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Job Posting: Director for Medical Affairs at Global Clinical Research Organization, Salary up to 220K
Director, Medical Affairs
Date Posted: 8/12/2008
Job Id: 1637
Company: We are a leading global clinical research organization (CRO). We have proven proficiency in supporting worldwide clinical trials for medical device, pharmaceutical and biotechnology companies. We have an influential focus in the areas of Cardiovascular Diseases, Oncology and Medical Devices. We are devoted to providing clients with crucial thinking, customer service and quality deliverables. We are committed to making sure that each clinical trial is performed to the highest possible standards.
Location: Massachusetts
Reports To: CMO
Salary: Commensurate with experience up to 220k
Education: Medical Degree (MD)
Requirements: 5-7 years industry experience including and at least 3 years clinical trial experience; minimum 5 of industry experience and/or clinical trial experience with drugs, devices or biologics. Medical license required. Board certification preferred. Management experience is preferred. Excellent organizational skills with ability to work in a high volume and strict deadline environment. Proficiency in operating computers applications and navigating the internet. Excellent interpersonal skills. Excellent verbal and written communications skills. Ability to work independently Strong leadership and management skills. Ability to handle multiple projects simultaneously and manages multi-functional teams; must have creative problem solving skills; excellent verbal / written communication skills. Excellent time management and organizational skills. Excellent knowledge of the drug development process. Preferred Qualifications Experience with clinical development plans of new chemical entities, biological products and devices, experience working with or for a CRO. Experience with CDER, CBER, CDRH and international regulatory agencies is a plus.
Duties: POSITION SUMMARY: Provide leadership and supervision with a Cardiovascular or Device focus within the Medical Affairs group. T
he Medical Director will have responsibility for successful clinical input and medical monitoring for multiple clients, guidance and support to project teams, interface with Sponsors and Regulatory authorities, provide training to in-house staff on protocols and therapeutic areas, work with Sponsors and Medical Affairs group in protocol development and/or review, interact with Clinical Safety department and Investigators regarding pharmacovigilance and study implementation. Provide direct and supportive medical services to multiple clients, including the following: Interact with the Sponsor in protocol review or development. Perform literature analysis of therapeutic area involved in Sponsor clinical development. Manage all aspects of medical monitoring specifically focusing on Cardiovascular or Device inclusive of patient eligibility, protocol deviations, and protocol interpretation. Work in matrix environment with Clinical Affairs (Project Managers, Lead CRAs, etc), Data Management and Biometrics. Create team structures including a defined decision-making process that supports objectives and meets timelines. Communication with clients and Client Project Managers to promote project schedule adherence, ensure that projects are adequately staffed with personnel and resources, and meet high quality standards. Provide guidance on medical and scientific issues, interact with principal investigators and opinion leaders. Development and maintenance of work guidelines, department metrics and project tools. Coordinate training and education programs to ensure staff is trained as needed, including but not limited to relevant therapeutic areas, ICH guidelines, and regulatory requirements. Collaborate with staff inter- and intra-departmentally on the proposal development process. Make presentations and represent Company at professional meetings and with prospective and existing clients. Participate in business development presentations as required. Manage personnel activities, and provide guidance for professional development of staff (coordinate resource distribution across projects, interviews, makes hiring recommendations, leads disciplinary actions, delivers performance reviews) with a focus in therapeutic expertise. Other duties may be assigned. Additional Duties and Responsibilities: Participate in staffing the Company exhibit booth at medical conferences. Participate in business development visits to current and potential clients. Contribute to scientific publications by reviewing for scientific accuracy, content, consistency and conclusions. Collaborate with business development in review, writing, presentation and defense proposals. Perform all other duties as assigned.
IF INTERESTED, PLEASE CONTACT:
andrewy@keyrecruit.com
Andrew Youngelson
Key Recruit Inc.
www.keyrecruit.com
Date Posted: 8/12/2008
Job Id: 1637
Company: We are a leading global clinical research organization (CRO). We have proven proficiency in supporting worldwide clinical trials for medical device, pharmaceutical and biotechnology companies. We have an influential focus in the areas of Cardiovascular Diseases, Oncology and Medical Devices. We are devoted to providing clients with crucial thinking, customer service and quality deliverables. We are committed to making sure that each clinical trial is performed to the highest possible standards.
Location: Massachusetts
Reports To: CMO
Salary: Commensurate with experience up to 220k
Education: Medical Degree (MD)
Requirements: 5-7 years industry experience including and at least 3 years clinical trial experience; minimum 5 of industry experience and/or clinical trial experience with drugs, devices or biologics. Medical license required. Board certification preferred. Management experience is preferred. Excellent organizational skills with ability to work in a high volume and strict deadline environment. Proficiency in operating computers applications and navigating the internet. Excellent interpersonal skills. Excellent verbal and written communications skills. Ability to work independently Strong leadership and management skills. Ability to handle multiple projects simultaneously and manages multi-functional teams; must have creative problem solving skills; excellent verbal / written communication skills. Excellent time management and organizational skills. Excellent knowledge of the drug development process. Preferred Qualifications Experience with clinical development plans of new chemical entities, biological products and devices, experience working with or for a CRO. Experience with CDER, CBER, CDRH and international regulatory agencies is a plus.
Duties: POSITION SUMMARY: Provide leadership and supervision with a Cardiovascular or Device focus within the Medical Affairs group. T
he Medical Director will have responsibility for successful clinical input and medical monitoring for multiple clients, guidance and support to project teams, interface with Sponsors and Regulatory authorities, provide training to in-house staff on protocols and therapeutic areas, work with Sponsors and Medical Affairs group in protocol development and/or review, interact with Clinical Safety department and Investigators regarding pharmacovigilance and study implementation. Provide direct and supportive medical services to multiple clients, including the following: Interact with the Sponsor in protocol review or development. Perform literature analysis of therapeutic area involved in Sponsor clinical development. Manage all aspects of medical monitoring specifically focusing on Cardiovascular or Device inclusive of patient eligibility, protocol deviations, and protocol interpretation. Work in matrix environment with Clinical Affairs (Project Managers, Lead CRAs, etc), Data Management and Biometrics. Create team structures including a defined decision-making process that supports objectives and meets timelines. Communication with clients and Client Project Managers to promote project schedule adherence, ensure that projects are adequately staffed with personnel and resources, and meet high quality standards. Provide guidance on medical and scientific issues, interact with principal investigators and opinion leaders. Development and maintenance of work guidelines, department metrics and project tools. Coordinate training and education programs to ensure staff is trained as needed, including but not limited to relevant therapeutic areas, ICH guidelines, and regulatory requirements. Collaborate with staff inter- and intra-departmentally on the proposal development process. Make presentations and represent Company at professional meetings and with prospective and existing clients. Participate in business development presentations as required. Manage personnel activities, and provide guidance for professional development of staff (coordinate resource distribution across projects, interviews, makes hiring recommendations, leads disciplinary actions, delivers performance reviews) with a focus in therapeutic expertise. Other duties may be assigned. Additional Duties and Responsibilities: Participate in staffing the Company exhibit booth at medical conferences. Participate in business development visits to current and potential clients. Contribute to scientific publications by reviewing for scientific accuracy, content, consistency and conclusions. Collaborate with business development in review, writing, presentation and defense proposals. Perform all other duties as assigned.
IF INTERESTED, PLEASE CONTACT:
andrewy@keyrecruit.com
Andrew Youngelson
Key Recruit Inc.
www.keyrecruit.com
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