Senior Director, Clinical Development (MD) - Immunology
The Senior Director of Clinical Development will be responsible for the development and implementation of small molecule clinical programs in the therapeutic area of immunology at Nimbus. We are seeking a highly motivated, collaborative, results-oriented individual with the creativity, resourcefulness, and flexibility to excel in a growing company. This role will report to the Senior Vice President of Clinical Development.
In this role, you will:
- Drive and oversee the design, execution, analysis, interpretation, and reporting of clinical studies, both early and more advanced, in the area of immunology, in a matrixed and highly collaborative team environment
- Develop programmatic clinical strategy together with cross-functional project teams (both preclinical and clinical), including input into all aspects of the integrated development plan. If appropriate, serve as the program lead responsible for end-to-end delivery of projects in or nearing clinic
- Lead/author clinical portions of regulatory submissions and responses to regulatory agency questions
- Ensure patient safety and data integrity by providing or contracting for excellent medical monitoring for clinical studies
- Support development and implementation of translational/biomarker plan and help ensure successful implementation at study site(s)
These Qualifications Will Help This Role Be Successful:
- M.D. or M.D., Ph.D. with a minimum of 5 years of relevant experience in biopharmaceutical industry, including significant small molecule drug development experience within Immunology therapeutic area
- 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 across the organization
- Excellent written and oral communication skills; experience delivering effective presentations to both technical and non-technical audiences
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 Boston, 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.