Ra Pharmaceuticals (NASDAQ RARX), a clinical-stage biopharmaceutical company based in Cambridge MA, is focused on the discovery, development and commercialization of novel therapeutics based on its proprietary peptide chemistry platform. Ra is developing therapeutics to treat serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system. Ra Pharmaceuticals is assembling a team of highly motivated and experienced professionals who are committed to improving the lives of patients and building a world class biotechnology company.
We are currently seeking a Director/Senior Director of Clinical Pharmacology to lead the development and execution of clinical pharmacology plans that characterize the pharmacokinetic (PK) and pharmacodynamics (PD) properties and drug-exposure relationships of candidate molecules. By integrating PK, PD, pharmacogenetic, demographic and disease knowledge, the individual will be critical in optimizing and driving insightful drug development plans in support of Ra's novel small molecule and peptide therapies. Primary responsibilities will include development of program-specific clinical pharmacology strategy, analysis and interpretation of PK/PD data, and modeling and simulation in support of a rapidly growing portfolio. Candidates should be self-motivated with experience working and leading in a highly collaborative cross-functional environment.
Support the development of novel therapeutic agents from early phase to late phase, regulatory submission, and beyond via characterizing PK and integrating knowledge in PK/PD/efficacy/safety to select the right dose and dose regimen for the general population and subpopulations.
Provide expertise and know-how in designing and implementing clinical pharmacology strategy in clinical trials during all clinical phases
Interact with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to clinical pharmacology and drug development
Address and resolve scientific issues arising in drug discovery/development programs.
Ph.D., PharmD, or M.D. in pharmacokinetics, biopharmaceutics, pharmacology, or a related discipline and a minimum of 5-7 years of industry experience.
Extensive knowledge of the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation and reporting is a prerequisite.
The successful applicant should have experience in providing input on clinical pharmacology plans and the preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
Hands-on experience with modeling and application of quantitative clinical pharmacology including pharmacometrics and other model-based approaches to guide drug development is required.
Experience working on the development of both small molecules and biologics is highly desirable.
Able to solve technical problems with enthusiasm in a team environment
Good written and oral communication skills
Ability to thrive and develop in a biotechnology culture