Medical Director

OPIS is currently looking for a Medical Director responsible for managing, leading and overseeing the activities of the Medical Department. Medical Director is responsible for ensuring client projects are delivered on time and with high-quality thus guaranteeing client's satisfaction.

Some of what you will do:

• Assume overall responsibility for ensuring the quality and timeliness of Medical Department deliverables to sponsors
• Provide the staff with daily guidance, leadership and overall support on issues relating to projects, communication, procedures and executing process to meet customer needs
• Ensure continuous availability to respond to urgent protocol-related issues at the investigative sites, as needed
• Ensure all pharmacovigilance requirements are met
• Define KPI/KQI to guarantee excellent performance, high quality and timely deliverables and maintaining strong relationships with the key stakeholders and partners
• Oversee the activities of the consultants/third party vendors of the Medical Department and approve the related invoices
• Anticipate areas of risk, and plan and implement solutions to mitigate these risks
• Participate in discussions with Regulatory Authorities as appropriate
• Attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• Define the timeframes and costs of each project and collaborate with the Business Development and the Finance in preparing the biddings and invoices for the sponsor
• Ensure the management of appropriate billable and non-billable time for his/her team and ensure that the activities are entered in the TRACK system, billed and invoiced on time
• Lead Medical Department personnel through inspection/audit situations, including closing out inspection/audit findings and corrective action plans
• Keep Senior Management informed on project progresses and potential issues and ensure alignment with Senior Management on any adjustment
• Conduct annual performance review for his/her staff and provides career development opportunities
• Ensure compliance with SOPs, quality standard, ICH-GxP, and other national and international regulatory requirement
• Utilizes communication skills to reinforce Corporate culture, motivate staff and develop effective working relationships

Minimum Requirements

• Degree in Medicine
• At least 10 years of experience in clinical research, including CRO and/or R&D experience
• Experience in providing medical strategy, direction, development and review for a variety of activities and deliverables
• Strong commitment to quality, organization, planning and budget management skills
• Strong analytical skills, attention to detail, and business process orientation with strategic acumen
• Excellent English language (fluent reading, writing and verbal skills)
• Excellent leadership, presentation, communication and interpersonal skills
• Customer/client orientation, with a strong sense of urgency and results orientation
• Excellent ability to develop important relationships with internal and external key stakeholders
• Excellent ability to motivate and inspire team members

We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.

Please read the information notice on the processing of personal data in the candidates information section of our company website.

We are looking forward to speaking with you!

Who we are:

Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.

OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.