Executive Director, Clinical Development (MD)

Overview

As a member of the Clinical Leadership Team, the Executive Director, Clinical Development will serve as a subject matter expert and team leader for programs/indications in allergy, dermatology, and other therapeutic areas within immunology. The Executive Director is expected to function at the highest level with multiple responsibilities: shaping clinical development strategy with a focus on development and execution of clinical trials, including Phase 1 through Phase 4 studies, overseeing study patient safety, playing key roles in data collection and analysis, creation of critical scientific content, attendance at advisory boards and various scientific congresses, and KOL engagement efforts.

Responsibilities

• Oversee the clinical development of clinical programs, including planning, execution, and monitoring of Phase 1-4 clinical trials
• Collaborate with other members of the clinical trial team and colleagues in clinical pharmacology, translational medicine, and pharmacovigilance, to develop clinical trial protocols, briefing documents, and other regulatory and regulatory documents (IND, BLA, NDA, annual reports, etc.)
• Ensure all clinical development activities are performed on time and to the highest standards of quality
• Provide medical support to clinical operations, regulatory and preclinical programs
• Medical monitoring with oversight of patient safety
• Training and collaboration with staff within the areas of responsibility
• Assess external clinical research proposals involving company products and manuscripts that are being prepared for publication
• Work with external partners, including CROs, academic institutions, and key opinion leaders (KOLs), to enhance the development programs and ensure successful execution of clinical trials.
• Lead the interpretation of clinical trial data and collaborate on the preparation of clinical study reports, presentations, and publications for scientific conferences and peer-reviewed journals
• Develop a strategically and commercially aligned scientific engagement and communication strategy for key immunology assets

Qualifications

• MD, with specialization in one or more of the following preferred: allergy/dermatology/immunology/pulmonary/GI
• Minimum of 8 years of experience in clinical development at a biotechnology or pharmaceutical company
• Demonstrated experience in clinical research, including creating clinical development plans, and designing, planning and monitoring clinical trials, particularly Phases 2-3
• Clinical development experience with biologics or small molecule agents addressing immunologic and allergic diseases preferred, such as chronic urticaria, allergic asthma, and additional mast cell-driven diseases
• Experience with preparing clinical sections of regulatory submissions (e.g., NDAs and INDs) preferred
• Strong experience reviewing and interpreting study data/reports
• The ability to interact effectively with investigators and scientific experts
• Demonstrated ability to work effectively in cross-functional teams
• Excellent oral and written communication skills
• Excellent interpersonal and organizational skills and attention to details
• Experience with FDA/EMA processes (IND filing, NDA filings) desirable
• Strong knowledge of MS Word, Excel, and PowerPoint
• Strong written and interpersonal skills