Medical Director - 0.5 FTE
- United Kingdom
- Permanent
- Full-time
- Understand medical monitoring requirements for assigned projects.
- Develop and review medical monitoring plans and other study related plans.
- Ensure the clinical integrity of the trial subjects and address safety issues during the conduct of the study.
- Act as the main medical resource to support the investigators and sites and study team members.
- Answer eligibility, protocol and safety related questions including routine and urgent queries.
- Maintain current knowledge and overall awareness in the primary field of interest, clinical development in general, and the assigned therapeutic area.
- Work closely with the Pharmacovigilance team providing causality, expectedness assessment and medical input into SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs).
- Review key study documents.
- Perform eligibility/pre-enrolment reviews to evaluate eligibility.
- Perform review of Lab alerts on a day-to-day basis.
- Review coding of Adverse Events, Medical History and Concomitant Medications.
- Support independent committees i.e. Data Safety Monitoring Boards (DSMB), Adjudication committees etc., as needed.
- Perform reviews of Listings of adverse events, medical history, lab data, concomitant medications, physical exams, vital signs, SAEs, AESIs, during the conduct of the study to check for any safety trends or signals, potential safety threats or risks.
- Review cumulative Adverse Event (AE) listings to check if reported AEs are in line with expected safety profile of study drug.
- MD with advanced clinical training
- Minimum 3 years’ experience in the pharmaceutical industry or related field. Prior Medical Monitoring experience in CRO preferred.
- Demonstrated ability to work collaboratively across all levels of the organization and to lead influentially. Strong interpersonal and negotiation skills.
- Analytical and problem-solving skills; detailed oriented, an independent and critical thinker.
- Excellent communication skills and written, verbal and presentation skills.
- Experience in late stage (phase 2 and 3) clinical trials.
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others