Job Description
Our client is 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 client's 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 & 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 requirements
- Engage and influence a diverse scientific community of internal and external experts, including collaborations.
- Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study
- Lead 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 sources
- Interact 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 plan
- Ensure the high quality of protocol documents are developed aligned to the clinical development plan
- Author the Clinical Study Proposal, prepares and presents the study at Protocol Review Forum, incorporates any changes suggested post-governance meetings
- Provide 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 Committees
- Presents 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 & understanding of clinical development from early-stage through to regulatory submission and market support with matrix management experience
- Experience with data review/interpretation, study design, protocol authoring, amendments
- Clinical development plan management experience
- Experience authoring and/or collaborating on IBs, clinical study proposals, informed consent, and study manuals
- Experience presenting or preparing PRF’s – protocol review forums
- Knowledge of regulatory requirements to support registration; generates processes/plans and/or provides clinical input into briefing documents to support regulatory interactions/approvals and active attendance at IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, AdCom meetings
- Advanced 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 benefits
Our 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 client's mission, we’d love to hear from you and does 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.