(Associate) Director Medical & Safety

For the Medical & Safety team, we are looking for a (Associate) Director Medical & Safety . The goal of this function is to provide strategic direction and leadership to the Medical & Safety team in order to assure the continuous quality of safety and to ensure timely deliverance of safety services within clinical trials, project teams and business development proposals. You will work in a close-knit team of responsible colleagues. It is a diverse job in an organisation with short lines, with excellent opportunities to put your ideas for improvement into practice.

The (Associate) Director Medical & Safety will report to the Director Digital Innovation & Clinical Services.

On department level

• Provides strategic direction on all safety aspects of clinical trial set-up and management;
• Ensures a high level of medical and safety assessment is maintained within the team;
• Ensures adherence to company’s SOPs, policies and all applicable regulations and guidelines;
• Participates in (project) team meetings in order to provide and support the project team and Medical and Safety team with regard to safety information;
• Provides input into proposals and bid defences on safety activities in collaboration with the Safety Specialist;
• Manages scientific and medical activities with regard to safety specific issues in order to ensure implementation and proper conduct of protocols;
• Acts as line manager for the Medical and Safety team, including goal-setting for the team, coaching and encouragement of development of the team members;
• Stays abreast of latest developments in safety management, project management and drug development, and contributes to advances in the field.

On project / safety physician level:

• Adjudicates, advances and safeguards the health of our subjects by medical review, medical monitoring (including but not limited to: adverse events, medication, diagnostics) and signal management (early signals will be detected to ensure safety of subjects);
• Advises and informs investigators and sponsor on medical issues;
• Advises and informs ethical committees and regulatory authorities on medical issues;
• Advises investigators and sponsor on eligibility at individual subject level (compliance to all inclusion and exclusion criteria);
• Participates in steering committee and data review meetings as safety expert;
• Responsible for the process of safety reporting of the individual subjects participating in clinical trials within applicable regulations and according to EU Directive, guidelines;
• Advises on continuation of trial drug– if applicable.

• Medical Degree (MD) with a minimum of 10 years of experience, preferably with a minimum of 5 years’ safety experience, in either a pharmaceutical or CRO environment.
• Extensive knowledge of safety legislation and regulations and ICH-GCP guidelines;
• Good knowledge of the pharmaceutical industry/market;
• A minimum of 10 years’ experience, preferably including a minimum of 5 years’ safety experience, in either a pharmaceutical or CRO environment;
• 5 years of experience in line management;
• Detailed knowledge of the concepts of clinical research and drug development;
• Excellent communication skills in both English and Dutch.

An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions. An environment where you have room to be creative, take initiative and have direct influence on the way we work.

We are located in a beautiful monumental building, near Slot Zeist, close to public transport. Our employees have the flexibility to work from home or from the office or a combination of the two.

Interested in this position? Send your CV and motivation to vacancies@juliusclinical.com

QUESTIONS

If you have any further questions, please call Marjolein Jansen (Director Digital Innovation & Clinical Services (+31 621162948) or Ellen Hunink, HR Business Partner (+31 621162980).