Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Celgene R&D is at a critical and exciting phase of development. As it expands and integrates its portfolio, there is an opportunity for a dynamic and resourceful individual to lead regulatory precision medicine and companion diagnostic programs at our site in Summit, NJ.
Translational Development at Celgene
Translational Development is part of the Global Research and Early Development organization in Celgene and leads early stage clinical, pharmacological and translational research and development activities for the pipeline and supports late stage portfolio for regulatory, translational development and life cycle management. The Translational Development team is in the process of establishing a precision medicine and companion diagnostics group to support multiple disease areas of interest including Myeloma, Lymphoma, MDS/AML and other hematological malignancies. In addition, this group will be responsible for supporting our inflammatory disease programs as well.
This group will integrate scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients and physicians we serve. This position will be responsible for leading the regulatory aspects of precision medicine and companion diagnostics programs across the Celgene organization.
The incumbent will be based in Summit NJ and will be the regulatory lead for precision medicine and companion diagnostics organization.
Responsibilities will include, but are not limited to, the following:
- Provide Regulatory Leadership on the development of biomarkers, companion diagnostics and associated devices. Its purpose is to help guide early development decisions by providing cutting edge regulatory strategy, and laying out the pathway to facilitate research and development of personalized therapies.
- To provide expert know-how on regulatory requirements for the validation of biomarkers, development of companion diagnostics, and devices, globally, especially in the US and Europe.
- To partner with global regulatory project leads and senior regulatory colleagues, to provide advice and guidance on drug/biologic development programs, especially to work alongside the Regional VPs (Americas, Europe), three Global TA Heads (US).
- Lead regulatory strategy for biomarker to Companion Diagnostic transition
- To extend Celgene’s reach into key FDA capabilities (such as CDER, CBER and CDRH) to enable effective communications, dialogue and facilitated submissions that provide for efficient development of biomarkers, companion diagnostics and devices.
- To work alongside the discovery, development and Translational Medicines functions to provide seamless regulatory input that adds value to, and supports effective development decisions.
- To work alongside Drug Safety function to evaluate safety parameters and develop risk management & risk mitigation strategies.
- To work alongside the VP Regulatory Intelligence & Policy to ensure cutting edge know-how is available to Celgene and that the ability to influence events in a rapidly evolving regulatory environment, is facilitated.
- To ensure and assure compliance of Celgene programs with regulatory requirements for diagnostics and devices.