senior Medical Director, Medical Affairs - Hematology - Europe - Remote

at  Worldwide Clinical Trials

WHO WE ARE

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.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

YOUR EXPERIENCE

• 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 love knowing that someone is going to have a better life because of the work we do.
  To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .
  Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law

WHAT YOU WILL DO

• 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.

WHAT YOU WILL BRING TO THE ROLE

• 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