Our client is a Global CRO and they have an exciting opportunity for a Medical Director.
With expertise in clinical pharmacology, regulatory affairs, pharmacokinetics, pharmacometrics, biopharmaceutics, and bioanalytical, our client specializes in the strategy, management and execution of product development and early phase clinical development.
Role Summary
To assume ultimate responsibility for the safety, well-being and rights of trial subjects.
To assume responsibility for the proper conduct of clinical trials. To lead a team of appropriately qualified physicians who participate in study design, protocol preparation, reports, and recruitment of volunteers, clinical trial procedures and publication of completed studies. To ensure that studies are conducted in compliance with the protocol, Clinical Trials Regulations and Good Clinical Practice set out in UK law and other relevant regulatory and ethical guidelines.
To be the lead individual for clinical and research governance with the Clinical Unit(s), setting and maintaining standards with training and assessment, specifically including the management of medical emergencies and resuscitation by the Clinical Unit staff, and ensuring that competence is maintained.
To act as the main Principal Investigator for studies, playing an active role in the clinical trials.
To provide medical education in the Clinical Unit.
To provide support to the Business Development team where appropriate.
Role Responsibility
Travel (approximately 25%) domestic and/or international
Ensure that all team members understand their personal and collective responsibility for the conduct of clinical trials, especially for the safety of subjects.
Ensure that arrangements are in place to provide continuous medical cover at all times.
In collaboration with Director of Clinical Operations/designee develop the clinical and non-clinical skills and contributions of all groups as necessary, including secondments of nursing staff to the physician group and the development of extended roles (eg Nurse Practitioners), taking on direct line management responsibility where necessary.
Communicate effectively with members inside and outside the Clinical Unit and facilitate collaboration with project management and other clinical staff to ensure the study requirements are met.
Ensure systems are in place for dealing with problems in the performance and conduct of team members fairly and appropriately.
Observe and keep up-to-date with regulations and statutory codes of practice which affect one's work.
Take part in regular and systematic audits, contribute in the response preparation to any audit findings in a timely manner, ensuring any corrective and preventative actions are upheld.
Discuss new trials with other staff, sponsors and any other involved parties.
Assess the feasibility of conducting new trials under the auspices of available resources, equipment and expertise.
Review synopses, protocols and informed consent documents.
Attend and present protocols, safety reports and other documents at ethics committee meetings.
Be responsible for the proper conduct of the trials in accordance with UK law, Good Clinical Practice and other relevant guidelines, but delegate certain responsibilities and tasks to other team members.
Help with the medical issues involved in the screening and care of healthy volunteers and patients, monitoring adverse events and safety issues on a regular basis and ensuring that adequate medical care is provided to a subject with an adverse event.
Maintain confidentiality with regard to volunteers and clients in accordance with confidentiality agreements and the Contract of Employment.
Represent the company in medical and scientific meetings, seminars, workshops and congresses, giving lectures or presenting papers and supporting marketing and sales activities.
Experience and Qualification
Prior relevant experience of patient care post-medical qualification
In depth proven experience as a Principal Investigator in Phase I/Clinical Pharmacology studies including First-In-Man.
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Drivers license.
