My client is a Pharmaceutical company and specializes in GI diseases.
 
Purpose of this role:
Working with the Global Clinical Development Lead, the Clinical Scientist will lead clinical development activities relating to the design, execution, and interpretation of clinical trials and the clinical development plan. You will represent clinical science on study management teams, training internal and external staff, monitoring clinical data, and responding to health authority requests related to the assigned clinical development activities. You will be the expert on assigned protocols and address issues along with clinical operations or the medical team as they arise. You may lead clinical science activities in other programs depending on business need. 
 Major Responsibilities:
The Clinical Scientist will be responsible for supporting the overall clinical and scientific activities regarding study planning, preparation, management, evaluation, monitoring and documentation. In conjunction with the Global Clinical Development Lead, will:

• Lead development of the clinical development plan of assigned compounds, and lead development of related study synopses and protocols, and protocol-related documents.

• Provide clinical science input to and be primary clinical science contact for protocol-related documents and processes. May lead cross-functional subteam for defined projects.

• Ongoing review of data during trial conduct and addressing any quality issues identified

• Provide oversight for clinical science activities performed by external vendors (e.g. medical review of data, protocol deviation reporting, site questions etc.), in collaboration with clinical operations.

• Maintains thorough and up-to-date knowledge for regulatory requirements related to clinical studies and ensures GCP compliance in assigned tasks.

• Contributes to briefing packages and provides responses to relevant questions from health authorities and institutional review boards (IRB)

• Gives clinical and scientific input to and reviews clinical regulatory documents (clinical study reports, investigator’s brochure, safety reports, submission to health authorities)

• Be a major contributor to EMA PIP and FDA PSP development and associated regulatory interactions.

• Provide clinical scientific input for final study reports and annual report documentation

• Serve as trouble-shooter and internal key contact on clinical and medical issues and aspects of assigned studies

• Responsible for training and science support to operation colleagues and study site staff

• Speak with clinical site staff to address questions and provide updates

• Represents clinical science in study management teams

• Assist in preparing materials for use in internal and external presentations (e.g. advisory board meetings, steering committee meetings, etc.).

• May assist or lead development of advisory boards

Profile (Skills, experiences and qualifications required for the job)

• The successful candidate will be a highly motivated self-starter with strong leadership skills who thrives on working in a team environment, applies independent thought and creativity in programs or projects, and skillfully influences and holds others accountable in achieving team goals.

• PhD-/MD-/PharmD-level (or equivalent relevant experience) and five or more years of experience in clinical drug development.

• Proven experience in design, conduct and data analysis of registration-track global clinical trials. Experience designing and conducting rare disease clinical trials is strongly preferred. Substantial experience as an academic principal investigator for industry-sponsored trials can be considered.

• Has and maintains thorough knowledge of own therapeutic area or disease specific information, keeps abreast of relevant scientific literature and competitor development programs, and applies this knowledge to advance projects or programs.

• Acts as a therapeutic area resource and leads or assists in scientific education of investigators, study execution team and cross-functional team members.

• Knowledge of regulatory requirements governing clinical trials and extensive experience in development of and writing of registration-track clinical trial protocols plus other trial related documents.

• Experience in interactions with ethics committee, regulatory authorities and other external agencies

• Previous experience in providing oversight to vendor activities including CRO

• Demonstrated experience managing complex projects, and polished skills in influencing, communicating, and working collaboratively with diverse stakeholders.

• Adaptable team player able to work independently, exhibit sound judgement, and hold self and team members accountable in meeting timelines.

• Effective and engaging scientific communicator, with excellent oral and written presentation skills.