The VP, Clinical Development will be responsible for the development of the clinical strategy for all development programs in coordination with the CMO/ Chief Medical Officer; design the respective clinical studies;  and work with the Head of Clinical Operations on the clinical studies.

The VP Clinical Development is expected to build the Clinical Development team for EG 427. The candidate is expected to work with the Regulatory consultants on the clinical aspects of Regulatory agency packages and meetings. The VP of Clinical Development is expected to seek external expert input into the clinical study designs and work with the consultant statistician on the statistical aspects of the clinical studies. Expertise in Clinical Development on a global level for phases 1b-3 in several indications is required as well as experience in representing Clinical devekopment at expert advisory board meetings and Reguatory agency meetings. Profound knowledge of ICH GCP is essential.

The VP Clinical Development will have two direct reports in the initial phase: the Head of Clinical Operations and the Clinical Scientist (new position – to he hired).

The VP, Clinical development:

• Will be part of the senior leadership team

• Develop the Clinical strategy in coordination with the CMO

• Be  the author of the  Clinical Development plan (CDP) for all compounds in coordination with the CMO and in collaboration with all functions involved

• Develop the timelines and budget estimates for the CDP in collaboration with the Head of Clinical Operations, Finance, CMC and all departments

• Be responsible to develop the respective clinical study protocols in collaboration with the consultant biostatistician, assigned Medical Writer, and all functions involved

• Will seek external medical expert input into the study protocols, including organization of Clinical Advisory Board meetings with all functions involved

• Work collaboratively with the Head of Clinical Operations on the selection of the clinical CROs (contract research organizations) and study sites

• Work with the Head of Clinical Operations on medical aspects for the ongoing clinical studies

• Build up the Clinical Development team across all indications

• Will be the primary contact for all Medical Monitors at the respective CROs and work on specific safety aspects with the Medical Monitors and other functions as required

• Provide Clinical Development input into Regulatory Agency packages and represent Clinical Development at Regulatory Agency meetings

• Be able to present clinical study results internally and externally

• Be the manager for the Head of Clinical Operations and the Clinical Scientist (new position, to be hired) initially

The job is a full time position and is based in the US East coast.

• MD degree is essential

• Board certification in Neurology

• Clinical development experience on a global level of at least 6 years in neurological indications

• Experience in developing the Clinical strategy for compounds in development and clinical study protocols

• Experience in representing Clinical development at Regulatory agency meetings

• Experience is presenting scientific-medical data to internal and external audiences

• Strong organizational skills and attention to detail

• Collaborative approach to overcoming challenges

• Experience in managing direct reports

• Self-motivated, self-disciplined and able to function collaboratively as part of a team

• Strategic agility, strong critical and logical thinking with ability to analyze problems

• Strong ability to prioritize in a fast moving environment

• Must be fluent in English (both spoken and written)

• Extensive knowledge of ICH GCP

• Interview with the CMO

• Interview with the CEO

• Meeting with members of the team

• Professional references