This position is no longer open for applications

Kelly Scientific is looking for an Senior Clinical Scientist for its pharmaceutical partner based in the Neuchatel canton.
(long term temporary position)

Missions:

• You will provide scientific expertise necessary to design and deliver clinical studies and programs.
• You will be responsible for implementation, planning, and execution of assigned clinical trial activities.
• You will successfully lead, plan, and execute trial level activities for multiple trials with minimal to moderate level of supervision.
• You will provide scientific and clinical leadership to clinical scientists on study team (matrix leadership).
• You may support clinical development planning in collaboration with Early Clinical Development physician(s).

Responsibilities:

• Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members.
• Plan and lead the implementation of clinical study startup/conduct/close-out activities as applicable.
• Evaluate innovative trial designs in collaboration with the study physician.
• Manage protocol and ICF development process (e.g., documents and amendments) with minimal guidance; includes writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to governance committee and early clinical development team meetings as required.
• Serve as primary contact for site-facing activities such as training and support for clinical questions.
• Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review.
• Identify clinical data trends; provide trends and escalate questions to study physician.
• Develop clinical narrative plan and review clinical narratives.
• Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
• Review/develop site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., safety review) activities.
• Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).
• Collaborate and serve as primary liaison between external partners for scientific advice.
• Author/review abstracts, presentations, and manuscripts for external publications

Profile:

• Degree in Life Sciences (MD, PhD, Pharm D, Master or similar scientific field preferred).
• Min of 5 years of experience in clinical science, clinical research, or equivalent.
• Good knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
• Must be able to effectively communicate and collaborate across functions and job levels.
• Ability to assimilate technical information quickly.
• Routinely takes initiative.
• Proficient in Medical Terminology and medical writing skills.
• Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).
• Proficient critical thinking, problem solving, decision making skills.
• Willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
• Proficient planning/project management skills
• Travel Required Domestic and international travel may be required (approximately 10-25%)

Your contact at Kelly:
Mrs Karine Legerot
Consultant Professional Staffing Life Science
Kelly Scientific Geneva