Medical Director, Clinical Development, Immunology

• Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for asset(s) in development
• Ensuring alignment with and support of project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with IEP and CDP
• Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation, and value to patients.
• Providing effective support and oversight of evidence generation activities to assure patient safety and study delivery.
• Enabling robust protocol design, including selection of clinical endpoints, patient populations, and participant monitoring strategy
• Working with Clinical Operations and Biostatics to deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
• Active medical monitoring activities and medical data review of ongoing studies, including:
  Lead, coordinate activities and present at IDMCs, adjudication committees, ongoing routine safety review
• Interpretation and presentation of clinical data for clinical study reports and publications
• Oversee and train study team on protocol-related activities in collaboration with matrix study team members
• Developing and maintaining relationships with program counterparts, including Commercial, Research, Regulatory, Clinical Operations, and Statistics
• Interfacing and influencing a diverse range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs, align to business strategy, and address patient needs.
• Gathering and supporting the integration of inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to clinical components of the Medicine Profile
• Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
• Serving as a clinical representative for senior management and senior level matrix teams, both internally and externally for an asset in development
• Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in RIIRU
• Supporting technical and leadership development of RIIRU staff via mentoring and coaching for matrix team members
• Support enterprise efforts to streamline and grow efficiencies for the business unit

• Medical degree and clinical medical specialty training board qualification/registration in Internal Medicine or Primary Care/Family Medicine with specialized experience in IgE mediated disease and food allergy.
• Experience in clinical drug development, with experience of clinical trial execution from concept to publication.
• Clinical research experience in food allergy, including clinical development planning and interventional study design.
• Experience with in‑stream medical oversight activities during trial conduct.
• Experience with ICH guidelines, FDA requirements, and global regulatory expectations.
• Experience in clinical research methodology and biostatistical principles to support innovative and efficient clinical trial design and data‑driven decision rules.

Demonstrates expertise in clinical drug development and trial execution, with a strong focus on clinical research methodology and regulatory compliance. Capable of effective medical oversight and protocol design, ensuring alignment with strategic goals and patient safety.

• Medical Degree
• Clinical Drug Development
• Clinical Research Methodology
• ICH Guidelines
• FDA Requirements

• Clinical Trial Execution
• Interventional Study Design
• Medical Monitoring
• Data Review
• Protocol Design
• Clinical Endpoint Selection
• Patient Population Strategy
• Biostatistical Principles
• Evidence Generation
• Regulatory Interactions

• Mentoring
• Collaboration
• Influencing
• Communication
• Leadership

• Clinical Medical Specialty Training Board Qualification

• Integrated Evidence Plan
• Clinical Development Plan
• IgE Mediated Disease
• Food Allergy
• Regulatory Compliance
• Patient Safety
• Commercial Goals
• Study Delivery
• Decision Points
• Matrix Team Collaboration