Clinical Operations Director, Asset Lead - Neuroscience
- United States
Site Name: Home Worker - GBR, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence
Posted Date: Sep 23 2020
Are you energized by building Neuroscience Clinical Operations strategies? If so this Clinical Operations Asset Lead role could be a great fit for you!
As the The Clinical Operations Asset Lead you will be accountable within Global Clinical and Study Delivery (GCSD) team for the operational delivery plan to execute the scientific strategy for an asset and associated studies, working in partnership with functional subject matter experts.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Accountable for delivery of a program of studies in Neuroscience, and be key point of contact for portfolio leaders (e.g. Early Development Leaders, Medicine Development Leaders, and/or Project Physician Leaders, as appropriate).
- Contribution to the Clinical Development plan (CDP) and the development of protocols that align to the CDP to ensure operational feasibility and consistency within the program.
- Leads resourcing discussions on behalf of Clinical Operations, making recommendations on strategy and endorse the vendor(s) for the program and studies in accordance with the Clinical Operations resourcing strategy & principles.
- Oversight of delivery quality by being the escalation point for the program in Clinical Operations, ensuring inspection readiness at all times and having regular interaction with Study Delivery Leads involved in the program such that they are aware of issues / risks / successes with study delivery as they occur.
- Models scenarios for optimal program/study delivery linked to value drivers and drives decisions for governance boards to optimise delivery with transparent implications to time, quality, risks and budget
- Drives innovative approaches to study delivery through external facing advances in technology and sciences
- Creation of strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring and pre-Clinical Development, to ensure consistent approaches to study delivery, data collection and reporting across a defined indication.
- Contribution of relevant knowledge of scientific and medical literature in the Neuroscience field to apply to operational goals.
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in life sciences
- 12 or more years of clinical operations experience
- Experience supporting Neuroscience clinical trials
- Experience in developing and writing study protocols, study procedure manuals, informed consent forms and clinical study reports
- Experience applying study management global regulatory guidelines such as ICH/GCP Experience working with investigators, external experts, Contract Research Organizations and vendors
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Neuroscience expertise, such as Alzheimer's and Parkinson's
- Advanced degree (e.g. MS, PhD, PharmD)
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
- Excellent leadership skills
- Excellent influencing and negotiation skills
- Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
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:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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