Director/Sr. Director, Clinical Development

We are seeking a clinical development professional to design, execute, and interpret clinical trials/research and data collection activities in support of the overall Product Development Plan and the corporate strategy and goals of the company. The successful candidate will effectively collaborate with cross-functional teams to generate, deliver, report, and interpret high-quality clinical data supporting the scientific, product and business strategy, including monitoring adherence to protocols and ensuring correct endpoint data collection. Please note this is an onsite opportunity.

Responsibilities: 

• Serves as clinical lead designing Clinical Development Plans.
• Designs, conducts, and reports clinical trials in line with the development, regulatory and commercial strategy. 
• Serves as the primary medical contact for assigned clinical trials, ensuring protocol adherence and safety oversight.
• Addresses medical inquiries from investigators, regulatory agencies, and internal teams, ensuring consistent application of protocol guidelines.
• Monitors clinical trial conduct, assessing safety data, adverse events (AEs), serious adverse events (SAEs), and emerging safety signals.
• Provides medical expertise in study design, protocol development, and execution, collaborating with cross-functional teams to advance clinical programs.
• Supports site selection, patient recruitment, and investigator engagement through regular interactions and guidance. In partnership with Clinical Operations, responsible for oversight of study enrollment and overall timelines for key deliverables.
• In collaboration with other functions, responsible for opinion leader development and investigator recruitment within the therapeutic area. 
• Leads in scientific education of investigators, clinical monitors, and Global Project Team members related to therapeutic area.  
• Keeps abreast of professional information and technology through conferences or medical literature and acts as a therapeutic area resource.
• Responsible for understanding the regulatory requirements related to clinical studies and accountable for complying with those requirements. 
• Coordinates and develops information for reports submitted to the FDA and Global Regulatory Authorities.
• Leads cross functional sub-teams responsible for defined sub-projects within the therapeutic area.

Qualifications:

• Medical Degree (MD or equivalent; MD/PhD) with a minimum 5+ years’ drug development experience.
• Knowledge of regulatory requirements governing clinical trials and experience in the design and successful execution of clinical trials are required.  Experience in both first in human and registration-track trials leading to regulatory submission is strongly preferred. May have performed protocol design in the academic environment and/or acted as an assistant Principal Investigator or Principal Investigator.
• Direct experience with regulatory bodies (FDA and Global regulatory agencies) is highly advantageous.
• Demonstrated ability to influence, cross functionally collaborate and gain cooperation from others, conduct presentations of technical information concerning specific projects/schedules, etc.
• Excellent oral and written communication skills and demonstrable evidence of being a motivated and successful self-starter.
• Willingness to travel as needed.

City Therapeutics is accepting resumes/CVs from direct applicants only.  Recruitment Agency submissions will not be accepted at this time.

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.