Senior Epidemiologist

Senior Epidemiologist

Location –Vancouver, Canada office

ICON Late Phase Outcomes Research/Oxford Outcomes is seeking a Senior Epidemiologist with a clinical focus.  The successful applicant will work with a capable and maturing team of epidemiologists and analysts in the growth of the Practice, and will report to the Senior Director and Practice Leader of Epidemiology.

Overview of the role

·         Primary activities are focused on the operational and scientific aspects of the program managing all the functional lines involved (Phase I and/or Phase III)

·         Matrix working relationship within Clinical R&D and with other members of the project team (e.g. Statistics, Clinical Pharmacology, Development Operations, Regulatory, Pharmaceutical Sciences, Safety, Project Management, Commercial)

·         Lead development of a clinical protocol from outline to final protocol

·         Contribute to regulatory documents going to FDA and EMEA

·         Contribute to the design of the data output – how it will appear in the clinical study report

·         Lead development of a safety review plan and/or quality management plan

·         Support the MD clinician in reviewing and interpreting safety data

·         Set up and lead team meetings

·         Assist in the preparations of the clinical content of regulatory submissions/documents (e.g. Investigational New Drug application, Investigator’s Brochure, Package Insert)

·         Provide clinical input to study teams on case report form design, statistical analysis plan, monitoring guidelines, and drug supply planning, as needed

Role requirements

·         University training  degree in a medical or biological science discipline (BS required  MSc or  PhD preferred)

·         Minimum of 6 years of work experience in a similar role. Experience of working in healthcare/consultancy environment desirable

·         Medical and scientific understanding of a clinical discipline relevant to the assigned asset

·         Good understanding of drug development scientifically

·         Demonstrated technical, administrative, and project management capabilities, as well as effective verbal and written communication skills

·         Potential to design development plans and clinical studies

·         Ability to review and understand the emerging safety and efficacy profile of the drug candidate

·         Ability to understand the complexities and recent developments in the relevant therapeutic/technical area, and the ability to apply such knowledge to drug development

·         Ability to present clinical data, study plans and tactics clearly and accurately to relevant audiences in order to obtain decision

·         Additional valuable skills would include:

·      Demonstrated scientific productivity (e.g. publications, research reports, etc)

·      Understanding of local and international regulations applicable to clinical development

·      Practical experience in clinical trial strategies, methods and processes

Benefits

Working for ICON you will be provided with an excellent benefits package

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.

What’s next?

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

ICON is an equal opportunity employer M/F/D/V and committed to providing a workplace free of any discrimination or harassment.