Freelance MD/Medical Director
US-MA-Boston
PRA Health Sciences
Req #: 119962
Type: US-Northeast
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Overview: As a Medical Director, you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. Responsibilities: What You Will Be Doing: * Lead or support the clinical subteam and oversee the design and execution of multiple clinical studies or clinical programs. * Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees. * Functionally, supervise and develop medical monitors and/or clinical development scientists (CDS), if any and as assigned by the manager. * Lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents, as assigned by manager. * Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents) * Determine appropriate external experts for advisory boards, steering committees, adjudication committees, and/or data monitoring committees, and lead the team in preparation for meetings. * Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic area strategy. * Serve as the Medical input to the Global Development Team/Subteam and the Medical Expert for clinical study team. * Conduct medical monitoring activities during periods of vacations, team restructuring, team departures or in other situations, as assigned by manager. * Lead the presentation of clinical trial related information/data to senior management, as assigned by manager. * Liaise internally with other members of the clinical development team to drive overall program strategy and development plans. Represent Clinical Development at the Global Program Team. * Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review. * Support business development activities, such as due diligence and research collaborations, as assigned by manager. * May serve as the Translational Science lead for one or more programs, as assigned by manager. * Working as part of a cross-functional team with colleagues representing biostatistics, data management, clinical pharmacology, commercial, regulatory, safety, quality, and project management, or others, as assigned by manager.. * Lead Pediatric Program Design and Execution, if applicable and as assigned by manager. * Be accountable for the overall integrity of the data in the clinical trial. Qualifications: You Are: * Physician with MD or foreign equivalent; PhD nice to have * 5-10 years of clinical development experience preferably within industry * 3-5 years minimum experience as a medical monitor for clinical trials required * Regulatory experience required * Track record of publication in peer reviewed journals, preferably first-authored publications * Excellent written / oral communication skills * Attention to detail and ability to think strategically * Willingness to take on new responsibilities * Interest and ability to learn about new therapeutic areas * The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * 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 Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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