Clinovo · 3 hours ago
Senior Director, Clinical Development
United States
Full-time
Remote
Lead/Staff, Director/Executive
$250K/yr - $275K/yr
5+ years expClinovo is a company focused on clinical development, and they are seeking a Senior Director of Clinical Development. This role will oversee the design, development, analysis, and reporting of clinical studies, ensuring compliance with clinical development plans and regulatory standards.
BiotechnologyHealth CareHospitalPersonal Health
Responsibilities
Provide hands-on guidance for all clinical research activities per the GCP guidelines leading to NDA and post-approval
Responsible for creation of all clinical documents or clinical parts of all regulatory documents including, but not limited to protocols, IBs, clinical data reviews, CSRs, regulatory submissions and publications or presentations associated with the clinical trials
As senior member, represent Clinical Development in early and late phase clinical development cross-functional teams/meetings
Responsible for leading the review of accumulating clinical safety data, including protocol deviations and serve as Medical Monitor for assigned studies
As a subject matter expert represents Clinical Development for regulatory interactions, investigators and expert advisory board meetings, external professional societies, and meetings
Collaborate with a cross-functional study team including clinical operations, data management and other experts in the review, querying, and reconciliation of clinical study data
Ensure resolution of identified issues during clinical study data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Operations team Support creation of clinical development plan/s
Support Clinical Operation Leads and Clinical Project Managers for successful launch and execution of clinical programs. who is acting as a contact for the program team and the clinical sub-team
Serve as the primary contact person independently responding to all the study related inquiries from clinical trial sites and study teams
Perform other clinical duties when requested
Qualification
Required
MD, PhD, D.O., Pharm D., RN degree
A minimum of 5 years of clinical development industry experience in the biotechnology/biopharmaceutical industry
Strong analytical skills, especially with regard to understanding and interpreting scientific and clinical research and literature are essential
Demonstrated team member who shows model collaborative behavior, ability to interact and communicate openly and effectively with the internal team, external partners, and external key opinion leaders as well as work independently
Exceptional attention to detail and excellent organizational skills
Demonstrated ability to comply with project plans and timelines, oversight collaborate with Clinical Research organization in project and program teams
Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures
Experience in development of protocols, study reports, IBs, and other key clinical documents
Ability to thrive in a dynamic and fast-paced environment
A dynamic self-starter with a positive attitude
Ability to prioritize duties and manage multiple matters from start to finish with a demonstrated ability to lead change
Excellent written and verbal communication and high-level negotiation skills; strong presentation skills are important
Adept, nimble, energetic, and comfortable in a fast-paced, dynamic, and collaborative environment
Demonstrated ability to effectively lead multi-disciplinary teams
Ability to assimilate new information rapidly, multi-task, and work across multiple projects
Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc
Some travel would be required for site selection and training, monitoring responsibilities and educational seminars. Ability to travel approximately 25%
Preferred
Experience in ophthalmology clinical trials is strongly preferred
Company
Clinovo
Clinovo provides drug development and solutions.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2015-12-28Angel
2014-01-01Series Unknown
Recent News
Keiretsu
2024-11-04
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