Senior Medical Director

Greenwich Biosciences, Inc ,
London, Greater London
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Job Description

ABOUT GW: GW Pharmaceuticals is a cutting-edge UK-based biopharmaceutical company that over the last 20 years has established a world-leading position in cannabinoid science and the development of regulatory approved medicines derived from cannabis. Our mission is to transform the lives of seriously ill patients and their families. In October 2018 our achievements were recognized by TIME magazine which named GW as one of the 'Top 50 Genius companies of 2018 that are inventing the future'. Having developed the world's first prescription medicine derived from the cannabis plant, Sativex, which treats spasticity due to multiple sclerosis GW has now developed an oral formulation of purified cannabidiol (CBD), (approved as Epidiolex in the U.S) for seizures associated with Lennox-Gastaut syndrome or Dravet Syndrome, two rare and severe early-onset, drug-resistant epilepsy syndromes. This is in addition to our deep pipeline of clinical stage cannabinoid product candidates under development for both orphan and non-orphan indications with a particular focus on neurological conditions. In the UK we have close to 750 employees from a diverse range of backgrounds and disciplines based on four sites in Cambridge, Kent, London and Andover, along with employees working in the field. We also have a strong presence in the U.S. with around 250 U.S. employees, based both in Carlsbad, CA and in the field. We are continuing to build out our teams and are looking for talented individuals dedicated to making a difference in the lives of our patients, and to exemplifying our company values. About the Role: In this role, the Medical Director has a key role in the development of strategies for clinical programs and designs the trials in cooperation with key internal and external stakeholders to advance early and late clinical programs. The Medical Director also implements, monitors, or evaluates clinical trials in relevant clinical development programs. The Medical Director will lead the study teams in interpreting trial results and in constructing the study reports. The Medical Director will work with Medical Affairs to produce timely publications written in partnership with external opinion leaders. The Medical Director may also present scientific data at professional meetings and meetings with authorities as well as internal meetings. The Medical Director will take responsibility to ensure all reports and literature from the clinical program are scientifically sound and accurate and will identify issues that require further study and/or expert evaluation. As such, the Medical Director will work closely with internal cross-functional stakeholders, external investigators, various corporate partners and regulatory authorities. Responsibilities: * Provides medical expertise on clinical drug development throughout life-cycle of compound: * Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material. * Provides or supervises medical monitoring including answering site questions on inclusion/exclusion criteria or other protocol questions, evaluating SAEs and AEs, reviewing laboratory and other safety parameters, patient profiles, medical history coded terms, concomitant medications, and provides medical expertise to project teams during life-cycle of study. * Provides therapeutic training relevant to specific study to the project team. * Attends and/or presents at investigator, internal and external project team meetings. * Defines criteria for, assesses and evaluates protocol deviations and recommends on actions to be taken. * Assumes responsibility for ethical and medical, aspects of study. * Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients. * Supports the feasibility group in developing feasibility plan and questionnaire, in determining type of investigational sites and in selecting countries and sites. Reviews feasibility results and report. * Assists the clinical team in selection and recruitment of investigational sites. * Develop clinical trial programs to support product registration and marketing. * Establish ongoing liaison with key opinion leaders, government officials, and healthcare organizations and ensure that significant developments in the field are identified and monitored. * Provide leadership and medical expertise in the development of clinical research strategic programs in line with global strategy and to support local product registration and marketing. * Provide medical and scientific input to global product development teams. * Provide medical expertise in the review of adverse experiences locally and contribute to global pharmacovigilance activities. * Supports generation of publications and expert reports: * Reviews and interprets study results and clinical study reports. * Generates expert reports and supports IAS/IAEs, NDAs/PLAs,

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