Clinical leader sought to provide late -stage development leadership and advice for hepatology assets/programs in Research and Development. As Sr. Clinical Development Director - Research Pipeline & Franchise Liaison Hepatology, you will be responsible for working with the Gastroenterology/Hepatology Disease Area Lead to define and implement an integrated and efficient strategy in Research and Development. You will work across the matrix to ensure a seamless and efficient portfolio transition from Research to Development, while working with the Early Development Team and Discovery Medicine Leader to define end-to-end clinical development programs. You will also collaborate with our Franchise partners to ensure optimal scientific understanding and presentation of the Hepatology portfolio within GSK.
This role will provide you the opportunity to lead key activities to progress your career.Job Purpose and Key Responsibilities:
Scientific Leadership, Direction and Strategy:
- Providing integrated and innovative clinical development strategy to support the creation and management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
- Strategic Leadership: Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the IEP and CDP
- Contributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development
- Establishing bridges with research and early clinical development departments at GSK to guide late-stage clinical development of early-stage assets applicable to liver disease
- Working with commercial colleagues to develop the medicine profile for investigational agents to benefit patients with liver disease
- Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics
- Working with Global Medical Affairs colleagues to organize scientific advisory boards to inform product development for liver disease
- Playing an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring and potential direct line management
Creating Innovative Scientific and Technical Solutions:
- Employing strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s). Leads selected clinical development projects for products/franchise of compounds
- Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development
- Leading and positively interfacing with and influencing across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need
- Integrating inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Medicine Profile. Accountable for the clinical components of the Medicine Profile.
- Delivering value and access insights to inform medical strategy, expand market access and to address unmet patient need
- Assessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit
- Anticipating problems and proactively seeking input from other teams' members/functional lines within R&D. Uses scientific/operational expertise to solve study and/or project related problems
- Determining the probability of technical success (PTS) the clinical study/program
Why you? Basic Qualifications:
- Overcoming obstacles by experimenting with and adopting new ways of working including digital tools and technology
- Championing implementation of innovative methods and processes within clinical development
We are looking for professionals with these required skills to achieve our goals:
- An experienced candidate with Bachelor's degree in a science related field
- MD, PhD and/or PharmD degree
- Extensive 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
- Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
- Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
- Proven ability to maximize and integrate genetic data to advance disease understanding and inform and guide clinical development plans
- 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 using new learning and digital tools to create innovation in other areas
- Expertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content
If you have the following characteristics, it would be a plus:
- Significant years of experience leading line and matrix teams with a strong reputation of inspiring and motivating high performance
Why GSK? Our values and expectations
- Vice President, Clinical Sciences, Disease Area Lead Gastroenterology/Hepatology/Renal
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, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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