Clinical Director - Bioelectronic R&D job in Stevenage, Hertfordshire
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Job Title - Clinical Director - Bioelectronic R&D
o Must have multinational (preferably EU) clinical trials experience including study management/coordination.
o Must have monitoring experience as site monitoring and/or co-monitoring will be required.
o Device development expertise
o Must be able to generally understand, interpret, and explain protocol requirements to others.
o Must be able to prioritize multiple tasks.
o Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
o Excellent teamwork, communication, decision-making and organizational skills are essential.
o Excellent matrix management, networking and communication skills (written, verbal) - proven ability to influence across a large organisation
o Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
We at GSK believe that in 1-2 decades bioelectronic medicines could become a new mainstay of treatment in parallel with pharmaceuticals and vaccines (Nature. 2013 Apr 11;496(7444):159-61).
The Bioelectronics R&D unit is tasked with enabling and accelerating the advent of bioelectronic medicines, to be a leading integrator in the field, and become an emerging innovation leg for GSK (Nat Rev Drug Discov. 2014 Jun;13(6):399-400). During its two years of existence, the unit has built a strong pipeline of ~20 biology exploratory projects (each up to 12 months duration). These projects explore a disease critical role of "nerve X in disease Y", thereby demonstrating the effect of precision neuromodulation on a defined neural circuit close to the end organ. We have also been successful in leveraging external funding bodies by demonstrating the opportunity to use "electrical axis of control" for disease treatment. This has led to >$300 million towards bioelectronics by government funding agencies.
In this newly created role in GSK R&D Bioelectronics unit, the Clinical director role will be responsible for establishing and delivering early clinical studies across several therapeutic areas. Working closely with the Early Discovery Leaders (EDLs) they will be responsible for setting strategy, driving the progression of the early clinical portfolio with external principle investigators and Contract Research Organisations and mentoring and coaching the clinical team.
The successful candidate will join the Treatment Discovery team and will be accountable for:
o Drafting and coordinating review of relevant documents including protocols, informed consent, case report forms, monitoring plans, investigator brochures, and clinical study reports.
o Ensures trials are conducted to GSKs SOPs.
o Maintains study timelines.
o Contributing to development of study budget.
o Managing CROs/vendors.
o Coordinating review of data listings and preparation of interim/final clinical study reports.
o Contributing to development of abstracts, presentations, and manuscripts.
o Ensures effectiveness of site budget/contract process.
o May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
o Conducts monitoring/co-monitoring as required.
o Assists in determining the activities to support a project's priorities within functional area.
o Coordinates and supervises all aspects of a clinical study.
o Design scientific communications within the company.
o Provide clinical leadership to the early development teams in the design and delivery of translational medicine studies that deliver answers to key clinical questions
o Work with external KOLs/PIs/CROs to draft, review, submit and execute early clinical studies in accordance with internal and external medical governance
o Be an advocate both internally and externally for the high quality work that the Unit is engaged in
o Lead by example in terms of day to day behaviours consistent with GSK Values and Behaviours
ENSURING DELIVERY OF KEY BUSINESS GOALS
o Identify CRO partners and develop strategic relationships.
o Provide input into wider portfolio clinical reviews.
o Works with Early Discovery Leaders to manage clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.
o Interacts with cross-functional teams internally and externally to ensure trial progress.
o Will incorporate study logistics and planning to accomplish study objectives.
o Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
RELATIONSHIPS AND STRATEGY
o Build strong relationships across the bioelectronic unit in order to ensure an integrated clinical strategy
o Build strong relations with clinical groups across GSK especially in those groups that have a strong local presence
o Work within the matrix to facilitate dissemination of translational medicine
o Interact with other senior matrix leadership teams on key advisory and safety review boards
** Competitive Salary **
** Location - Stevenage, Hertfordshire **
Closing date for applications: 10th March 2017
When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
Thank you for your interest in this opportunity.
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