The Clinical Development Director- CNS will be involved in multiple product development projects. With a focus on epilepsy, the Clinical Development Director will directly report to the CMO and offer therapeutic and pharmacovigilance experience to the clinical development of the therapeutic medications. Each product development project will receive clinical operational support from the director of clinical development. To enable the development of overall goods, the Director will collaborate with regulatory, discovery, business development, legal, quality, and CMC.
Essential Duties & Responsibilities
- Participate in the design and conduct of clinical trials and, as a member of the Clinical Development/Medical Affairs team, provide operational oversight by working with internal and external operations personnel.
- Participate in the development of product development plans and clinical trial strategy.
- Offer medical advice on product development or other scientific matters for medication development and senior management.
- Participate in pharmacovigilance activities such as SAE evaluation and reporting and analysis of safety data.
- Participate in the preparation of protocols, Investigator Brochures, clinical study reports, safety reports, the clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and posters.
- M.D. degree mandatory
- Practice experience preferable but not required
- Minimum of 3 years of experience in clinical development in the pharmaceutical industry, preferably with neurology compounds or relevant academic research experience
- Possesses early phase clinical development Neurology/CNS/Epilepsy experience
- Clinical development experience in the pharmaceutical/biotechnology industry or academic medical setting
- This organization offers a competitive salary, bonus structure and stock options
- Full coverage of Medical Dental and Vision
If you are interested in the Director of Clinical Development role please don't wait to apply!