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location: Lexington, Massachusetts
job type: Contract
salary: $126.40 - 148.70 per hour
work hours: 9 to 5
Provide medical and scientific support within clinical development for products within assigned therapy area (Rare Diseases - CMV infection post-transplant). Ensure that regulatory authority requirements, stakeholder requirements, and quality standards are met.
- Review data generated in phase III trials, oversight of CRO medical monitoring and safety coding for client sponsored clinical research programs.
- Collaborates with Global Clinical Development Lead, Clinical Scientists, Global Program Lead, Business Unit Leaders, Clinical Operations to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent
- Provides scientific advice within the client R&D and in support of brands and product launches. Interacts with clinical development 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 clinical programs.
- Reviews clinical protocols and clinical study reports for scientific and medical accuracy.
- Demonstrates expertise in data review and interpretation of phase III trials to deliver meaningful efficacy and safety conclusions.
- Demonstrates the ability to interpret conclusions in context of product profiles and medical practice.
- M.D. degree; 3 years minimum clinical development experience
- Demonstrated experience in conducting Phase III clinical trials and ability to collaborate in a matrixed environment. Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities preferred.
- Therapeutic expertise (Infectious Disease or Transplant) preferred but not required.
- Demonstrated in-depth understanding of drug development and working knowledge of regulations relating to drug development.
- Demonstrated ability to communicate and plan effectively with other client departments and to respond to inquiries or complaints from CRO and/or investigators.
- Strong judgment and decision-making skills with the willingness to roll up sleeves to assist the team to achieve its goals.
skills: IND, NDA, Maa, Regulatory Affairs Operations, 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.