Director, Clinical Operations
The mission of the Biotechnology startup Earli Inc. is large and ambitious: to detect and then cure cancer at its earliest stages, effortlessly and pain free. In other words, ‘make cancer a benign experience’. The technology which grounds the company’s efforts ushers in a new era in “synthetic biomarkers” as a novel methodology to detect cancer and then subsequently localize and then treat the cancer. The enabling technology utilizes “synthetic biomarkers” as a novel methodology to detect, localize and ultimately destroy cancer. Founded by Sam Gambhir, Cyriac Roeding and David Suhy, the company is well funded by world-class entrepreneurs and venture capital firms. Earli, Inc. is currently based in Redwood City, California.
Who You Are
- You share our same sense of dedication, scientific passion and entrepreneurial spirit
- You work well in a fast-paced and extremely focused startup environment
- You are not only smart, but clever and constantly think outside the box
- You are able to make logical decisions in an instant when there is little time to evaluate
- You are a natural communicator and relationship builder
- You stay calm under high pressure and stress
- You have the ability to multi-task in a serious way, with an extreme attention to detail
- You become a representative of the core DNA of the company through who you are
Earli, Inc. is currently seeking a dynamic individual who is inspired to change the world by pushing the scientific envelope. She/he will have the title of Director of Clinical Operations will be responsible for overseeing the implementation and execution of sponsored clinical trials within Earli within established timelines, budget and quality standards. This position will initially report to the Chief Scientific Officer.
Your Primary Responsibilities
- Provides strategic and technical guidance to ensure that clinical trials are properly defined, planned and executed. Leads and directs the clinical operations team responsible for management and execution of all clinical trials.
- Working in a matrix organization, ensures that study objectives are in line with the clinical development strategy and the overall corporate goals.
- Plays a lead role in managing the authoring and creation of key clinical documents (directly or through the involvement of clinical research organizations and/or external consultants) in support of new and ongoing development programs including: investigator brochures, clinical study protocols, informed consent forms, clinical study reports and associated summaries.
- Ensures that external vendors are selected and managed to deliver within established timelines and budget.
- Drives the ongoing creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
- As the company expands, will be responsible for leading and directing the building of department infrastructure from scratch, including developing, training, and retaining the clinical operations team
- Builds collaborative relationships with key company stakeholders as needed to support clinical programs.
- Collaborate with KOLs for feedback on study protocols and development plans.
- Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
Your Required Experience, Knowledge and Skills
- Minimum education: M.S. /B.S in life sciences, scientific or other relevant discipline.
- 10+ years of strong hands-on experience in the execution of Phase 1-3 clinical trial.
- Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
- In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Medical writing experience a plus
- Significant experience with effective project team leadership and management oversight
- Is a creative, analytical problem solver, who acts decisively, yet communicates the risks and benefits associated with all potential solutions so that informed business decisions can be made.
- Able to work across multiple functions and geographies (e.g., US and non-US).
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Strong interpersonal skills including verbal and written communication.
If interested in applying, please attach a CV or have a well-developed LinkedIn profile for us to be able to assess your background.
We look forward to hearing from you!