- 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.
location: Cambridge, Massachusetts
job type: Contract
salary: $125.00 - 136.72 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
- Review data generated in phase III trials, oversight of CRO medical monitoring
and safety coding for company 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 company 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.
qualifications:
- 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.
- 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 company 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: Phase iii, Infectious Diseases, Investigational New Drug (IND), New Drug Application (NDA), Marketing Authorization Application (MAA), FDA 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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
