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kps life · 6 days ago

Sr. Clinical Scientist, Clinical Development

Bridgewater, NJ

Full-time

Onsite

Mid, Senior Level

2+ years exp

KPS Life is a company focused on advancing clinical research, and they are seeking a Sr. Clinical Scientist for Clinical Development. This role involves providing expert clinical advice across all phases of clinical research, leading clinical development scientists, and overseeing the execution of clinical trials.

Health CareMedicalWellness

Responsibilities

Lead clinical development scientists for the development and execution of clinical trials under the responsible therapeutic indication

Review, guide and approve protocols, and amendments, ICFs, and clinical sections of other documents

Interact with thought leaders within the respective therapeutic area/indication

Track and update CD team on the CD deliverables across all clinical studies/projects

Lead identifying, contracting, and engaging subject matter experts/thought leaders in advisory board meetings, consultancy etc

Oversee regular maintenance and update of the CD project folders/drives

Review, guide and finalize study documents such as Protocol Synopses, Protocols, Protocol amendments, Administrative Change letters etc

Ensure CD contributions to trial-related documents such as the IBs, ICF, CRFs, CRF Completion Guidelines, Study Execution and Monitoring Plans, Clinical Data Review Plan, Clinical Database specifications, statistical analysis plan, the data management plan, the medical monitoring plan, Clinical Study Report (CSR) etc

Ensure regular and ad-hoc data reviews and interpretation; preparation of summaries/documentations of these reviews to Senior Director/Director, clinical development

Ensure timely development of program-level documents, including, but not limited to, abstract and manuscripts, presentations, and various other internal and external documents and communications as needed

In collaboration with the Development Operations staff, the Sr. Clinical Scientist develops operational strategies for clinical research studies and development programs including, but not limited to, PI selection, CRO selection, budgets, and timelines

Ensure CD participation in vendor selection, specification development, and management/oversight, as needed

Facilitation of country and site feasibility/selection processes

Ensure development of study specific training materials for study team, investigational sites, and vendors

Participate and present at Investigator meetings or similar

Handle scientific and data-related queries

Collaborate with statistician in data review and interpretation

Collaborate with the medical monitor and/or clinical safety scientist to identify any trial-related safety trends, and as needed, generate reports to interpret, analyze and summarize the data and trends

Collaborate with the statistician to identify any trial-related efficacy trends, and as needed, generate reports to interpret, analyze and summarize the data and trends

Other tasks as assigned by Study Sponsor or direct supervisor

Qualification

Clinical development experienceProtocol designDevelopmentICH E6 GCP knowledgeTherapeutic area experienceData analysisInterpretationStrategic thinkingCommunication skillsTeam leadership

Required

2-4 years of clinical development experience (pharma, CRO) with M.D./D.O. or equivalent foreign degree

1-3 years of experience in clinical development within Industry (pharmaceutical, CRO)

Previous experience designing and developing phase 1-4 protocols

Therapeutic area experience (demonstrable with 2 or more years relevant experience)

Demonstrates ability to analyze and interpret data, assess clinical relevance and present/report findings (e.g., ISS, ISE, competitor data, etc.)

Proven current working knowledge of ICH E6 GCP and required local regulations, applicable and/or related to the performance of role duties and activities