Clinical Development Director - Hepatology
We are seeking a Clinical Development Director for a clinical program in Liver Disease. The Clinical Development Director will support the Clinical Development Lead (CDL) and clinical team to plan and execute a clinical program, consisting of late-stage studies in liver 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 Sciences community of physicians and scientists.
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 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 patient • 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 to deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
• Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches
• Medical monitoring of ongoing studies(if an MD) and interpretation and presentation of clinical data for clinical study reports and publications
• 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 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
• Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
• Serving as a clinical point of contact 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 Clinical Sciences
• Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members Clinical Development Director - Hepatology
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: • MD, PhD and/or PharmD
• Significant experience in clinical drug development with an understanding of the hepatology disease space, the underlying biology, and potential therapeutic targets, as well as current and future potential treatment options
• Significant clinical research experience; understanding of clinical development planning and running clinical trials from concept 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
• Proven ability to utilize statistics and visualization techniques to interpret or analyze complex information and make correct inferences and conclusions Preferred Qualifications: If you have the following characteristics, it would be a plus:
• Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance
• Demonstrated experience integrating genetic data to inform and guide clinical protocols
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk
• Committed to delivering high quality results, overcoming challenges, and focusing on what matters, urgently developing medicines for patients
• Continuously looking for opportunities to learn, build skills, and share learning • Sustaining energy and well-being, building resilience in teams
• Developing people and building a talent pipeline
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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