Executive Director, Clinical Development

Overview

The Executive Director leads late-stage clinical development activities for one or more compounds in development.  This position requires a strategic mindset and flexible thinking to enable design and execution of the clinical development strategy while providing medical and scientific leadership for Celldex sponsored protocols. The Executive Director is expected to function at the highest level with multiple responsibilities: overseeing study patient safety, playing key roles in data collection, data cleaning and data analysis; training internal and study site staffs on study procedures, addressing study related medical and protocol issues; providing medical expertise and medical support including feasibility assessments, medical training, and medical/clinical input for the design of study protocols and clinical development programs; ensuring the medical and scientific quality of clinical trial protocols, case report forms, and clinical trial reports; providing medical and strategic input into the design of clinical development programs and study protocols.

Responsibilities

• Oversee the clinical development of multiple programs, including planning, execution, and monitoring of phase 1/2/3 clinical trials
• Collaborate with the regulatory team 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, within budget, and to the highest standards of quality
• Provides 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
• Assesses 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

Qualifications

• MD, with specialization in one or more of the following preferred: allergy/dermatology/immunology/pulmonary
• Minimum of 8 years of experience in a 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, mast cell 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 function on an even scientific and clinical level with investigators and 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
• Strong written and interpersonal skills