Eikon Therapeutics
Senior Manager, Clinical Scientist
Eikon Therapeutics, Jersey City, New Jersey, United States, 07390
Overview
Join Eikon Therapeutics as a Senior Manager, Clinical Scientist Data Reviewer. Eikon uses revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life‑threatening diseases. The discovery platform is built on groundbreaking innovations from its founders, enabling real‑time, molecular‑resolution measurements of protein movement in living cells and unlocking otherwise intractable classes of proteins as drug targets.
Position We are seeking a Senior Manager, Clinical Scientist Data Reviewer to support scientific planning efforts and collaborate with Clinical Research, Pharmacovigilance, and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. The role focuses on detailed safety data review from study start‑up through final CSR, ensuring accuracy, integrity, and compliance with regulatory requirements. Additional growth and leadership opportunities are available.
About You You are a data‑driven integrator passionate about driving development and execution of therapeutic strategies that enable innovative pipeline impact and delivery of transformative medicines to patients. You possess exemplary communication and presentation skills and can apply current electronic document conventions/processes consistently to support scientific and data integrity.
What You’ll Do
Serve as a supportive clinical scientist data reviewer focused on safety, efficacy and critical data deliveries as part of the clinical trial team.
Support the clinical study team as part of the clinical sciences functional line closely aligned with the medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance.
Collaborate cross‑functionally in the development of protocol and related study materials (e.g., ICF documents/amendments); partner with Clinical Operations on critical and key study deliverables.
Ensure CRF design supports data collection in alignment with the protocol in collaboration with Clinical Data Management/Programming.
Review clinical data to ensure quality, completeness and integrity of trial conduct.
Provide tactical scientific mentorship to other clinical scientists and move into a Clinical Scientist lead role focusing on scientific growth and development.
Assist with 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; identify risks and design mitigation strategies.
Promote consistent first‑line medical/clinical data review techniques and conventions across studies/programs.
Qualifications
6+ years of experience with a Post Graduate Degree or 8+ years of experience with a Bachelor’s degree in a relevant scientific discipline.
Clinical drug development experience; a PhD, Pharm D, or RN degree is preferred.
Oncology experience preferred.
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 design, execute clinical research and development studies, and author documents related to clinical trials (medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Report).
Interact with key stakeholders across Clinical Development functional areas.
Proactive approach, strategic thinking and leadership in driving toward clinical study goals.
Influence opinions and decisions of internal and external customers and vendors across functional areas.
Problem solving, prioritization, conflict resolution and critical thinking skills.
Strong communication, technical writing, and presentation skills.
Benefits
401(k) plan with company matching.
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%).
Mental health and wellness benefits.
Weekend summer and winter holiday shutdowns.
Generous paid time off and holiday policies.
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee‑paid life/AD&D policies.
Enhanced parental leave benefit.
Daily subsidized lunch program when on‑site.
The expected salary range for this role is $163,000 to $178,600 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal‑opportunity employer and will consider all qualified applicants for employment.
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Position We are seeking a Senior Manager, Clinical Scientist Data Reviewer to support scientific planning efforts and collaborate with Clinical Research, Pharmacovigilance, and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. The role focuses on detailed safety data review from study start‑up through final CSR, ensuring accuracy, integrity, and compliance with regulatory requirements. Additional growth and leadership opportunities are available.
About You You are a data‑driven integrator passionate about driving development and execution of therapeutic strategies that enable innovative pipeline impact and delivery of transformative medicines to patients. You possess exemplary communication and presentation skills and can apply current electronic document conventions/processes consistently to support scientific and data integrity.
What You’ll Do
Serve as a supportive clinical scientist data reviewer focused on safety, efficacy and critical data deliveries as part of the clinical trial team.
Support the clinical study team as part of the clinical sciences functional line closely aligned with the medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance.
Collaborate cross‑functionally in the development of protocol and related study materials (e.g., ICF documents/amendments); partner with Clinical Operations on critical and key study deliverables.
Ensure CRF design supports data collection in alignment with the protocol in collaboration with Clinical Data Management/Programming.
Review clinical data to ensure quality, completeness and integrity of trial conduct.
Provide tactical scientific mentorship to other clinical scientists and move into a Clinical Scientist lead role focusing on scientific growth and development.
Assist with 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; identify risks and design mitigation strategies.
Promote consistent first‑line medical/clinical data review techniques and conventions across studies/programs.
Qualifications
6+ years of experience with a Post Graduate Degree or 8+ years of experience with a Bachelor’s degree in a relevant scientific discipline.
Clinical drug development experience; a PhD, Pharm D, or RN degree is preferred.
Oncology experience preferred.
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 design, execute clinical research and development studies, and author documents related to clinical trials (medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Report).
Interact with key stakeholders across Clinical Development functional areas.
Proactive approach, strategic thinking and leadership in driving toward clinical study goals.
Influence opinions and decisions of internal and external customers and vendors across functional areas.
Problem solving, prioritization, conflict resolution and critical thinking skills.
Strong communication, technical writing, and presentation skills.
Benefits
401(k) plan with company matching.
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%).
Mental health and wellness benefits.
Weekend summer and winter holiday shutdowns.
Generous paid time off and holiday policies.
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee‑paid life/AD&D policies.
Enhanced parental leave benefit.
Daily subsidized lunch program when on‑site.
The expected salary range for this role is $163,000 to $178,600 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal‑opportunity employer and will consider all qualified applicants for employment.
#J-18808-Ljbffr