Clinical Director, Oncology Therapeutic Area
1 day ago
Eikon Therapeutics is a pioneering biopharmaceutical company at the forefront of revolutionary technology that converges chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Our discovery platform is built on groundbreaking innovations from our founders, culminating in the creation of microscopes that enable real-time, molecular-resolution measurements of protein movement in living cells, thereby unlocking previously intractable classes of proteins as drug targets.
Job SummaryWe are seeking a highly skilled Associate Director, Clinical Scientist (contractor) - Oncology to serve as a key role contributing to the scientific planning and collaboration with both Clinical Research, Pharmacovigilance, and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. This role requires a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California, New York, or New Jersey offices to ensure effective management, operational excellence, and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
Key Responsibilities- Lead specific aspects of clinical/scientific execution of clinical protocol(s), including serving as the lead clinical scientist on the clinical trial team and leading 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 study deliverables.
- Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming.
- Collaborate cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
- Provide 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; identify risks and design mitigation strategies.
- Promote consistent first-line medical/clinical data review techniques and conventions across studies/programs.
- A Bachelor's degree with 10+ years of relevant experience or a Post Graduate Degree with 8+ years of relevant experience in clinical research, with a strong understanding of clinical trial design, execution, and regulatory requirements.
- 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 author documents related to clinical trials, such as medical monitoring plans, 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 preferred.
Eikon Therapeutics is proud to offer a competitive hourly rate of $100/hour to $200/hour depending on skills, competency, and market demand for your expertise. We are an equal opportunity employer and will consider all qualified applicants for employment.
In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA-approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group.
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