Reference Number: JO-2012-459445
Medical Director – Safety
Job Type: Permanent
Location: Central London / West End
Medical Director, Safety
The Safety Clinician is responsible for the oversight of all safety aspects of Company clinical trials. In this role, the Safety Clinician will be responsible for ensuring that the appropriate measures are taken to protect the patient and the company, the ongoing review of data in all studies, identifying trends in safety and efficacy and proactively mitigating risk. The role will report to the Chief Executive Officer and be highly visible in the strategic direction of the business as they advance multiple assets through clinic.
PATIENT SAFETY/MEDICAL MONITORING
Leads all aspects of medical monitoring across all clinical trials.
Be the Medical Expert (Medical Monitor) for assigned clinical trials which includes being readily available to advise on trial-related medical questions or problems during the conduct of the trial during and after study conduct
o Review of lab critical values
o Ongoing medical support for investigator sites during the study
Represent the patients interests ensuring their safety at all times in clinical trials
Represent company interests where necessary, including protecting company in advance of an safety issues for its clinical trials
Work closely with the pharmacovigilance and safety representatives on trials providing medical input into safety reports.
Abides to the deadlines for expedited submissions; codes according to coding dictionaries; communicates with study team and competent authorities as required
Authors the Integrated Summary of Safety and Integrated Summary of Efficacy where applicable to an assets development.
Responsible for medical monitor expert input into the development and implementation of standard operating procedures for all aspects of Adverse Event report handling, aggregate reporting and assuring compliance with global and local regulatory requirements.
Proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data safety and protocol deviation review.
Participates in all stages of the clinical trial set-up process including feasibility assessment, investigational site selection, protocol design and amendment, CRF and IRT design and CSR publications
Evaluation of subjects eligibility for inclusion into specific studies. Discusses study issues with clinical investigators where necessary.
Contributes to CRO, CRA, investigator and site training
CLINICAL DEVELOPMENT TEAM
Works in close partnership with Clinical Development team members, providing medical support to all aspects within the Clinical Development Function
Part of the wider functional service provider model which the Clinical Development team operates, able to engage with and manage external consultants and vendors as appropriate
Support CPMs in the authoring of and approval of Informed Consent Documents (ICDs), including responses to external stakeholder questions.
Provide clinical input to the TPP, Development Plan, Statistical Analysis Plan, tables/listings/figures, and data review.
Provides clinical input to development of protocol writing and study quality plans
Provides clinical input into literature reviews.
Participates in activities related to other departments within the company where required/appropriate.
Skill and Experiences
A medical degree (with a GMC license to practise or US Board certification) with significant direct experience in the pharmaceutical industry, ideally investigational drug development, which must include medical monitoring.
Experience in oncology clinical trials is desirable.
Understanding of local and global drug safety regulations/guidelines and processes and clinical trial oversight, including global GCPs and adverse event management.
Experienced in providing input into key regulatory documentation.
Demonstrated understanding of the complexities and recent developments in oncology.
Confident discussing scientific/mechanistic aspects of drug development and comfortable discussing commercial and regulatory issues.
Experience in communicating via presentations to a wide variety of audiences including internal teams and medical/scientific communities.
Passionate about the vision and mission.
Pragmatic; willing and able to roll up sleeves in a fast-moving, smaller company environment.
Confident demeanour, capable of navigating discussions with senior colleagues
Collaborative and inclusive working personality
Excellent interpersonal, communication and presentation skills with ability to engage both internal and external stakeholders
Well-developed problem-solving skills.
Experience working with outside consultants in a positive and collaborative fashion.
For further information and to apply please contact Jon Phillips on 01189 522 799 or email Jon.Phillips@cpl.com