- Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates that support drug discovery, preclinical and clinical development
- Responsible for the analysis, interpretation, integration and reporting of preclinical DMPK data generated both internally and with external collaborators
- Represent DMPK as the subject matter expert to project teams
- Provide leadership and management support for nonclinical DMPK that can build and inspire our teams and drive collaboration and innovation
- Establish effective relationships with CROs, consultants, and internal team members to develop and qualify various analytical and bioanalytical methods.
- Design, contract and manage CRO in the conduct of in vitro / in vivo ADME studies. Review study protocols and reports, interpret and communicate results
- Prepare strategic and scientifically sophisticated ADME strategies that meet regulatory requirements and program goals
- Author, review and approve scientific reports that support regulatory documents including INDs, CTAs, and NDA filings.
- Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments
- Provide leadership and management support for nonclinical DMPK that can build and inspire our teams and drive collaboration and innovation
- PhD in Pharmacokinetics, Pharmacology, Pharmaceutical Science or other relevant field with 15+ years of experience in the biopharmaceutical industry
- Strong knowledge of small-molecule drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles
- Track record of success with clinical development phases
- Ability and Interest in leading dynamic, multi-disciplined project teams
- Prior experience with regulatory submission (e.g., IND, NDA and/or BLA) preferred
- Working knowledge in various modeling techniques and programing preferred
- Excellent verbal and written communication and organizational skills required with experience working on cross functional teams
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment
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Executive Director, DMPK - Boston, United States - Nimbus Therapeutics
Description
Nimbus has an outstanding opportunity for an exceptional Executive Director, DMPK to join our team. This role will serve as the function head, applying subject matter expertise in absorption, distribution, metabolism, and excretion (ADME), pharmacokinetics, and pharmacodynamics, along with effective team management skills, to drive the strategy and execution of our clinical development and pre-clinical programs. You will report to our Senior Vice President of Nonclinical Sciences.
In this role, you will:
These Qualifications Will Help This Role Be Successful:
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.