The Company
My client is a biotechnology company based in Massachusetts. Their research focuses on metabolic disease, oncology and inflammation. They have an opportunity for a Clinical Research Scientist to join their team!
Role Summary:
Reporting to the VP, Early Clinical Development, the Clinical Research Scientist will be a key member of the Discovery team, supporting the activities associated with clinical studies. The person in this role will be responsible for designing, implementing, and undertaking clinical trials during the research process. They will coordinate with the other members of the research team and be responsible for liaising with the senior leadership team, outside vendors, and other clinical investigators.
Responsibilities:
- Review the scientific data and develop product knowledge to understand and communicate the relevant information for 1 or more clinical studies
- Develop and review various study protocols with minimal guidance including writing, reviewing, adjudication/resolution of cross functional comments, and ensuring a high quality final document
- Prepare and present the reports and presentations on the various findings of the clinical research
- Provide regular updates on the progress of the clinical research to the broader Discovery team, senior leadership team, and other relevant functions
- Regularly review the information to check safety procedures, efficiency, and the lab data accuracy and correctness
- Review and validate clinical study reports (CSRs) with a thorough understanding of the connection between the data and the CSR
- Contribute to, coordinate, and review regulatory documents, Consent Forms (ICF), and other relevant materials
- Collaborate with all study team members including Clinical, Clinical Operations, Drug Safety, Regulatory Affairs and CRO / external vendors
Requirements:
- Bachelor’s degree in life sciences or health-related field with an advanced degree such as a Masters, PharmD, PhD in biological / pharmaceutical science, or MD
- Experience across multiple therapeutic areas, including oncology and/or immunology/inflammation (preferred)
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Proficient in Medical Terminology and medical writing skills
- Knowledge on ICH, GCP, and other relevant regulatory guidelines
- Proven ability to analyze clinical information succinctly and efficiently with strong written communication – especially as it relates to developing clinical protocols, assessing the quality of data, and presenting trial results
- Excellent interpersonal and decision-making skills with demonstration of innovation, drive, energy and enthusiasm to deliver key objectives in a timely manner.
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment
- An outstanding track record of strong communication, presentation, analytic and strategic capabilities and ability to effectively collaborate with medical experts
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives