Medical Director

The individual will provide clinical leadership to business development, regulatory strategy and interactions to ensure cross regional consistency. The medical director will develop a clinical strategy for disease programs to meet corporate goals and objectives, applicable regulatory requirements, Good Clinical Practices (GCPs) and Standard Operating Procedures (SOPs).

Responsibilities

The Medical Director will take a leadership role in planning the overall strategy for clinical drug product development, participate in determining the course of action necessary to meet the goals and objectives of specific projects and represent CSC research and development in outside discussions and medical scientific forums. The Medical Director will also:

• Participate in the planning, writing and review of clinical study reports, regulatory updates and submissions and assure their timely completion. Support regulatory fillings including INDs and NDA fillings.
• Design, prepare and initiate clinical study protocol and select vendors for clinical trials (CROs, central labs etc). Work on regulatory issues around approval from clinic
• Finalize protocols, and assure timely completion and quality and accuracy of study reports
• Develop and execute a plan for launching the study and ensure effective study design preparation, initiation and safe conduct of trials and conduct and quality interpretation of study results.
• Participate in the selection of clinical investigators, provide proper investigator profile for study, and assist in conducting investigator meetings.
• Complete clinical trials application, and organize, manage and direct the activities of the clinical team established to take primary responsibility for completing the clinical development project
• Work actively engaging with clients, direct and assist internal staff, CROs, and consultants as required
• Monitor progress against expectations on timeline
• Manage relationships with all the investigators and clinical sites
• In conjunction with clinical operations, oversee day to day operation of ongoing clinical studies, if necessary, visit selected sites to trouble shoot, train/retain staff.
• Accurately interpret and communicate clinical trials results orally or via written documents

Requirements

• M.D. degree and 3-5 years of hands-on experience in Phase I-III drug development in the Biotech and/or Pharmaceutical industry.
• Cell-based therapeutic development experience preferred.
• Experience monitoring clinical trials with appropriate knowledge of GCPs regulations.
• Excellent partnering skills; strong interpersonal skills and leadership abilities