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Job #02777

About our client Our client is an international CRO headquartered in New York that is focused on the development and commercialization of various oncology and dermatology therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Director Medical Affairs Rye Brook, New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide direct and supportive medical oncology services to multiple clients 2) Interact with the sponsor in protocol reviewing or development 3) Perform literature analysis of therapeutic areas involved in the sponsor’s clinical development 4) Manage all aspects of medical monitoring specifically focusing on oncology (patient eligibility, protocol deviations and protocol interpretation) 5) Work in a matrix environment with Clinical Affairs (project managers, lead CRAs, etc.), Data Management and Biometrics 6) Create team structures, including a defined decision-making process that supports objectives and meets timelines 7) Communicate with clients and client project managers, to promote project schedule adherence 8) Ensure that projects are adequately staffed with personnel and resources and also meet high-quality standards 9) Provide guidance on medical and scientific issues 10) Interact with principal investigators and opinion leaders 11) Develop and maintain work guidelines, department metrics and project tools 12) Coordinate training and education programs to ensure that the staff is trained (as needed), including relevant therapeutic areas (focusing on oncology), ICH guidelines and regulatory requirements 13) Collaborate with the staff, inter- and intra-departmentally on proposal development process 14) Make presentations and represent the company at professional meetings as well as with prospective and existing clients 15) Participate in business development presentations (as required) 16) Manage personnel activities and provide guidance for professional development of staff 17) Coordinate resource distribution across projects and conduct interviews 18) Make hiring recommendations and lead disciplinary actions 19) Participate in business development visits to current and potential clients 20) Deliver performance reviews with a focus in therapeutic expertise 21) Participate in staffing the company’s exhibit booth at medical conferences 22) Contribute to scientific publications by reviewing for scientific accuracy, content, consistency and conclusions 23) Collaborate with business development in review, writing, presentation and defense proposals 24) Interact with the Clinical Safety Department and investigators regarding pharmacovigilance and study implementation 25) Provide leadership and supervision with an oncology focus within Medical Affairs 26) Oversee successful clinical input and medical monitoring for multiple clients 27) Provide guidance and support to project teams 28) Interface with sponsors and regulatory authorities 29) Work with sponsors and Medical Affairs in protocol development and/or review 30) Perform all other duties as assigned Requirements 1) Medical degree (MD) 2) 5 – 7 years of industry experience, including at least 3 years of clinical trial experience (or minimum 5 years of industry experience and/or clinical trial experience with drugs, devices or biologics) 3) Medical license (Board certification a plus) 4) Experience in working for a CRO (management experience preferred) 5) Experience in clinical development plans of new chemical entities, biological products and devices 6) Experience in CDER, CBER, CDRH and international regulatory agencies a plus 7) In-depth knowledge of the drug development process 8) Proficiency in operating computer applications and navigating the internet 9) Superb organizational skills with ability to work in a high-volume and strict deadline environment 10) Excellent interpersonal skills 11) Strong leadership and management skills 12) Ability to handle multiple projects simultaneously and manage multi-functional teams 13) Creative problem-solving skills 14) Ability to work with office equipment and software like MS Office (MS Word, Excel and PowerPoint) 15) Ability to work independently 16) Excellent communication skills (verbal and written)