Director, Clinical Pharmacology
Nimbus has an outstanding opportunity for an exceptional Director of Clinical Pharmacology to join our team. This role will be responsible for all aspects of the clinical pharmacology strategy including early (Phase 1) and late-stage development (Phase 2/3 and NDA filings). This individual will provide strategic leadership and execution of clinical development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics, and drug metabolism of the drug candidate in selected preclinical and all clinical areas. This role will report to our Head of DMPK.
In this role, you will:
- Develop clinical pharmacology plans to support the development and registration of Nimbus products
- Be responsible for protocol design of clinical pharmacology trials, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans
- Provide strategic quantitative clinical pharmacology input to cross functional clinical development teams
- Determine scope, design, and planning and analysis of early and mid-stage pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations required from a drug development and regulatory perspective to take a project from concept to NDA submission
- Lead and prepare appropriate documents or sections of clinical protocols, clinical study reports with respect to Clinical Pharmacology studies or data
- Author regulatory documents (IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquires related to DMPK, PK/PD, and clinical pharmacology
- Oversee clinical study conduct and collaborate with leaders across all functions
- Monitor work with CROs and other external vendors to ensure compliance with agreed protocols, quality standards and timelines
- Review external data, lead analysis, interpretation and reporting of clinical pharmacokinetic and pharmacodynamic data
- Manage bioanalysis and PK activities at CROs and other external vendors
These qualifications will help this role be successful:
- PhD, PharmD or equivalent training in Clinical Pharmacology, Pharmacokinetics, or a related field with 7+ years of biotech or pharmaceutical industry experience as a clinical pharmacologist with proven understanding of drug development
- Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission
- Demonstrated track record and ability to manage the clinical pharmacology / pharmacokinetic components of development projects
- Experienced in performing Modeling and Simulation (M&S) in drug development (ie. PK/PD, PBPK, mechanistic modeling, population PK) (preferred)
- Proficiency and experience in using common PK / PD modeling software packages (i.e., Phoenix WinNonlin, NONMEM, R, SAS, and other similar tools)
- Excellent project management skills
- 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
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.