Clinical Research Director, I&I
Apply NowCompany: IMS Group
Location: Cambridge, MA 02139
Description:
Job Descriptions:
Job Requirements:
- Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
- Advance the CDP through internal management review
- Leads a clinical sub team to design clinical studies and to create an abbreviated and full clinical study protocol
- Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
- Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
- Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation)
- Contribute to data review, interpretation and publication of clinical study results
- Represent Clinical Development at Health Authorities and incorporating advise into development strategy
- Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program
Job Requirements:
- Medical Doctor. Should be board certified or equivalent in internal medicine / clinical immunology. Gastroenterology is a plus
- Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent
- More than 5 years of relevant clinical, scientific and/or industry experience within the field of immune driven diseases. Gastroenterology is a plus.
- Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience internal medicine, clinical immunology. Gastroenterology is a plus
- Knowledge of drug development preferred
- Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment
- Performance oriented with ability to work along agreed timelines
- Be experienced in advancing assets from discovery into clinical development
- Have experience in novel approaches in translational medicine
- Have and maintain deep scientific, technical and clinical knowledge in immune driven disease and clinical immunology. Gastroenterology is a plus.
- Demonstrated problem solving skills
- Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
- Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome
- Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods