## Medical Leadership in Clinical Trials We are seeking a **Senior/Medical Director (Medical Monitor)** to join our team at PPD, part of Thermo Fisher Scientific, in a remote capacity based in Malaysia. This full-time role offers the flexibility to work from home while providing critical medical oversight for clinical trials across the pharmaceutical product lifecycle. **In this position, you will:** - Manage all medical aspects of contracted tasks, ensuring compliance with company SOPs, client directives, Good Clinical Practice (GCP), and regulatory requirements. - Attend and present at investigator and sponsor meetings, providing medical consultation to clients, investigators, and project team members. - Support business development activities, contributing to departmental process improvement initiatives. - Provide therapeutic and protocol training on assigned studies as requested. - Assist in writing (interpretation of safety and efficacy data) and/or review of Clinical Study Reports (CSRs), IND/NDA reports, ICSRs, signal detection reports, periodic reports, Risk Management Plans (RMPs), REMS, CTD modules, and more, ensuring medical content accuracy and completeness. - Monitor all safety variables of clinical studies, including adverse events, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests. - Discuss all medical concerns with principal investigators and clients, using proper medical judgment in interpretation and decision-making regarding clinical situations as they relate to the investigational study. - Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites. - Perform data review as specified in client contracts and data validation manuals, including review of coding listings and/or full safety data to assess potential safety concerns. - Manage signal detection activities, generate aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities for marketed products. - Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted. - Exercise wide latitude in determining objectives and approaches to critical assignments, with complete independence in methods, techniques, and evaluation criteria. - Serve as a consultant and spokesperson for the functional area or as an external spokesperson for the organization on highly significant matters, creating formal networks with key decision makers. ## What We're Looking For - **MD or equivalent degree required.** Active medical licensure is preferred. - A combination of clinical experience and industry experience as follows: - Clinical experience in treating patients in hema oncology or a sub-specialty associated with your training (comparable to **2 years**); **and** one of the following: - Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator (comparable to **1-2 years**) in the industry; **or** - Direct experience in safety/pharmacovigilance (comparable to **2 years**). - Broad expertise or unique knowledge, with the ability to develop solutions to highly complex and unique issues that impact and address future concepts, products, or technologies. ## Work Arrangement & Schedule This is a fully remote position with a standard work schedule (Monday through Friday). While the role is home-based, you will collaborate closely with teams and stakeholders across the organization. ## About Us PPD, part of Thermo Fisher Scientific, is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. We deliver an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. --- _This job was found on [bandana.com](