The Senior/Executive Director of Clinical Development for Gastroenterology will be responsible for the development and implementation of small molecule clinical programs in the therapeutic areas of immunology/inflammation at Nimbus, with an emphasis on gastroenterology indications. We are seeking a highly motivated, collaborative, results-oriented individual with the creativity, resourcefulness, and flexibility to excel in a growing company.
This individual will:
- Drive and/or oversee the design, execution, analysis, interpretation, and reporting of clinical studies, both early and more advanced, in a matrixed and highly collaborative team environment; emphasis will be placed on gastroenterology indications.
- Develop programmatic clinical strategy and plans together with the cross-functional project (asset) team, including input into all aspects of the integrated development plan
- Ensure patient safety and data integrity by serving as a medical monitor for clinical studies or hiring appropriate resources to serve as medical monitors for clinical studies
- Support development and implementation of translational/biomarker plan and help ensure successful implementation at study site(s)
- Lead/author clinical portions of regulatory submissions and responses to regulatory agency questions
The Qualifications We Are Seeking
- 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 and gastroenterology clinical development
- Prior experience as a functional leader (e.g., early clinical development, clinical pharmacology, experimental medicine, clinical development);
- 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 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.