Description
Overview
The Senior Director leads clinical development activities for one or more compounds in development - The position generates clinical development strategy & plans and provides medical & scientific leadership for Celldex sponsored protocols. The Senior Director oversees study patient safety, plays key roles in data collection, data cleaning and data analysis. Trains internal and study site staffs on study procedures, and addresses study related medical and protocol issues. Provides medical expertise and medical support including feasibility assessments, medical training, and medical/clinical input for the design of study protocols and/or clinical development programs. Ensures the medical and scientific quality of clinical trial protocols, case report forms, and clinical trial reports. Provides medical and strategic input into the design of clinical development programs, and study protocols.
Responsibilities
- Creates clinical development strategy for one or more Celldex compounds.
- Responsible for medical content for clinical development plans, clinical protocols, and regulatory documents (IND, NDA, annual reports, etc)
- 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.
- Acts as a liaison between the company and clinical investigators.
Qualifications
- MD, with specialization in allergy/dermatology/immunology/pulmonary related field preferred.
- Experience in Biotech and or Pharma (5 years minimum)
- Demonstrated experience in clinical research, including creating clinical development plans, and designing, planning and monitoring clinical trials, Phases I-III
- Strong experience reviewing & interpreting study data/reports.
- Experience with preparing clinical sections of regulatory submissions, including INDs and NDAs
- Clinical development experience with biologics or small molecule agents addressing immunologic and allergic diseases preferred, such as chronic urticaria, allergic asthma, graft vs host disease, mast cell diseases.
- 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 processes (IND filing, NDA filings) desirable
- Strong knowledge of MS Word, and Excel
- Strong written and interpersonal skills
- The ability to work independently and as part of a team
