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Senior Medical Director, Clinical Development
3 months ago
Nimbus has an outstanding opportunity for a Senior Medical Director, Clinical Development to join our team. This person will serve as the primary Medical Monitor on a first–in–human study, establishing all the relevant relationships with site staff, CRO and relevant vendors. They are responsible for the safety of clinical trial participants throughout the study, including chairing dose escalation decisions, review and interpretation of data and provide clinical leadership to a cross–functional team at Nimbus. You will report to our Senior Vice President, Oncology Development.
In This Role You Will:
Lead the design, execution, and analysis of early–to–mid phase Oncology / Immuno–Oncology studies.Provide subject matter expertise and develop clinical strategy with cross–functional project teams (both preclinical and clinical), including input into all aspects of the integrated development plan.Serve as medical monitor and representative to multiple vendors and collaborators including CROs, PIs, and core laboratories, ensuring patient safety and data integrity.Support development and implementation of translational/biomarker plan to ensure successful implementation at study sites.Collaborate closely with internal research teams to integrate translational research and clinical strategies.Author clinical portions of regulatory submissions, safety reports, responses to regulatory authorities, and other documents as appropriate.Establish strong collaborations with study investigators, outside medical experts and represent Nimbus during investigator meetings and advisory boards.Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).Ensure scientific rigor and innovation is integrated into and drives Company's development strategies.Contribute to the development of strategic initiatives, specific Business Development activities, and various organizational initiatives in Clinical Development.These Qualifications Will Help This Role Be Successful:
MD or MD/PhD with 5+ years of relevant experience in biopharmaceutical industry, including early phase (FIH) drug development experience within Oncology therapeutic area. Immuno–Oncology experience preferred but not required.Broad understanding of biopharmaceutical drug development, including working knowledge of relevant ICH and GCP guidelines and regulations.Passion and proficiency in developing and nurturing key partnerships and collaborations with external parties, including investigators, KOLs, CROs, and the broader scientific community (including academia, governmental, or nonprofit organizations), as well as internal discovery and preclinical functions.Record of significant and successful contributions to regulatory submissions, including INDs/CTAs, and regulatory agency interactions.Experience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations.Aptitude and interest in serving as a subject matter expert within the organization.Excellent written and oral communication skills; experience delivering effective presentations to both technical and non–technical audiences.Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams.Ability to navigate, problem–solve, execute, and lead in a dynamic, fast–paced and evolving environment.A Snapshot of Nimbus
Our Science
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.
Our Culture
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.
Our Company
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Boston, Massachusetts. Learn more about us by going to .
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.
