
Manage the budget for the Clinical Pharmacology, PK/PD and pharmacometrics studies and related activities. Contribute to the generation of company public disclosures including patent applications and IR documents. Identify and vet CROs, to conduct Sierra-sponsored preclinical studies related to Clinical Pharmacology. Significant contribution to the technical assessment of new drug asset search and discovery activities, in collaboration with Sierra’s senior BD leadership. Provide Clinical Pharmacology expertise and represent Sierra at global health authority meetings as needed. Contribute Clinical Pharmacology related content to regulatory documents (CTD, Investigator brochure (IB), EOP2 meetings, NDA/MAA)for submission to global health authorities. Contribute to the writing of study protocols, craft and review final reports for internal and external use organize data presentations and reports as needed. Work collaboratively with CRO’s/external vendors to ensure compliance with planned study protocols, internal Sierra quality standards and timelines. Lead the analysis, interpretation and reporting of data obtained from these Clinical Pharmacology, PK and related studies. Lead PK aspects of the company’s ongoing clinical programs including liaison with Sierra staff responsible for bioanalysis and clinical operations. ADVAN TRANS PK NONMEM REGISTRATION
assessment of QT, food effect, ADME, DDI strategy, special populations, etc.) and PK/PD and pharmacometrics to support development and rapid registration of Sierra’s products
Develop clinical pharmacology plans (e.g. Provide strategic clinical pharmacology and pharmacometrics guidance to cross functional project teams across the development programs of Sierra’s product pipeline and portfolio. Reporting to the Chief, Research and Early Development the Senior Director, Clinical Pharmacology is responsible for oversight and execution of the Clinical Pharmacology components of the development programs of Sierra’s product pipeline and portfolio., including Pharmacokinetics (PK), Pharmacodynamics (PD) and Pharmacometrics. Together we are transforming promise into patient impact. Our team takes an evidence-based approach to understand the limitations of current treatments and explore new ways to change the cancer treatment paradigm. We harness our deep scientific expertise to identify compounds that target the root cause of disease to advance targeted therapies with assets on the leading edge of cancer biology. Sierra Oncology is a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer. Interested in advancing your career surrounded by great colleagues?
We are led by a senior management team with a proven track record in research, clinical operations, product development, regulatory affairs and business development. We are looking for exceptional individuals who share our commitment to developing and commercializing targeted therapeutics to address serious unmet needs in oncology.
At Sierra Oncology we believe our employees are our greatest asset.