Medical Director

Medical Director - IAI

Remote throughout Australia

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

OVERVIEW

Advanced Clinical are currently searching for a skilled professional to join a well-known client's team as a Medical Director in Australia. Their work will have a direct impact on not just the organization but the larger clinical research industry making this an amazing career opportunity.

The Medical Director will provide medical monitoring services of the Client's clinical trials. Activities include but are not limited to monitoring of adverse events, medical history, concomitant medications, inclusion/exclusion criteria, and drug safety support when requested and appropriate. The individual will provide scientific & medical support and guidance to the operational teams in all relevant aspects of projects, including appropriate and timely communication with Client project team members and departments.

RESPONSIBILITIES

• 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.
• Provide coverage for other colleagues and Emergency 24/7 medical coverage as needed.
• 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.
• Perform ongoing reviews of patient profiles and CRF data.
• Collaborate with senior medical Directors on the medical-operational aspects of complex clinical studies.

EXPERIENCE

• Minimum 3 years' experience in the pharmaceutical industry or related field. Prior Medical Monitoring experience in CRO preferred.
• Experience in late stage (phase 2 and 3) clinical trials.

EDUCATION

• MD with advanced clinical training

Qualifications

• 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.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.