Clinical Research Scientist
Role & Responsibilities
Reporting to our 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.
More specifically, the person in this role will:
- 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
These Qualifications Will Make This Role Successful
- 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
A Snapshot of Nimbus
Nimbus is a ~ 40 person, biotechnology company located in the thriving biotech hub of Cambridge, Massachusetts. We transform drug development by integrating computational drug discovery techniques, a cutting-edge computational chemistry platform and other advanced technologies to design breakthrough medicines for patients.
We focus on promising targets in metabolic disease, oncology and inflammation. These include both emerging and well-validated targets that have proven intractable to others in the pharmaceutical and biotechnology industry.
Nimbus offers a fast-paced, entrepreneurial, team-focused work environment. The culture is intellectually stimulating, flexible and results-oriented. Joining our Team offers significant opportunities to grow professionally and personally.
We also offer a top-notch benefits package (health, dental, life, vacation, and employer 401K contribution). Being part of Nimbus (a Nimbi, if you’re curious), allows you to become part of a small close-knit professional team that strives to bring out the best in each other by working hard and having fun together (company lunches and outings, running, rocking and even bowling from time to time!)
Join Nimbus. We are making a difference and you can too.
Nimbus is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.