Sr Clinical Development Director, Hepatology, Open to flexible working
As the Sr. Clinical Development Director - Hepatology, you will be the Clinical Development Lead for a phase 3 program in Primary Biliary Cholangitis (PBC). You will lead the clinical program and integrate pivotal studies for pruritus associated with PBC as well as asset life cycle management plans.
- 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
- 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
- Establishing expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP
- Developing and maintaining inclusive relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
- Contributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development
- Playing an active role in the development of Clinical Sciences staff via coaching and mentoring and direct line management of 2-4 direct reports.
Scientific Leadership, Direction and Strategy:
- Employs visioning and strategic thinking to provide expert guidance to support the disease/therapeutic area specific strategy for a drug(s) or program(s). Manages selected clinical development projects for products/franchise of compounds
- Serves as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development
- Guides, influence and positively interface 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
- Integrates inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Medicine Profile. Accountable for the clinical components of the Medicine Profile.
- Accountable for risk/benefit of the asset. Actively makes decisions which balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriate
- Assesses and predicts when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit
- Anticipates problems and proactively seeks input from other teams' members/functional lines within R&D. Uses scientific/operational expertise to solve study and/or project related problems
- Accountable for the evaluation of clinical study/program probability of technical success (PTS)
Study & Program Design and Evidence Generation:
- Drives the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management
- Leads clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses
- Provides effective guidance, support and oversight of evidence generation activities to assure patient safety and study delivery
- Delivers value and access insights to inform medical strategy, expand market access and to address unmet patient need
Creating Innovative Scientific and Technical Solutions
- Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology
- Champions implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions
- MD, PhD and/or PharmD degree
- 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
- Significant years of experience managing line and matrix teams with a strong reputation of inspiring and motivating high performance
- 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
- Extensive experience in GI & 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
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, 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
Closing date for applications: 14th May 2021
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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