Clinical Development Director, Hepatology
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham Posted Date: Oct 15 2021 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 Why you? Basic Qualifications: 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: 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 Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership and transforming our commercial execution. Now, we are making our most significant corporate change in more than 20 years, setting out a new ambition for creating value for shareholders and impacting the health of over 2.5 billion people over 10 years. With new ambition comes new purpose. For New GSK this is to unite science, talent and technology to get ahead of disease together- all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. It means innovating together, fusing ideas, capabilities, and know-how inside and outside of GSK. Our R&D focus is to deliver new vaccines and medicines, using the science of the immune system, human genetics and advanced technologies, together with a deep commitment to operating responsibly for all our stakeholders. And we remain committed to getting ahead of issues that matter for the sustainability of our company be it pricing and access, the environment, or stronger diversity and inclusion. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster, accountable for impact - with clear ownership of goals and support to succeed, and where we do the right thing - with integrity and care because people count on us. Closing date for applications: 21 November 2021 *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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