Clinical Development Director - Gastroenterology sought for the Gastroenterology/Hepatology group in Clinical Science. You will support the Clinical Development Lead and clinical team to plan and execute studies for GI indications, develop future Phase 2/3 clinical programs as well as overall life cycle management plans, and participate in business development assessments.
This role will provide you the opportunity to lead key activities to progress your career. Job purpose and key responsibilities:
Why you?Basic Qualifications:
- Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in early and/or late phase 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
- Enabling key decision points and Go/No Go criteria for the CDP
- Enable robust protocol design, including selection of clinical endpoints, patient populations and participant monitoring strategy.
- Developing and maintaining relationships with program counterparts in Commercial, Research, Discovery Medicine, 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 gastroenterology and/or hepatology 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
- MD, PhD, and/or PharmD degree
- Experience in clinical and/or academic gastroenterology and/or significant gastroenterology drug development experience 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.
- Knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
- Solid understanding of needs and priorities of regulators, payors 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
- Understanding of integrating genetic data to inform and guide clinical protocols
- Proven ability to utilize statistics, and visualization techniques to interpret or analyze complex information and make correct inferences and conclusions
- Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
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. 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
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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