Senior Director, Clinical Research Science
Reporting to our VP, Early Clinical Development, the Senior Director of Clinical Research Science will be a key member of the Development team, supporting the activities associated with the design, execution, and reporting of clinical studies. They will coordinate with the other members of the Development team and be responsible for liaising with the senior leadership team, outside vendors, and external investigators. They will have influence into the overall way that the development team works, and may be responsible, depending on evolving business needs, for leading a team of clinical scientists.
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
- Contribute to, coordinate, and review regulatory documents, Consent Forms (ICF), and other relevant materials
- Provide regular updates on the progress of the clinical research to the broader Development team, senior leadership team, and other relevant functions
- Regularly review the information to check safety procedures, efficiency, and the lab data accuracy and correctness
- Prepare and present the reports and presentations on the various findings of the clinical research
- Collaborate with all study team members including Clinical, Clinical Operations, Drug Safety, Regulatory Affairs and CRO / external vendors
- Review and validate clinical study reports (CSRs) with a thorough understanding of the connection between the data and the CSR
- Contribute to abstracts and publications that evolve from clinical trial data
- Provide input into the appropriate resourcing and ways of working that promote “flawless execution” of complex trials undertaken with CROs
- Grow and lead, as business needs evolve, a team of clinical scientists who are directly tasked with the design, execution, and reporting of clinical trials
These Qualifications Will Make This Role Successful
- Bachelor’s degree in life science 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)
- Experience working with and proactively seeking input from a cross-functional development team through the design, execution, and reporting of clinical trials
- Experience leading/mentoring clinical scientists is desirable
- 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
At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we’ve built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.
Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Cambridge, Massachusetts. Learn more about us by going to www.nimbustx.com
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.