Director, Clinical Research Science (Oncology)
Nimbus Therapeutics has an outstanding opportunity for an exceptional Director of Clinical Research Science (Oncology) to join our team. This Director of Clinical Science will be responsible for performing and leading all clinical science activities for current and future Oncology programs, including but not limited to providing clinical science planning for Oncology studies, reviewing key product and study related documents, preparing protocol designs, monitoring and analyzing studies for emerging data trends, and contributing to the development of relevant clinical section regulatory correspondence and submissions. This role will report to our Senior Director, Clinical Research Science.
In This Role, You Will:
- Ensure relevance and accuracy of clinical science planning and guidance for relevant Oncology clinical studies (e.g., study concepts/synopsis, eligibility, database elements, protocol and product-related training, investigative site questions, literature benchmarks)
- Lead and review key product and study related documents and deliverables including study synopses, clinical protocols/amendments, study manuals, Investigator’s Brochures, informed consent forms, Case Report Forms, Clinical Study Reports, Annual Reports, Statistical Analysis Plans, Tables Listings and Figures, and regulatory submissions
- Work with investigative sites and/or study teams to answer protocol related questions and resolve study conduct issues
- Prepare and/or present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
- Review clinical data listings, patient profiles and summaries to ensure data collection proceeds in a manner consistent with the protocol and strategic objectives
- Assist in the monitoring and analysis of emerging data trends
- Provide support for review and summarizing safety and efficacy data in ongoing studies to internal and external stakeholders
- Support the development of clinical sections for regulatory correspondence and submissions, including but not limited to Information Requests, Meeting Information Packages and presentation materials, and IND/NDAs
- Support project team with conduct of clinical studies including clinical trials registration and results reporting, data management deliverables, clinical monitoring activities, interim analyses planning and Data Safety Monitoring Board or Steering Committee meetings as applicable
- Conduct literature reviews to support clinical development programs and regulatory submissions
- Participate in authoring and review of abstracts/publications and presentation
These Qualifications Will Help This Role Be Successful:
- Degree in scientific/life sciences/clinical/nursing field; advanced degree (MS, PharmD, PhD, MD) preferred
- Experience in clinical research, with at least five years as a Clinical Scientist required; experience with Oncology required
- Familiarity with clinical trial design and experience authoring clinical trial protocols
- Experience in analysis, interpretation, and presentation of clinical data in order to inform decision making and clinical strategy
- Experience working in a busy and highly collaborative environment as a part of a cross-functional team
- Excellent verbal and written communication skills
- Commitment to Nimbus Core Values and Essential Behaviors:
- Core Values: Integrity, Teamwork, Authentic Communication, Passion for Excellence
- Essential Behaviors: Roll Up Your Sleeves, Lean Into The Team, Elevate Your Perspective, Respectfully Challenge
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.
At Nimbus, we believe our diversity of backgrounds and experiences strengthens our community and our ability to design breakthrough medicines. We prioritize creating an inclusive, welcoming culture that promotes our core values and encourages every Nimbi to bring their whole selves to their work. Nimbus is proud to be an equal opportunity employer. We value and celebrate all our employees and recognize that our diversity and inclusion are keys to our success. Nimbus is committed to providing equal opportunity for all employees and applicants without regard to 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.