About DermBiont:
Organization:
DermBiont’s mission is to become the world’s leading precision dermatology company developing targeted topical therapeutics that treat, cure, and prevent diseases. The company aims to impact the root cause of skin diseases with biotherapeutics that repair an imbalance of the microbiome as well as through the development of targeted small molecule therapeutics with well-defined mechanisms of action.
We are led by a highly experienced team of entrepreneurs with deep industry history and a long track record of achievement and success.
DermBiont is a fast-paced organization with a start-up mentality and multiple ongoing active trials. Our team moves fast, works efficiently, and has a willingness to pitch-in and multi-task. This role will allow you to make a meaningful impact in our organization and allow you to collaborate on a team to change the dermatology industry with our transformational approach to skin disease.
If you have managed clinical trial successes, are a hardworking hands-on team player, would like to have an impact on the company and the industry, want to join a great team of industry veterans, and do not mind stepping in where you are needed to get the job done, we are excited to meet you.
Summary and Scope of Position:
Lead initiation, conduct, and steer completion of clinical trials. This is a hands-on and in-person position.
Primary Responsibilities:
- Assist with the development of protocols as they relate to the operational aspects of the trial.
- Lead the creation of consent forms, monitoring plans, case report forms, source documents, and other clinical documents related to clinical trials.
- Review medical monitoring plans.
- Lead the selection and management of CROs, vendors, and other consultants to ensure adherence to domestic and international regulations and standards (GCP, MDD, ICH).
- Assist with the negotiation of contracts and budgets with clinical investigators and other vendors.
- Participate in the development and maintenance of clinical project timelines.
- Work closely with CMC and Research departments to ensure adequate clinical and non-clinical supplies.
- Ensure investigative site compliance with protocols and overall clinical objectives; including traveling to sites to conduct pre-study, initiation, interim and closeout visits, site and study management, trial management file maintenance, and/or co-monitor with CRO or contract associates.
- Organize and manage SIV’s.
- Supervise clinical site monitors (internal and/or contract).
- Assist the Medical Monitor in safety review and reporting.
Additional Essential Functions:
- Lead internal study team meetings.
- Work with project management to keep the project plan current and managed to critical path.
- Work closely with the Chief Medical Officer and Director of Clinical Operations to lead the planning and execution of successful Investigator meetings.
- Participate in preparation of IRB or International Ethics Committee submissions as required.
- Perform other related duties as required to support the Clinical Operations Team and company goals.
Qualifications/Requirements/Skills:
- BS or equivalent experience in a scientific or medical discipline with 5 years clinical trials management experience.
- Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors).
- Previous clinical trial management or project management experience with demonstrated leadership ability.
- Previous direct (no CRO or SMO involvement) clinical trial management experience highly desired.
- Experience with Electronic Data Capture (EDC) systems; UAT experience desirable.
- Excellent communication; interpersonal skills and influencing skills
- Ability to determine the resources and support to meet project goals and timelines.
- Previous budget and contract negotiation experience.
- Knowledge of good clinical practices (GCP) with current GCP certification.
- Ability to leverage own expertise and input from others to identify issues and make recommendations that address overall corporate and program needs.
- Able to work in a fast-paced environment and effectively multi-task.
- Able to work independently.
- Excellent time management skills (timelines, schedules, task prioritization).
- Willing and able to travel, including within the U.S. and internationally, including Central America.
- Proficiency using Microsoft Outlook, Word, PowerPoint, and Excel.
- Willing and able to be located or relocated to Emeryville, CA
- This is an in-person position
