I'm partnered with an industry leading Biopharmaceutical company in the New Jersey area. This company is special and one of the best you can join in the NJ area for a couple reasons. First off, they have a well-balanced pipeline across various therapeutic areas giving the company significant stability compared to its competitors. In addition, they have one of the most robust Immunology pipelines of any top 20 biopharma globally!
The Clinical Development Director- Immunology/Rheumatology will be involved in multiple product development projects. With a focus on rheumatology, the Clinical Development Director will directly report to the Head of Clinical Development 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 5+ years of experience in clinical development in the pharmaceutical industry, preferably with neurology compounds or relevant academic research experience
- Possesses strong clinical development Immunology/Rheumatology 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!