NEW!!clinical pharmacology role with a biotech in the bay area. Very exciting work and science, whomever takes this role will be the head of clin pharm and eventually grow the group. Level is flexible between AD/Dir/Sr. Director, please let me know if you would like to discuss or have a referral.
The head of clinical pharmacology will develop biologics with novel molecular formats to engage and activate immune cells for the treatment of cancer and other diseases. With multiple programs in clinical trials, we are recruiting a highly motivated scientist to head the critical function of clinical pharmacology. To support the advancement of the Company's clinical pipeline, the successful candidate will be the leader in building the department of clinical pharmacology. Responsibilities * Lead the Company's clinical pharmacology group. * Act as the subject matter expert and a key stakeholder in product development teams (PDTs); collaborate across functional groups to advance the Company's late stage research and clinical programs. * Recruit junior clinical pharmacologists and provide adequate support for drug development programs. * Apply state-of-the-art quantitative) methods in modeling and simulation based on nonclinical data and evolving clinical data. * Develop strategies and direct efforts in clinical pharmacology to meet regulatory requirements as development molecules move through advancing phases of clinical trials. * Manage CRO's and vendors to implement and validate methods, manage sample analysis, develop data transfer plans, organize and interpret data, and present analysis to key stakeholders (PDTs, senior management, and board of directors). * Present findings in the forms of scientific meeting abstracts, posters, and manuscripts. * Author documents for regulatory submissions. Qualifications * A PhD with 6-15 years of experience in clinical pharmacology modeling and simulation in the biotech/pharmaceutical industry. * Demonstrated experience, proficiency, and track record in running and/or overseeing clinical pharmacology programs in clinical trials. * Manage QSP work being done by vendors * Excellent communication skills, especially the ability to explain complicated principles of QSP and biologic meaning of modeling/simulation to lay audience. * Well-informed in regulatory guidance, requirements, and expectations in the US and internationally. * Knowledgeable in the significance and relevance of common clinical pathology and hematology endpoints to the pharmacological effects of cancer therapeutic agents. * Previous experience in biologics and working knowledge in the human immune system and lymphocyte functions relative to development of immuno-oncology drugs are major pluses. [cid:[email protected]] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 720-328-9526 - Office 315-415-4353 - Mobile (preferred) 720-475-1176 - Fax [cid:[email protected]] <https://www.linkedin.com/in/brenda-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=true>
