Clinical Development Director - Hepatology

Clinical Development Director – Hepatology sought for phase 2/3 program in Primary Biliary Cholangitis (PBC). The Clinical Development Director will support the CDL and clinical team to develop clinical program and integrate pivotal studies for pruritus associated with PBC as well as overall life cycle management plans.

This role will provide you the opportunity to lead key activities to progress your career.

Job purpose and key responsibilities:

• Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
• Ensuring alignment with and support to 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 patient in the shortest possible timeframe
• Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
• Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
• Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development
• Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members
• Actively contributing or leading the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in assigned therapy disease area
• Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development
• Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs and 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.
• Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches
• Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
• Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery

Basic Qualifications:

• Bachelor’s degree in a science related field
• Significant experience in Hepatology clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
• Significant clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
• Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
• Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s)
• Demonstrated experience using new learning and digital tools to create innovation in other areas
• Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
• Demonstrated experience integrating genetic data to inform and guide clinical protocols
• Proven ability to utilize statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• MD, PhD or PharmD degree valuable but not required
• Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance