Whole Biome is an early-stage, venture-backed biotech located in San Francisco. We are a small team of scientists, engineers and physicians interested in improving human health by using the latest research from diverse fields, such as, microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition sciences.
We are currently seeking a Clinical Scientist to join Whole Biome’s Clinical Team. As Clinical Scientist you work directly with the Chief Medical Officer in study design, study planning, preparation, management, evaluation, and documentation. You will lead the full protocol development and will directly interact with the study team and clinics. You will also provide clinical scientific input for final study reports and annual report documentation, and assist in documentation processes including communications with IRBs. Additionally, you will have the opportunity to work with the Manufacturing, Molecular Biology, and Compute Teams to support and enable the discovery and development of novel, life-changing microbiome interventions.The successful candidate will be able to learn new systems quickly and adapt to changing needs as Whole Biome rapidly expands capabilities in terms of projects and processes. The successful candidate will be excited and able to travel and be the face of Whole Biome for partnering clinicians and trial sites.
Lead and matrix manage the multi-site, multidisciplinary clinical trials team to ensure all trial deliverables are met.
Lead clinic design meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to the executive team.
Serve as the primary point of contact for clinics, supporting their needs, answering questions, and reporting summaries to the internal team. Suggest internal development when needed.
Work with Chief Medical Officer to refine clinical trial design(s), identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings.
Interact with investigator sites and CRAs/CROs/clinical labs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, site monitoring visits, protocol deviations and maintaining awareness of issues raised.
Co-author the Clinical Study Protocols, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.
In collaboration with the internal analysis team and clinic sites, manage the ongoing medical/ scientific review of the clinical trial data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with the Chief Medical Officer, Data Analyst, Statistician, and third parties to ensure high quality data are transferred/available in a timely manner.
Identify areas for process or technology improvements.
Maintain knowledge of regulations and procedures for clinical trials.
REQUIREMENTS: This is a dynamic, start-up environment that requires an individual with adaptability, ingenuity, independent drive, and a passion for improving patient care.
PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences.
Experience in designing, planning and implementing clinical trials, ideally in patients with metabolic syndrome.
Knowledge and experience with Good Clinical Practice standards
Knowledge of digital health diagnostic tests and successful implementation.
Demonstrated ability to work independently and be a fully contributing member of a multi-functional fast-paced team environment.
Experience in implementing and prioritizing work across multiple projects under tight time constraints.
Desired experience with running clinical trial to test product efficacy (therapeutic or diagnostic).
Effective, concise and proactive communicator.
Whole Biome is developing novel classes of therapeutics and diagnostics that target the human microbiome to improve the lives of patients suffering from a variety of diseases. At Whole Biome, we employ cutting-edge technology in our R&D pipeline. We are passionate about building products that are best-in-class and we are looking for individuals who embody that same desire.
At Whole Biome, we understand that success means building great teams to solve challenging problems. We hire the best and brightest and give everyone the resources we need to succeed.
Benefits: - competitive salary and equity packages - health, dental, and vision - 401k with corporate matching - flexible schedules with a focus on work/life balance - unlimited vacation policy (we're all adults and professionals, not clockwatchers) - commuter benefits
Sweet Perks - casual culture (66% of founders usually wearing hoodies) - artisanal coffee - on-site gym - strong belief in work/life balance; we believe it, we encourage it, we live it - pick your own laptop - collaborative, team environment - off-site, team building adventures - walking distance to Caltrain, Muni - walking distance to bars and restaurants in Dogpatch
If you're someone who thrives in a fast-paced environment where autonomy and collaborative teams are equally valued, AND you are excited to dedicate your life to improving health, please get in touch with us! Email email@example.com with your resume and cover letter to begin the application process. Even if you don't see an opening that fits you, please send us your resume if you think your background and personality would be a great fit!