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location: Cambridge, Massachusetts
job type: Contract
salary: $70.07 - 82.44 per hour
work hours: 9 to 5
•Providing leadership and management within CD to provide medical and scientific support for products within assigned therapy area.
•Support development and execution of medical & clinical strategy for assigned company product(s).
•Oversight of study design and data generated, including clinical trial medical monitoring, from company-sponsored clinical research programs ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met.
•Collaborates with Global Development Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent; Provides scientific advice within company R&D and in support of brands and product launches.
•Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
•Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
•Provides expert Medical advice / leadership to the project teams for the development of Phase I- IV clinical programs.
•Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and medical accuracy.
•Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
•Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
•M.D. degree (required); Hematology training and certification (preferred).
•Experience working in bleeding disorders is highly preferred
•Generally has at least eight (8) years of experience in the Pharmaceutical Industry with relevant industry experience.
•Demonstrated ability to collaborate in a matrixed environment
•Experience in Submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or Experience in designing and conducting Phase II-III clinical trials; and/or
•Significant late-stage development research
•Therapeutic expertise (Hematology) preferred
•Demonstrated in-depth understanding of drug development and pharmaceutical marketing within non-malignant hematology
•Working knowledge of regulations relating to drug development and promotional activities
•Demonstrated ability to communicate and plan effectively with other company departments and to respond to inquiries or complaints from customers.
•Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization.
skills: IND, NDA, Maa, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.