Medical Director/Senior Medical Director
The Medical Director/Senior Medical Director will be responsible for protocol design, safety monitoring, study conduct, data review and medical writing activities associated with Cidara’s clinical studies. In addition, this position will include heavy participation in regulatory submission and business development initiatives. This position will report to the Chief Medical Officer
- Provide hands-on leadership and support to the creation of Phase 1, 2 and 3 clinical study designs for multiple products in various indications.
- Provide clinical expertise and protocol training for various infectious diseases.
- Participate as a key contributor to FDA regulatory submissions throughout the development program.
- Ongoing review of safety data emanating from clinical studies and work closely with Pharmacovigilance on the submission of safety data to the FDA and other regulatory bodies.
- Work closely with Clinical Operations personnel on the planning and execution of clinical trials.
- Responsibility for the medical content of clinical research protocols, investigator brochures, consent forms, protocol amendments, and CRFs.
- Consult with Investigators on eligibility and treatment related issues during clinical trials.
- Responsible for successful and timely recruitment of appropriate clinical research study participants in line with corporate goals.
- Establish and maintain excellent relationships with FDA medical staff.
- Key participant for drug supply forecasts and study drug distribution plans.
- Ensure completion of contracts with Investigators and study sites.
- Adhere to aggressive IND and NDA timelines, implementing product development accordingly.
- Key contributor to publication planning efforts.
- Develop and supervise budgets associate with clinical trials.
- Ensure excellent personal relationships with clinical investigators and opinion leaders, with episodic heavy travel requirements.
- M.D. with specialization in infectious diseases, internal medicine, or hematology/oncology.
- Active US board certification preferred.
- Some experience in immunology preferred
- Excellent working knowledge of GCP/ICH and FDA regulations/practices, and experience with registration submissions.
- Excellent data analysis and regulatory writing skills.
- Ability to excel in smaller entrepreneurial organizations.
- Track record of establishing excellent working relationships with opinion leaders and clinical investigators.
- Superior team leadership skills.
- Minimum 5-7 years clinical research experience including industry experience with operational and medical responsibility for Phase 2 and Phase 3 clinical trials.
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.
Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company