Job Description

Job Description

The Principal Clinical Scientist (PCS) supports the translational activities between the MS/Immunology Development and Research Units (DU, RU) and will serve as the first line scientist expert for the late stage clinical assets in MS and in lupus. In this capacity, the PCS will work in close collaboration with the clinical, research, medical and regulatory teams to support regulatory activities, in particular filing activities, post marketing commitments and scientific MOA questions for the assets. The PCS will help coordinate a close collaboration between the RU and DU together with the portfolio director. In addition, the PCS will partner with external innovation for the conduct of potential business development activities and with clinical development for biomarker studies.

Job Responsibilities:

* Will report to a more senior member of the MS/Immunology clinical team who has direct responsibility for the overall research strategy and clinical and scientific development activities
* Represent clinical RU & DU interface in cross-functional project core teams
* Serve as research expert in communications with Regulatory Authorities worldwide and collaborate with clinical and regulatory teams
* Serves as a primary point of contact for emerging scientific questions for the late stage clinical assets in MS and lupus
* Drive development of clinical development plans and protocols for biomarker clinical studies (SRC, POB/early POC studies)
* Monitor, review and interpret safety and efficacy data of ongoing studies.
* Assist in clinical study data analysis
* Provide clinical and research scientific input to business development (e.g. due diligence)
* Perform literature research as needed
* Develop and deliver presentations to internal and external stakeholders
* Must ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice
* May interface with key medical experts and represent the team at medical congresses and conferences

Provide medical scientific content expertise to internal and external stakeholders
Qualifications

* PhD degree preferred, would also consider other higher education degrees (MD, PharmD).
* At least 3-5 years experience including clinical research or basic research in academia and/or of progressive responsibilities in drug development in industry (preference is to have industry exp). Proven track record in supporting regulatory engagements with a preference for late stage study experience. Experience in lupus or MS is also desirable.
* Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.
* Demonstrated strategic and critical thinking.
* Excellent communication skills (oral and written) and excellent organizational skills.
* The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.

Additional Information

The Principal Clinical Scientist (PCS) supports the translational activities between the MS/Immunology Development and Research Units (DU, RU) and will serve as the first line scientist expert for the late stage clinical assets in MS and in lupus. In this capacity, the PCS will work in close collaboration with the clinical, research, medical and regulatory teams to support regulatory activities, in particular filing activities, post marketing commitments and scientific MOA questions for the assets. The PCS will help coordinate a close collaboration between the RU and DU together with the portfolio director. In addition, the PCS will partner with external innovation for the conduct of potential business development activities and with clinical development for biomarker studies.

Successful candidate will:

* Lead and/or support the preclinical regulatory activities for multiple assets in immunology and MS
* Serve as the primary point of contact for emerging scientific questions on MOA for late stage assets in MS and immunology
* Assist in the development and implementation of the RU/DU collaboration and strategy
* May support a clinical program team in context of a biomarker study or collaboration