Rejuvenate Bio is creating a revolutionary approach to full age reversal.
Approach: Aging is caused by the dysregulation of multiple systems in the body that manifest itself in age related disease. Current solutions focus on each problem individually, ignoring the interconnectedness of the challenge. Rejuvenate Bio utilizes gene therapy, proprietary targets, and the animal health market to bring anti-aging therapies to market in an incredibly capital-efficient manner. With drastically lower regulatory requirements and ever-increasing demand for treatments in animal health, Rejuvenate Bio can drive early revenue and enhance the value of its human programs, both through strong pre-clinical data and long-term validation of its overall approach. Rejuvenate Bio’s lead therapy has demonstrated the ability to treat heart failure, kidney failure, diabetes, and obesity in mice and has also shown to be safe and efficacious in dogs. In 2022, Rejuvenate Bio will complete its final clinical trial in animal health before bringing its first product to market. This trial will also act as the final pre-clinical study needed for its first human therapy.
Duties & Responsibilities
Rejuvenate Bio is looking for a highly motivated individual to join our energetic team and lead our clinical activities. The Chief Medical Officer is responsible for clinical study strategy, planning and execution and includes, but is not limited to, participation in the preparation of study related materials, management of CROs and other study vendors, identification of project risks and contingency planning, as well as management of the project budget, study timelines, and study deliverables.
Responsibilities will include:
• Manage clinical study activities from study start-up through database lock and clinical study report, ensuring adherence to protocol, ICH/GCP, and relevant SOPs
• Actively participate in the selection of vendors, including CROs
• Prepare and review documents related to the clinical study, including Informed Consent Form(s), study plans, and site budget templates; participate in Case Report Form design and user acceptance testing
• Manage studies within agreed timelines and budget, and coordinates cross functional efforts to achieve study objectives and goals
• Establish and maintain effective relationships with investigator sites and study vendors
• Provide operational oversight of the CRO and study vendors as the primary point of contact; monitor progress and quality metrics, identify risks and issues, and implement appropriate mitigation activities and/or contingency plans
• Review monitoring reports, protocol deviations, and data listings to ensure reliable quality data are delivered; performs oversight monitoring visits as needed
• Provide oversight of the clinical trial master file to ensure compliance with quality standards and maintain inspection readiness
• Effectively communicate with the study sites
• M.D. or Ph.D. Degree is required
• 10+ years of clinical research experience with 5+ years as a clinical project manager; experience in rare diseases and/or difficult to recruit patient populations is preferred If interested email email@example.com with a resume and cover letter. We are located in San Diego California.
• Demonstrated success working with and influencing key external stakeholders (KOLs, investigators, researchers) including presenting/responding to the FDA and other regulatory authorities
• Strong project management and risk management skills, including management of study vendors
• Excellent listening and communication skills, as well as organizational skills
• Strong knowledge of ICH Good Clinical Practice principles
• Experience in Gene Therapy highly preferred
• Site monitoring experience is preferred
• Ability to travel both domestically and internationally, if required
• Role requires semi-regular in-person presence in San Diego CA and team operates during west coast time zone "working hours.”
If interested, email firstname.lastname@example.org with a resume and cover letter. We are located in San Diego California.