Work with global and diverse teams and sponsors from biotech and pharma industries to provide medical expertise, consultation, and support to project teams. Engage with Worldwide teams and our sponsors from protocol development to regulatory submission.
Provide Global and/or Regional Medical Monitoring support to assigned clinical studies, including medical management and oversight; training project teams on therapeutic indications and protocol; review of study documents (protocols, safety data, clinical study reports), collaborate with pharmacovigilance to review and process Serious Adverse Events. Represent Worldwide Medical Affairs at investigator and project team meetings.
Collaborate with Worldwide Business Development to review and develop proposals, assess feasibility, attend general capabilities, or bid defense meetings.
Engage in company and department initiatives, contribute to and participate in company and Medical Affairs programs, trainings and marketing initiatives. Assist in the annual attainment of departmental budget reviews, revenue targets and any other activities.
Maintain working knowledge of GCPs and regulatory requirements relating to clinical development and safety. Assure compliance with ethical, legal and regulatory standards. Obtain medical expertise and knowledge of relevant projects, indications through review of research literature, attendance of relevant internal and external meetings/conferences.

Medical expertise and good medical judgement. Understanding of medical and clinical research norms and practices
Strong organizational and interpersonal skills in a fast-paced and rapidly changing environment. Ability to work independently and as a team member, to exercise independent judgment with sensitivity to decisions requiring supervisory approval, to handle multiple tasks, including rapid response in review of information and documents
Excellent written and verbal English and communication skills. Advanced skills in MS Office applications including Microsoft Word, Excel and PowerPoint, willing to learn new technical systems
Knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements
Doctor of medical or osteopathic medicine (MD or OD) degree from an accredited medical education institution, preferably with specialization in the advertised therapeutic area
At least 2 years of medical monitoring or study physician role in clinical research or related industry
Valid passport and ability to travel as required.

We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.