We are seeking a Clinical Development Lead for emerging indications and assets in the Respiratory C linical Sciences organi z ation . As Senior Director, Clinical Development , Respiratory
you will lead life cycle indications in our developing respiratory anti-viral portfolio, including inhaled therapies, novel monoclonal antibodies, and therapeutic vaccines. Key Responsibilities
The Senior Director, Clinical Development, Respiratory
will provide 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 optimi z e 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 .
Scientific Leadership, Direction and Strategy
- Establishing expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP .
- Developing and maintaining 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 organi z ational initiatives in Clinical Development .
- Playing an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring and potential direct line management .
- Employs visioning and 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 s to the business strategy and achieves mutual goals related to patient need .
Study & Program Design and Evidence Generation
- Integrating 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 leads and 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 .
- 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 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) .
- 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 .
Creating Innovative Scientific and Technical Solutions
- Provides effective leadership support/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 .
- Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology .
Why you? Basic Qualifications
- 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 or PharmD .
- Extensive experience in Respiratory 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 maximi z e 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 analy z e highly complex information including digital content .
- Preferably experience leading line and 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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