Clinical Scientist

Description

We are seeking a dynamic and highly motivated scientist to play a central role in our team. Attention to detail, a robust scientific background, and the ability to contribute to our collaborative and entrepreneurial culture are essential. The Clinical Scientist is responsible for providing scientific input during protocol development, study design, oversight of clinical aspects of study conduct, and interpretation of study results through the final study report. The Clinical Scientist will work closely with other members of the clinical development and operations teams to execute and deliver milestones. The successful candidate will be highly collaborative and motivated, with excellent knowledge of late-phase clinical trials, preferably with experience in nephrology, metabolism, and/or cell therapy. The candidate must also possess excellent leadership, communication, and organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution to timelines.

Requirements

• Protocol      and ICF development process with minimal guidance; including writing,      reviewing, adjudication/resolution of cross functional comments and      ensuring high clinical quality
• Plan      and lead the implementation all study startup/conduct/close-out activities      in partnership with Clinical Operations and collaborates with      cross-functional study team members (e.g., Regulatory Affairs, Safety,      Data Management).
• Maintain      a thorough understanding of assigned protocols and protocol requirements
• Supports the Study      Physician to coordinate relevant and timely data analyses and      presentations in collaboration with safety, data management, Data      Monitoring Committee, Biostatistics, Pharmacometrics and Biomarker teams      to meet timelines for safety monitoring committee meetings, regulatory      documents and to internal reviews to make timely program decisions      regarding study objectives.
• Assist with medical      monitoring, raising and responding to investigator queries, writing safety      narratives, etc.
• Perform      regular data reviews to identify trends.
• Support      medical data review and medical coding review.
• Trains and support study      team and CRO personnel regarding clinical aspects of trial and Identifies      program, trial or data risks, creates and implements mitigation strategies
• Review      development of site and CRA training materials and presentation at SIV and      Investigator meetings and support on study committee (e.g., DMC)      activities
• Draft/review      and validation of clinical study reports (CSRs) and clinical portions of      Regulatory Documents (e.g., IB, regulatory responses)
• Support      SAE process, query generation, narrative development and review.
• Support      labelling, distribution, and overall accountability of Clinical trial      material (CTM) for the clinical study, as needed. 

Experience/Skills:

· Bachelor’s degree required, advanced degree preferred (i.e. MS, PharmD, MPH or PhD) 

· 5 years experience in clinical development with experience in nephrology, endocrinology or metabolism preferred. 

· Significant experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.

· Significant experience with biostatistics, GCP, data integrity, exploration, analysis, regulatory requirements for clinical studies and presentation

· Ability to handle multiple projects simultaneously

· Excellent written communication, oral communication, and presentation skills are required.

· Proficient 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

· Ability to share scientific data effectively across functions and through presentations.

· Demonstrated ability to think analytically and strategically, work independently and solve problems.

· Excellent communication and interpersonal relationship skills including negotiating and relationship management skills across multiple functions and with external vendors.

· Skilled at prioritizing tasks to deliver on deadlines in a highly collaborative and collegial work style.