This listing was posted on Bevov.
Director of Clinical Development (Remote)
Location:
Seattle, WA
Description:
Job Description Our clientis on a mission to prevent and reverse chronic diseases and is a high-growth biotech startup that applies AI and machine learning to biological data, e.g., microbiome, transcriptome, and metabolome data, to provide direct-to-consumer personalized dietary and lifestyle recommendations for healthier living. They are a small, fast-growing, interdisciplinary team of passionate experts in biochemistry, microbiology, medicine, artificial intelligence, and machine learning with a shared mission to make illness optional. Lead investors include Khosla Ventures, West River Group, and Bold Capital Partners.As Clinical Director, you will be providing input on our clients clinical and strategic issues that impact the success of our Health Science Strategy.This is a full-time position located at our offices in the Seattle area (Bellevue and Bothell, WA). Responsibilities Provide scientific input during protocol development, oversight of study conduct, and interpretation of study results consistent with objectives to define safety,efficacy, patient-reported outcomes, and applicability of data to the targeted patient population.Lead a clinical research coordination team, ensure patient safety, that study objectives fulfill regulatory and reporting requirementsEngage and influence a diverse scientific community of internal and external experts, includingcollaborations.Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the studyLead and contribute to the end-to-end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into strategic and operational decisions.Integrate data from internal, and external academic, conference and competitor sourcesInteract with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc.Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical study/Clinical Development planEnsure the high quality of protocol documents are developed aligned to the clinical development planAuthor the Clinical Study Proposal, prepares and presents the study at Protocol Review Forum, incorporates any changes suggested post-governance meetingsProvide input into and reviews other relevant study documents including but not limited to, the informed consent (ICF), and study reference manual (SRM)Contribute to all regulatory reporting requirements and ensure prompt, quality responses to Institutional Review Boards /Ethics Review Committees, Independent Data Monitoring CommitteesPresents the scientific rationale and study design at Investigator Meetings and responds to scientific questions arising from sites during study conduct Qualifications Medicine degree with 8+ years of experience and understanding of clinical development from early-stage through to regulatory submission and market support with matrix management experienceExperience with data review/interpretation, study design, protocol authoring, amendmentsClinical development plan management experienceExperience authoring and/or collaborating on IBs, clinical study proposals, informed consent, and study manualsExperience presenting or preparing PRFs protocol review forumsKnowledge of regulatory requirements to support registration; generates processes/plans and/or provides clinical input into briefing documents to support regulatoryinteractions/approvalsand active attendance at IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, AdCom meetingsAdvanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes. Thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.Demonstrated experience leading in both matrix and line environment to deliver projects, and manage change Benefits Our Client Benefits Include Health insurance, Dental insurance, Vision insurance, Paid time off, Parental leave, Employee Assistance Program, Long- and Short-Term Disability, Waiting time may apply to benefitsOur client is a 150+ person start-up offering a successful commercial product that has generated high demand and is building out a vision to offer FDA-approved diagnostics and therapeutics to patients. With offices in Washington and New York, we are looking to hire team members capable of working in dynamic environments, who have a positive attitude and enjoy collaboration. If you have the skills and are excited about our clients mission, wed love to hear from you anddoes not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
Company:
Bevov
Posted:
April 19 on Bevov
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More About this Listing: Director of Clinical Development (Remote)
Director of Clinical Development (Remote) is a Executive Director Job at Bevov located in Seattle WA. Find other listings like Director of Clinical Development (Remote) by searching Oodle for Executive Director Jobs.
Director of Clinical Development (Remote) is a Executive Director Job at Bevov located in Seattle WA. Find other listings like Director of Clinical Development (Remote) by searching Oodle for Executive Director Jobs.