Basic Purpose of the Job

The Clinical Program Leader assumes Clinical Development responsibilities supporting early or late development projects, reporting to the Associate Global Head or the Global Clinical Programme Team Leader.

The Clinical Program Leader has a medical leadership role for a project or a portion of a project in clinical development, usually at Start of Development through Phase I–III.

The Clinical Program Leader provides medical/scientific, technical, and managerial direction to plans, programs, and procedures within project and indication areas to effectively develop new compounds and/or optimize the profile of existing compounds.

The Clinical Program Leader in Experimental Medicine Japan assumes responsibility for engaging External Experts (EEs) in Japan. A core element of this role is identifying and engaging experts with expertise in:

• Early clinical development
• Translational science
• Advanced modalities within the therapeutic area

and leveraging their scientific and operational insights to inform global early clinical development strategy.

Accountabilities

Clinical Development Leadership

Represents the specific Therapeutic Area on International Multidisciplinary Core Teams and takes clinical development responsibility for assigned projects, including:

• Definition of Target Product Profiles (TPP)
• Clinical Development Plans (CDP)
• Pediatric Investigational Plans (PIP)
• Core Clinical Trial Protocols
• Input to Project Analysis and Data Management Plans
• Investigator's Brochure
• Medical input to Company Core Data Sheet
• Annual Safety Reports / IND Safety Reports
• Preparation for key milestones:
  • Start of Development
  • Proof of Clinical Principle (PoCP)
  • Release of Full Development

Related Performance Indicators

• Provides medical oversight throughout protocol development, study conduct, analysis, and reporting.
• Responsible for continuous benefit-risk assessment.
• Provides medical leadership during regulatory meetings.
• Contributes to submission strategy and regulatory filings.
• Addresses safety issues.
• Oversees medical project budgets.

Cross-Functional Team Leadership

Serves as Chairperson of the Global Early Clinical Development (ECD) Team and/or Medical Sub-Team (MST), depending on project stage.

Responsibilities include:

• Proposing team members together with the (Associate) Therapeutic Area Head.
• Representing ECD/MST on:
  • Core Team
  • Therapeutic Area Leadership Committee (TALC)
  • Clinical Expert Committee (CEC)
  • Human Pharma Steering Committee (HPSC)

Additional activities:

• Oversees interactions with:

  • External experts
  • Advisory boards
  • Adjudication committees
  • Safety Data Monitoring Boards

• Reviews and approves publications related to the project in collaboration with the Medical Head.

• Identifies studies that should be conducted.

• Provides input into Medical Affairs strategic documents, including:

  • Scientific Platform
  • Publication Plan
  • Product Maintenance and Optimization Summary

Key Accountabilities of the Clinical Program Leader in Experimental Medicine Japan

External Expert Engagement

• Map and prioritize External Experts (EEs) in the region, including:

  • Indication experts
  • Translational clinicians
  • Phase II trialists

• Build and maintain relationships to obtain scientific input and support trial success.

• Facilitate scientific discussions to ensure regional expertise contributes to:

  • Emerging science and innovation relevant to TA Inflammation
  • Proof-of-Concept (PoC) study design, including endpoint selection
  • Biomarker strategy

Regulatory and Organizational Requirements

Operates within the requirements of global Standard Operating Procedures (SOPs) and working instructions.

Job Complexity

Complex due to:

• Global nature of the role
• Matrix organization
• Direct multidisciplinary interaction

Interfaces

Works with:

• Global matrix teams
• Regional BI counterparts
• External partners
  • Academic institutions
  • Investigators

Also interfaces with:

• Regulatory authorities
• International societies