act as escalation point for complex operational issues.
• Ensure activities comply with GCP, ICH, and global regulatory requirements.
• Build organizational talent and foster an environment for growth.
• Champion modernization of clinical trial operations.

Skills

Clinical Program Management

Operational Planning

Budget Management

Resource Allocation

Predictive Analytics

Education

Bachelor's degree in a scientific discipline

Advanced degree (Master's/PhD/PharmD)

Tools

AI Solutions

Automation Tools

Job description

Responsibilities

• Contribute to the development and execution of the GCTO vision, strategy, and goals.
• Serve as the GCTO point of accountability for the assigned TA(s).
• Translate scientific and TA objectives into robust operational strategies.
• Full accountability for the operational planning, execution, and delivery of the clinical program portfolio.
• Ensure proactive cross-functional collaborations to develop robust trial delivery strategies.
• Provide senior oversight for all phases of clinical trial management.
• Drive alignment of CtQ factors at program level.
• Act as the primary escalation point for resolving complex operational issues.
• Ensure all activities are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulatory requirements.
• Build organizational talent and create a work environment for teams and individuals to reach their full potential.
• Champion the modernization of clinical trial operations.

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 compliance with GCP/ICH guidelines and global regulatory requirements. Proven ability to lead cross-functional teams, drive operational strategies, and modernize clinical operations through digital solutions.

Highest-signal resume keywords

• Clinical Trial Operations
• Regulatory Submissions
• GCP/ICH Compliance
• Digital Solutions Implementation
• Talent Development

ATS Optimization Keywords

Hard Skills

• Clinical Program Management
• Operational Planning
• Budget Management
• Resource Allocation
• Predictive Analytics

Soft Skills

• Executive Presence
• Influencing Without Authority
• Cross-Functional Collaboration
• Mentorship

Industry Keywords

• Pharmaceutical Industry
• Biotechnology
• CRO Industry
• Life Sciences

Tools & Technologies

• AI Solutions
• Automation Tools