Clinical Program Manager

Reports to: Executive Director, Head of Clinical Operations

Position Summary:

We are seeking an experienced and highly organized Clinical Program Manager to lead and drive the execution of our clinical development programs internally. In this role, you will be a key partner to senior leadership, responsible for the operational oversight of clinical trials and playing a critical role in the allocation and management of our product portfolio. The ideal candidate possesses strong leadership in managing cross-functional teams, deep expertise in direct trial execution, and the strategic acumen to support portfolio-level decision-making.

Key Responsibilities:

• Portfolio Support & Pipeline Management

· Collaborate directly with the Executive Director, Head of Clinical Operations and other senior leaders to support the strategic planning and operational execution of the entire product pipeline.

· Assist in the allocation and optimization of internal resources (personnel, budgets, and materials) across multiple clinical programs to ensure alignment with corporate milestones.

· Support portfolio-level risk assessment, identifying potential clinical or operational bottlenecks and proposing mitigation strategies for pipeline progression.

· Prepare and present program updates, pipeline analyses, and resource plans for governance committee reviews and investment decisions.

• Clinical Program Leadership

· Serve as the operational lead for assigned clinical programs, driving end-to-end execution from study start-up through close-out (Phase I-IV).

· Lead internal cross-functional study teams (including Clinical Research, Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs) to ensure studies are delivered on time, within budget, and in compliance with GCP/ICH guidelines.

· Develop and maintain integrated study timelines, detailed budgets, and risk management plans.

• Operational Excellence & Trial Execution

· Oversee all aspects of trial conduct, including site selection, investigator meetings, monitoring, data cleaning, and database lock, ensuring high-quality deliverables.

· Proactively identify and resolve complex operational issues, escalating critical findings to the Head of Clinical Operations as necessary.

· Ensure inspection-readiness for all trial master files (TMF) and relevant documentation.

• Strategic Oversight & Compliance

· Ensure clinical programs are executed in strict compliance with global regulatory requirements (FDA, EMA, etc.), ICH-GCP, and company SOPs.

· Contribute to the development and review of key clinical documents, including protocols, informed consent forms, clinical study reports, and regulatory submission components.

Qualifications:

· Education: Bachelor’s degree in Life Sciences, Nursing, or a related field required. Advanced degree (MS, PhD, PharmD, or MBA) preferred.

· Experience:

· Minimum [e.g., 5-7] years of experience in clinical research, with significant experience in direct, in-house global trial management.

· At least [e.g., 2-3] years of experience specifically in a Program Management role, managing complex programs or multiple trials simultaneously within a sponsor (pharma/biotech) environment.

· Proven experience supporting portfolio-level activities or working directly with senior leadership on pipeline strategy is highly desirable.

· Skills & Competencies:

· In-depth knowledge of ICH-GCP guidelines and FDA/EMA regulatory requirements.

· Proven ability to lead and influence internal cross-functional teams without direct authority.

· Strong financial acumen with experience in budgeting, forecasting, and resource management in a direct-operations model.

· Exceptional organizational and problem-solving skills with the ability to manage competing priorities in a fast-paced, dynamic environment.

· Excellent verbal and written communication skills; ability to present complex information clearly to senior management and diverse internal stakeholders.