Medical Advisor Associate Director Job Listing at Genzyme Corporation in Cambridge, MA
Medical Advisor - Associate Director-30336
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent ground breaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
This role is key for medical supervision and medical management of clinical trials in the North American Region (US Canada). The Medical Advisor (MA) is the medical link between Medical Operations (and/or Units/Customers) and (potential) investigators or experts/Key Opinion Leaders (KOL's) in North American Region. He/she should be the medical support in the territory for the studies he/she is allocated to. He/she should provide appropriate medical feed back to central clinical trial team especially to Clinical Study Director (CSD) and Feasibility Manager (FM)
- Conduct pre feasibility and/or assess the feasibility of international protocols in the North American Region by collecting information and documentation on the study to be performed and by conducting surveys with opinion leaders, experts or potential investigators as Health Authorities according to Clinical Study Director (CSD) and Feasibility Manager (FM) (Medical Operations) requirements and timing.
- Serve as "Medical" liaison and ensure appropriate collaboration with the Global team (CSD, FM…) Serve as first-line medical support to the CRU team e.g.: answer medical questions from investigating sites, Ethics Committees, monitoring teams (MTs), study managers. Conduct appropriate review of patients' data (e.g. patient profiles, e-CRF data,…) especially for critical cases (outcome events, related SAEs, AEs with pre-specified monitoring,…) in order to support MT and CSO and get data quality.
- Provide expert scientific advice and leadership while managing a broad range of activities associated with the assigned product(s) and therapeutic area (s).
- Responsible for local scientific knowledge and lobbying allowing capture of country specific information on competitive ingelligence and validation of global hypothesis from the Clinical DEvelopment Plan or assessment of Extended Synopsis (ES)/ protocol contents
- CRU preferred point of contact for Medical Operations to review and to provide medical input on proposed ES, protocol and/or Clinical Development Plan and medical practices in North American Region.
- Promote participation of the North American Region for any clinical study and maintain and expand the investigator network across Region; ensure quality of local/regional Investigator Meetings regarding medical content, ethics and interaction with investigators
- Maintain a network of experts and potential investigators within his/her therapeutic field and region; identify potential investigator's site competence and their capacity to respect the trial commitments; approve site selection
- Support the affiliates network of Key Opinion Leaders (KOL) and experts when selecting national Coordinators or members of Study Committees.
- Ensure medical and scientific training to the monitoring team and others (including a good understanding of material provided by the Global team (e.g: Firecrest modules…).
- Contribute to the exchange of relevant information between RD and Medico marketing department regarding clinical activity of the CRU and support the handover of RD products to marketed compounds.
- Ensure all activities under his/her direction comply with Clinical Development Standard Operating Procedures (SOP's), Good Clinical Practices and US and Canadian Regulations.
- Medical Degree
- 3 plus years experience in Clinical Development or Clinical Research
Knowledge And Skills Desirable But Not Essential:
- Ability to speak English, French and Spanish
- Qualification in a medical specialization (Oncology) strongly preferred
- Understanding of country specific medical guidelines in area of responsibility to allow for development of appropriate strategies M*
Job : Clinical
Primary Location : United States-Massachusetts-Cambridge
Job Posting : May 15, 2013
Shift : Day Job
Job Type : Regular
Employee Status : Regular
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