Senior Medical Director

Senior Medical Director

GW Pharmaceuticals

London, United Kingdom

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, and other regulatory submissions, as well as generates and/or reviews publications, posters, and scientific presentations;
  • Advises Medical Affairs in developing and implementing publication plans;
  • Presents clinical data represents GW Pharmaceuticals at professional meetings and meetings with authorities;
  • Represents Clinical Sciences at internal meetings;
  • Other duties as assigned;
  • Travel may be required approximately 20% of time, primarily for medical meetings, site visits, and meetings with authorities.

Requirements:

  • Industry experience required with full understanding of safety, rules and regulations of industry;
  • Robust drug development experience is recommended, preferably within the industry and with neurologic or psychiatric drugs. Experience with paediatric programs is a plus;
  • Board certification with a specialty in neurology, psychiatry and/or paediatrics preferred;
  • Active Medical license required;
  • NDA experience preferred;
  • Excellent oral and written communication skills and experience with publications;
  • Ability to work collaboratively in a dynamic team-based environment;
  • Possess a basic understanding of applicable US and EU regulations, the drug development process, biostatistics and pharmacokinetics.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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