Sr. Clinical Scientist

Summary:

Senior Clinical Scientist  -

Oncology Pharmaceutical Clinical trial industry experience required.

Hybrid role 3 days onsite. Locations east bay CA or NJ/NY

Responsibilities

• Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). 

This may include:

o Serving as the lead clinical scientist on the clinical trial team

o Leading medical monitoring team in review and interpretation of clinical data/medical

protocol deviations in collaboration with Clinical Research and Pharmacovigilance

• Collaborating cross-functionally in the development of Protocol and related study materials (e.g.,

ICF documents / amendments); partnering with Clinical Operations on study deliverables

• Ensure CRF design supports data collection in alignment with the Protocol in collaboration with

Clinical Data Management/Programming

• Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and

integrity of trial conduct

• Providing tactical/scientific mentorship to other clinical scientists

• Responsible for assisting with the generation, analysis, and presentation of clinical data, including

manuscripts, abstracts, and oral presentations (including authoring documents and slide

preparation as appropriate)

• Apply proficient analytical knowledge and skills to understand how program objectives and

design impact data analysis; identifies risks and designs mitigation strategies

• Promotes consistent first line medical/clinical data review techniques and conventions across

studies/programs. 

Qualifications

At least 5 years of relevant experience

• Master’s degree in life sciences 3 years clinical drug development experience, or PhD, Pharm

D, RN degree

• Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)

• Ability to manage multiple competing priorities with good planning, time management and

prioritization skills

• Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions  

• Proficient scientific expertise to propose, design, and execute clinical research and development

studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs,

informed consent and clinical components of the Clinical Study Reports

• Interact with key stakeholders across Clinical Development functional areas

• Role requires proactive approach, strategic thinking and leadership in driving toward clinical

study goals

• Influence opinions and decisions of internal and external customers / vendors, across functional

areas

• Problem solving, prioritization, conflict resolution and critical thinking skills

• Strong communication, technical writing, and presentation skills experience

• Experience within oncology Mandatory