Nimbus has an outstanding opportunity for an 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 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 3 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