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Director of Clinical Operations

Organization
DotLab
Job Location
-
New Haven or San Francisco, CA -
United States
Salary
Negotiable based on experience
Job Description

We are looking for a Director of Clinical Operations to support the clinical development of our endometriosis test and pipeline products. The candidate will be required to provide project management and program oversight to plan and manage clinical trials in accordance with regulations and to support commercialization objectives and regulatory and payer needs.

RESPONSIBILITIES


-Responsible for the high quality conduct of all DotLab clinical trials across endometriosis test and pipeline products
-Collaborate with advisors, PIs, statisticians, regulatory consultants, and DotLab leadership to develop robust clinical trial protocols
-Facilitate all study startup activities, including identifying, qualifying, and auditing clinical trial sites and ensuring they are properly trained to comply with clinical study protocols and SOPs
-Develop required clinical study documentation in accordance with regulations (e.g., to seek IRB approvals, patient consent forms)
-Oversee and drive patient recruitment across study sites, including implementing recruitment programs as needed
-Proactively monitor trials by arranging regular site visits, ensuring compliance, and ensuring appropriate data collection
-Provide regular updates to key stakeholders regarding study progress (e.g., leadership, PIs, site staff) via formal and informal written communications and meetings
-Create and align with leadership on study project plans and manage resources and timelines accordingly
-Prepare and manage study budgets, negotiate budget agreements with trial sites, and oversee trial spending
-Oversee trial data management, including development of case report forms, managing EDC systems, developing data QC protocols, collecting required source documentation, and ensuring all queries have been closed prior to study completion
-Develop study closeout procedures and ensure they are appropriately followed
-Provide input in the development of post-study reports (e.g., publications, CSRs, presentations)

 

Requirements

-Bachelor's or Master's degree in relevant field 
-Experience running clinical trials for LDTs and IVDs 
-Superior knowledge of regulatory guidelines for the conduct of LDT and IVD clinical trials 
-Excellent project management skills, with an ability to manage multiple priorities, timelines, resources, and stakeholders 
- Experience working with CROs 
-Ability to work independently and drive clinical trials forward with minimal supervision 
-Knowledge of clinical study protocol development 
-Leadership skills and experience interacting with senior clinicians and KOLs 
-Strong analytical skills and ability to oversee junior data science staff 
-Ability to think strategically about clinical development requirements but also execute day-to-day activities 
-Ability to work in startup environment, initially being an individual contributor and helping to grow team

How to Apply

Send your resume and salary expectations to careers@dotlab.com, and please name your resume file as: [Last Name] [First Name] [Resume], [Role of Interest]. We'll get back to you if there is a potential fit!

About Our Organization

DotLab is a personalized medicine company for women's health that has developed the first-ever non-invasive test for endometriosis, a chronic disease that affects 1 in 10 women worldwide and is a top cause of unexplained infertility. We have been recognized by Goldman Sachs for entrepreneurship, the World Technology Network for health and medicine, Forbes as a top 10 female-founded tech startup, a technology to watch by the MIT Technology Review, and by the American Society of Reproductive Medicine for our scientific research.

 

DotLab is an Equal Employment Opportunity (EEO) employer and does not discriminate on the basis of race, color, national origin, religion, gender, age, veteran status, political affiliation, sexual orientation, marital status or disability (in compliance with the Americans with Disabilities Act) with respect to employment opportunities.