We are seeking a highly motivated Principal Scientist/Senior Principal Scientist specialized in the identification and structural elucidation of metabolites. S/he will work in our drug discovery and development project teams with the goal of developing therapeutics to overcome resistance in cancer. The primary responsibilities will be to identify metabolites and profile the metabolic pathways of drug candidates, with an added opportunity of establishing a biotransformation strategy within ORIC. S/he will thrive in its partnership with discovery and development teams to identify clinical candidates and to support Regulatory filings. S/he is expected to independently plan and execute experiments, interpret results and troubleshoot problems. S/he will also provide preclinical expertise, including but not limited to those listed below.
Responsibilities:
- Identification and structural elucidation of metabolites through design, conduct and interpretation of in vitro and/or in vivo experiments using mass spectrometry, NMR and other structural elucidation tools
- Conduct in vitro drug metabolism studies to understand metabolic pathway as well as to identify reactive metabolites
- Utilize experimental and in silico data, along with expert opinions associated with drug metabolism, enzymology, enzyme kinetics and drug properties, to guide projects at all stages of drug discovery and development
- Establish strategy around biotransformation in drug research and development, while exploring new technology and methods
- Hands on experience in operation, troubleshooting, maintenance of H/UPLC, mass spectrometer and other instruments; maintain service contracts
- Participate and contribute to project team meetings and presentations; represent the department as the subject matter expert on DMPK
- Help junior scientists with lab and assay related issues including method and instrumentation
- Co-author high quality Regulatory documents including IND, CTA and NDA filings; assist in the preparation of DMPK components of nonclinical and clinical study protocol designs, nonclinical and clinical study reports, and investigator brochures
- Participate in the preparation of abstracts and manuscripts for publication
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations
Qualifications & Experience:
- Ph.D. in Drug Metabolism, Chemistry, Pharmacokinetics, Pharmaceutical Sciences or other relevant field with 7+ years, or with M. S. degree with 15+ years of experience or with B.S. with 20+ years of experience in the biopharmaceutical industry, with good understanding of ADME concepts; experience in clinical drug development is preferred
- Scientific and technical knowledge around drug metabolism, including enzymology and enzyme kinetics, is a must
- Expertise and extensive experience in profiling metabolism, including design, conduct and interpretation of data, is a must. Experience and knowledge with regulatory requirements of clinical metabolism such as MIST is preferred
- Experience with H/UPLC and mass spectrometry is a must
- Manage collaborations with CROs for outsourcing activities is preferred
- Excellent interpersonal skills and ability to represent DMPK in cross functional project teams
- Excellent oral and written communication skills
- A strong fit with ORIC’s culture and core values of commitment to excellence, patient-centered and collaboration
ORIC Pharma is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, national or ethnic origin, age, religion, disability, sexual orientation, gender, gender identity and expression, marital status, and any other characteristic protected under applicable State or Federal laws and regulations.