Medical Director, Clinical Development, Immunology

About the role

We are seeking a Medical Director, Clinical Development, Immunology for a clinical program in food allergy. The Medical Director, Clinical Development, Immunology will support the Clinical Development Lead (CDL) and clinical team to plan and execute a clinical program, consisting of late-stage studies in IgE mediated allergic disease, with an opportunity to support multiple indications as part of this program’s life cycle management plans. You will work as part of a cross-functional team to deliver on a high-priority program, while also contributing to a dynamic and collaborative clinical research community. This role will provide you the opportunity to lead key activities to progress your career.

Key Responsibilities

• 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
• Overseeing and training 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

Basic Qualifications

• 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

Preferred Qualifications

• Familiarity or experience in Chronic Urticaria and IgE mediated disease biology, therapeutic targets, and current/future treatment landscape
• Experience with site-facing interactions and/or activities supporting medical affairs, patient advocacy groups, or external organizations
• Demonstrated ability to lead line or matrix teams, with a strong reputation for inspiring and motivating high performance
• Experience engaging with regulators, payors, and prescribers in relevant markets
• Experience integrating genetic data to inform clinical protocols
• Proven ability to apply statistical and data visualization methods to interpret complex information, draw accurate conclusions, and support decision-making
• Experience using new digital tools and learning technologies to drive innovation